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  • Dynamic LED light versus static LED light for depressed inpatients: results from a randomized feasibility trial
    Pilot Feasibility Stud. (IF 0) Pub Date : 2020-01-15
    Carlo Volf; Anne Sofie Aggestrup; Signe Dunker Svendsen; Torben Skov Hansen; Paul Michael Petersen; Carsten Dam-Hansen; Ulla Knorr; Ema Erkocevic Petersen; Janus Engstrøm; Ida Hageman; Janus Christian Jakobsen; Klaus Martiny

    Retrospective studies conducted in psychiatric wards have indicated a shorter duration of stay for depressed inpatients in bright compared to dim daylight-exposed rooms, pointing to a possible antidepressant effect of daylight conditions. Dynamic LED lighting, aiming to mimic daylight conditions, are currently been installed in several hospitals, but their feasibility is poorly investigated. To investigate the feasibility of these systems, we developed and installed a LED-lighting system in four rooms in a psychiatric inpatient ward. The system could function statically or dynamically regarding light intensity and colour temperature. The system consisted of (A) a large LED luminaire built into the window jamb mimicking sunlight reflections, (B) two LED light luminaires in the ceiling and (C) a LED reading luminaire. In the static mode, the systems provided constant light from A and B. In the dynamic mode, the system changed light intensity and colour temperature using A, B and C. Patients with unipolar or bipolar depression were randomised to dynamic or static LED lighting for 4 weeks, in addition to standard treatment. Primary outcome was the rate of patients discontinuing the trial due to discomfort from the lighting condition. Secondary outcomes were recruitment and dropout rates, visual comfort, depressive symptoms and suicidal ideation. No participants discontinued due to discomfort from the LED lighting. Recruitment rate was 39.8%, dropout from treatment rates were 56.3% in the dynamic group and 33.3% in the static group. 78.1% in the dynamic group were satisfied with the lighting compared with 71.8% in the static group. Discomfort from the light (glare) was reported by 11.5% in the dynamic group compared to 5.1% in the static group. Endpoint suicidal scores were 16.8 (10.4) in the dynamic and 16.3 (14.9) in the static group. The lighting system was 100% functional. The light sensor system proved unstable. Dropout from treatment was high primarily due to early discharge and with a lack of endpoint assessments. The feasibility study has influenced an upcoming large-scale dynamic lighting efficacy trial where we will use a shorter study period of 3 weeks and with more emphasis on endpoint assessments. The lighting was well tolerated in both groups, but some found intensity too low in the evening. Thus, we will use higher intensity blue-enriched light in the morning and higher intensity amber (blue-depleted) light in the evening in the upcoming study. The light sensor system needs to be improved ClinicalTrials.gov: NCT03363529

    更新日期:2020-01-15
  • Feasibility of alcohol screening and brief intervention in primary health care in Kazakhstan: study protocol of a pilot cluster randomised trial
    Pilot Feasibility Stud. (IF 0) Pub Date : 2020-01-09
    Bernd Schulte; Amy O’Donnell; Harald Lahusen; Christina Lindemann; Mariya Prilutskaya; Oleg Yussopov; Zhanar Kaliyeva; Marcus-Sebastian Martens; Uwe Verthein

    Identifying and addressing heavy drinking represents a major public health priority worldwide. Whilst the majority of alcohol screening and brief intervention (ASBI) research has been conducted in western, high-income countries, evidence is growing that ASBI can also impact positively on heavy drinkers in low- and middle-income country populations. This mixed methods study aims to assess the feasibility of conducting a fully randomised controlled trial of the effectiveness of ASBI in primary care in Kazakhstan and explore the feasibility and acceptability of implementing ASBI in this setting from patients’ and physicians’ perspectives. Six primary health care units in the region of Pavlodar will be cluster randomised to either an intervention (WHO manualised 5 min alcohol brief intervention plus alcohol leaflet) or control group (simple feedback plus alcohol leaflet). Primary feasibility measures will be rates of participation at baseline and retention of eligible patients at the 3-month follow-up point. Patient/physician questionnaires and physician focus groups will assess additional dimensions of feasibility, as well as acceptability, according to the RE-AIM framework: Reach (rates of eligible patients screened/received advice); Effectiveness (change in AUDIT-C score); Adoption (rate/representativeness of participating physicians); Implementation (quality of ASBI/barriers and facilitators to delivery); and Maintenance (potential sustainability of intervention). This is the first trial of the feasibility and acceptability of ASBI in Kazakhstan. As the planning and assessment of implementation determinants is based on the RE-AIM framework, the project outcomes will be relevant for the future development, tailoring and implementation of ASBI in Kazakhstan. DRKS, DRKS00015882, Registered 17 December 2018.

    更新日期:2020-01-11
  • The long-term health and wellbeing impacts of Healthy New Towns (HNTs): protocol for a baseline and feasibility study of HNT demonstrator sites in England
    Pilot Feasibility Stud. (IF 0) Pub Date : 2020-01-10
    Paul Watts; Susanna Rance; Victoria McGowan; Heather Brown; Clare Bambra; Gail Findlay; Angela Harden

    Increasing levels of non-communicable diseases (NCDs), mental health problems, high rates of unhealthy behaviours and health inequalities remain major public health challenges worldwide. In the context of increasing urbanisation, there is an urgent need to understand how evidence that living environments shape health, wellbeing and behaviour can be used to design and deliver healthy environments in local urban settings. The Healthy New Town (HNT) programme implemented in England from 2015 consists of ten major housing developments that aim to improve population health through healthy design principles, new models for integrating health and social care and the creation of strong and connected communities. The programme provides a natural experiment in which to investigate the effects on health, wellbeing and inequalities of large-scale interventions targeting the wider social determinants of health. The research described in this protocol aims to examine the feasibility of a larger study to assess the longer-term health impacts of HNTs, by addressing two research questions: (1) what are the similarities and differences in the HNT programme developments, processes, contexts and expected impacts and outcomes across HNT sites? and (2) how feasible is the use of data from routine sources and existing HNT evaluations and as the baseline for a definitive study to assess impact on health, wellbeing, behavioural and economic outcomes and programme processes? The research will consist of (a) participatory systems mapping with stakeholders to produce a theoretical framework for a longer-term study on the HNT programme, (b) synthesis of existing qualitative data from local HNT evaluations to understand local processes and intervention mechanisms, (c) scoping local and routinely available data to establish a baseline and feasibility for a longer-term study of health and economic outcomes, and (d) building relationships and recruiting HNT sites into the proposed research. The proposed research will produce a theoretical framework and assess the feasibility of a definitive study of outcomes of the HNT programme. This research is necessary to understand how longer-term health, wellbeing, behavioural and economic outcomes can be measured, and to inform a definitive study to generate evidence on the effectiveness of the HNT programme.

    更新日期:2020-01-11
  • Prostate cancer survivors’ preferences on the delivery of diet and lifestyle advice: a pilot best-worst discrete choice experiment
    Pilot Feasibility Stud. (IF 0) Pub Date : 2020-01-06
    Luke A. Robles; Stuart J. Wright; Lucy Hackshaw-McGeagh; Ellie Shingler; Constance Shiridzinomwa; J. Athene Lane; Richard M. Martin; Sorrel Burden

    Lifestyle factors, including diet and physical activity, are associated with prostate cancer progression and mortality. However, it is unclear how men would like lifestyle information to be delivered following primary treatment. This study aimed to identify men’s preferences for receiving lifestyle information. We conducted a cross-sectional pilot best-worst discrete choice experiment which was nested within a feasibility randomised controlled trial. Our aim was to explore men’s preferences of receiving diet and physical activity advice following surgery for localised prostate cancer. Thirty-eight men with a mean age of 65 years completed best-worst scenarios based on four attributes: (1) how information is provided; (2) where information is provided; (3) who provides information; and (4) the indirect cost of receiving information. Data was analysed using conditional logistic regression. Men’s willingness to pay (WTP) for aspects of the service was calculated using an out-of-pocket cost attribute. The combined best-worst analysis suggested that men preferred information through one-to-one discussion β = 1.07, CI = 0.88 to 1.26) and not by email (β = − 1.02, CI = − 1.23 to − 0.80). They preferred information provided by specialist nurses followed by dietitians (β = 0.76, CI = 0.63 to 0.90 and − 0.16, CI = − 0.27 to − 0.05 respectively) then general nurses (β = − 0.60, CI = − 0.73 to − 0.48). Three groups were identified based on their preferences. The largest group preferred information through individual face-to-face or group discussions (β = 1.35, CI = 1.05 to 1.63 and 0.70, CI = 0.38 to 1.03 respectively). The second group wanted information via one-to-one discussions or telephone calls (β = 1.89, CI = 1.41 to 2.37 and 1.03, CI = 0.58 to 1.48 respectively), and did not want information at community centres (β = − 0.50, CI = − 0.88 to − 0.13). The final group preferred individual face-to-face discussions (β = 0.45, CI = 0.03 to 0.88) but had a lower WTP value (£17). Men mostly valued personalised methods of receiving diet and physical activity information over impersonal methods. The out-of-pocket value of receiving lifestyle information was important to some men. These findings could help inform future interventions using tailored dietary and physical activity advice given to men by clinicians following treatment for prostate cancer, such as mode of delivery, context, and person delivering the intervention. Future studies should consider using discrete choice experiments to examine information delivery to cancer survivor populations.

    更新日期:2020-01-07
  • Use of robot technology in passive mobilization of acute hospitalized geriatric medicine patients: a pilot test and feasibility study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2020-01-06
    AS. Bertelsen; A. Storm; L. Minet; J. Ryg

    Along with an aging population, the field of robot technology in rehabilitation is expanding. As new technologies develop, it is important to test these clinically before implementation. To assess the possibilities of undertaking a future randomized controlled trial (RCT), the aim of this study was to pilot test and investigate the feasibility of a newly developed passive mobilization robot device in geriatric medicine patients. We used a robot to perform passive mobilization for all recruited patients while they were lying in bed. Inclusion criteria include the following: ≥ 65 years of age, able to walk before hospitalization, and not capable of walking > 2 m at the first day of hospitalization. Exclusion criteria include the following: known moderate/severe dementia, unstable fractures (back, pelvis, or legs), high intracranial pressure, pressure ulcers/risk of developing pressure ulcers due to fragile skin, positive Confusion and Assessment Method (CAM) score, not able to understand Danish, and medical instability. A mixed-methods approach, including structured interviews for patients and relatives, questionnaires and semi-structured interviews for the staff, and observations in the clinic were used as data collection methods. A 6-week pilot test preceded the feasibility study to test study design, safety, interview guide, and setting, and to become familiar with the robot. The pilot test included 13 patients, made the staff confident in the use of the robot, and led to the correction of the interview guide. In the feasibility study, 177 patients were screened, 14 patients (four men, nine women) included, and 13 completed the intervention (median [IQR] age 86 [82–92] years). Overall, the robot was easy to use during passive mobilization and fully accepted by patients and relatives. Staff, however, found the robot difficult to maneuver. No adverse events were reported. Use of robot technology in passive mobilization of older patients was feasible and well accepted by patients, relatives, and staff. Technical and workflow-related issues, as well as the robot not performing active mobilization, affects the launch of a RCT and thereby its implementation in geriatric medicine patients.

    更新日期:2020-01-06
  • Development of mass media resources to improve the ability of parents of primary school children in Uganda to assess the trustworthiness of claims about the effects of treatments: a human-centred design approach
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-29
    Daniel Semakula; Allen Nsangi; Matt Oxman; Sarah Ellen Rosenbaum; Andrew David Oxman; Astrid Austvoll-Dahlgren; Claire Glenton; Simon Lewin; Margaret Kaseje; Angela Morelli; Atle Fretheim; Nelson Kaulukusi Sewankambo

    Claims about what we need to do to improve our health are everywhere. Most interventions simply tell people what to do, and do not empower them to critically assess health information. Our objective was to design mass media resources to enable the public to critically appraise the trustworthiness of claims about the benefits and harms of treatments and make informed health choices. Research was conducted between 2013 and 2016 across multiple iterative phases. Participants included researchers, journalists, parents, other members of the public. First, we developed a list of 32 key concepts that people need to understand to be able to assess the trustworthiness of claims about treatment effects. Next, we used a human-centred design approach, to generate ideas for resources for teaching the key concepts, and developed and user-tested prototypes through qualitative interviews. We addressed identified problems and repeated this process until we had a product that was deemed relevant and desirable by our target audience, and feasible to implement. We generated over 160 ideas, mostly radio-based. After prototyping some of these, we found that a podcast produced collaboratively by health researchers and journalists was the most promising approach. We developed eight episodes of the Informed Health Choices podcast, a song on critical thinking about treatments and a reminder checklist. Early versions of the podcast were reportedly too long, boring and confusing. We shortened the episodes, included one key concept per episode, and changed to story-telling with skits. The final version of the podcast was found to be useful, understandable, credible and desirable. We found many problems with various prototypes of mass media resources. Using a human-centred design approach, we overcame those problems. We have developed a guide to help others prepare similar podcasts.

    更新日期:2019-12-30
  • Extra upper limb practice after stroke: a feasibility study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-30
    Emma J. Schneider; Louise Ada; Natasha A. Lannin

    There is a need to provide a large amount of extra practice on top of usual rehabilitation to adults after stroke. The purpose of this study was to determine if it is feasible to add extra upper limb practice to usual inpatient rehabilitation and whether it is likely to improve upper limb activity and grip strength. A prospective, single-group, pre- and post-test study was carried out. Twenty adults with upper limb activity limitations who had some movement in the upper limb completed an extra hour of upper limb practice, 6 days per week for 4 weeks. Feasibility was measured by examining recruitment, intervention (adherence, efficiency, acceptability, safety) and measurement. Clinical outcomes were upper limb activity (Box and Block Test, Nine-Hole Peg Test) and grip strength (dynamometry) measured at baseline (week 0) and end of intervention (week 4). Of the 212 people who were screened, 42 (20%) were eligible and 20 (9%) were enrolled. Of the 20 participants, 12 (60%) completed the 4-week program; 7 (35%) were discharged early, and 1 (5%) withdrew. Participants attended 342 (85%) of the possible 403 sessions and practiced for 324 (95%) of the total 342 h. In terms of safety, there were no study-related adverse events. Participants increased 0.29 blocks/s (95% CI 0.19 to 0.39) on the Box and Block Test, 0.20 pegs/s (95% CI 0.10 to 0.30) on the Nine-Hole Peg Test, and 4.4 kg (95% CI 2.9 to 5.9) in grip strength, from baseline to end of intervention. It appears feasible for adults who are undergoing inpatient rehabilitation and have some upper limb movement after stroke to undertake an hour of extra upper limb practice. The magnitude of the clinical outcomes suggests that further investigation is warranted and this study provides useful information for the design of a phase II randomized trial. Australian and New Zealand Clinical Trial Registry (ACTRN12615000665538).

    更新日期:2019-12-30
  • The feasibility and acceptability of a primary school-based programme targeting diet and physical activity: the PhunkyFoods Programme
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-20
    Pinki Sahota; Meaghan Christian; Rhiannon Day; Kim Cocks

    This study aims to evaluate the feasibility and acceptability of the PhunkyFoods Programme, a primary school-based intervention to promote healthy nutrition and physical activity knowledge and behaviours to assess outcomes to inform a phase 3 trial. The cluster randomised feasibility trial recruited eight primary schools from the North of England. Elibility criteria included all primary schools in one town, excluding independent and special schools and schools that comprised of only key stage 2 pupils (years 3–6). Eight schools agreed to participate. Randomisation to intervention or control arms was in a 1:1 ratio. Intervention schools received PhunkyFoods over 17 months. Control schools continued with usual curriculum. Assessors were blinded to group assignment. Measures comprised of a Healthy Lifestyle Knowledge Questionnaire and Synchronised Nutrition and Activity Program to assess diet and physical activity, height, weight, and psychological wellbeing. Feasibility outcomes were recruitment, attrition rates, interviews with teaching staff, focus groups with pupils to explore the acceptability of outcome measures, implementation, intervention content, and programme fidelity. Three hundred fifty-eight pupils, aged 6–9 years from eight schools were recruited at baseline (control n = 170, intervention n = 188); 337 (94.1%) at 6 months (control n = 163, intervention n = 181); and 331 (92.5%) at 18 months (control n = 152, intervention n = 179), and 6 pupils opted out. Trends in increased knowledge of healthy lifestyle behaviours, healthier eating, and liking of fruit and vegetables were reported in the intervention compared to the control group. Year 4 intervention pupils had significantly higher healthy balanced diet knowledge scores compared to control pupils, mean difference 5.1 (95% CI 0.1 to 10.1, p=0.05). At 18 months, the mean percentage of vegetables liked was higher (intervention 53.9% vs. 43.0% control). Similarly, percentage of fruits liked was also higher (intervention 76.9% vs. 67.2% control). Qualitative data showed that delivery of the intervention was feasible and acceptable to teachers and pupils. Lessons were learned to inform the phase 3 trial around the dietary assessment measure and timing of recruitment. Whilst the study was not powered to detect a definitive effect, results suggest a potential to increase knowledge of healthy lifestyle behaviours and dietary behaviours, suggesting that with minor changes, a phase 3 trial is likely to be deliverable. ISRCTN, ISRCTN15641330. Registered 8 May 2015—retrospectively registered, https://doi.org/10.1186/ISRCTN15641330

    更新日期:2019-12-21
  • Intervention planning and modification of the BUMP intervention: a digital intervention for the early detection of raised blood pressure in pregnancy
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-20
    Rebecca Band; Lisa Hinton; Katherine L. Tucker; Lucy C. Chappell; Carole Crawford; Marloes Franssen; Sheila Greenfield; James Hodgkinson; Christine McCourt; Richard J. McManus; Jane Sandall; Mauro Dala Santos; Carmelo Velardo; Lucy Yardley

    Hypertensive disorders in pregnancy, particularly pre-eclampsia, pose a substantial health risk for both maternal and foetal outcomes. The BUMP (Blood Pressure Self-Monitoring in Pregnancy) interventions are being tested in a trial. They aim to facilitate the early detection of raised blood pressure through self-monitoring. This article outlines how the self-monitoring interventions in the BUMP trial were developed and modified using the person-based approach to promote engagement and adherence. Key behavioural challenges associated with blood pressure self-monitoring in pregnancy were identified through synthesising qualitative pilot data and existing evidence, which informed guiding principles for the development process. Social cognitive theory was identified as an appropriate theoretical framework. A testable logic model was developed to illustrate the hypothesised processes of change associated with the intervention. Iterative qualitative feedback from women and staff informed modifications to the participant materials. The evidence synthesis suggested women face challenges integrating self-monitoring into their lives and that adherence is challenging at certain time points in pregnancy (for example, starting maternity leave). Intervention modification included strategies to address adherence but also focussed on modifying outcome expectancies, by providing messages explaining pre-eclampsia and outlining the potential benefits of self-monitoring. With an in-depth understanding of the target population, several methods and approaches to plan and develop interventions specifically relevant to pregnant women were successfully integrated, to address barriers to behaviour change while ensuring they are easy to engage with, persuasive and acceptable.

    更新日期:2019-12-21
  • Exploring the feasibility and acceptability of a mixed-methods pilot randomized controlled trial testing a 12-week physical activity intervention with adolescent and young adult cancer survivors
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-20
    Amanda Wurz; Jennifer Brunet

    Adolescent and young adult (AYA) cancer survivors (i.e. individuals diagnosed with cancer between 15 and 39 years and who completed treatment) may benefit from physical activity. Yet, few researchers have explored the effects of physical activity on physical and psychological outcomes among AYA cancer survivors. A pilot study exploring the feasibility and acceptability of a physical activity intervention and proposed trial methods to inform a definitive randomized controlled trial (RCT) is therefore necessary to fill this gap. A two-arm, mixed-methods pilot RCT was conducted. Participants were randomized to a wait-list control group or a 12-week physical activity intervention comprised of 4 weekly aerobic and strength training sessions (intervention group). Feasibility measures included: number of AYA cancer survivors referred/self-referred, eligible, and recruited, retention to the trial (i.e. assessment completion), adherence to the physical activity intervention, and percentage of missing data for baseline (week 0), mid- (week 6), and post-intervention assessments (week 12). The acceptability of trial methods (all participants) and the intervention (intervention group only) was assessed via qualitative interviews post-intervention. Over a 12-month period, 31 AYA cancer survivors were referred/self-referred and 16 were eligible and consented to participate. Retention to the trial was 94% and adherence to the physical activity intervention ranged from 50 to 92%. With the exception of the assessment of aerobic capacity and directly measured physical activity behaviour, there were no missing data. Participants generally reported being satisfied with the trial methods and intervention; however, issues related to delivery of the physical activity intervention were identified. The methods and intervention piloted require modification and further pilot testing in advance of a definitive RCT. Recruitment strategies identifying a greater number of younger AYA cancer survivors who have different types of cancers and who lack motivation to participate in physical activity-based studies should be explored. Refining the assessments of directly measured physical activity behaviour and aerobic capacity and incorporating behavioural support into the intervention may improve feasibility and acceptability. This study highlights the value of doing pilot work and provides critically useful data that can be used to refine studies seeking to assess causation and optimize physical activity interventions for AYA cancer survivors. clinicaltrials.gov, NCT03016728. Registered January 11, 2017.

    更新日期:2019-12-21
  • Results of the feasibility phase of the managed activity graded exercise in teenagers and pre-adolescents (MAGENTA) randomised controlled trial of treatments for chronic fatigue syndrome/myalgic encephalomyelitis
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-19
    Amberly Brigden; Lucy Beasant; Daisy Gaunt; William Hollingworth; Nicola Mills; Emma Solomon-Moore; Russell Jago; Chris Metcalfe; Kirsty Garfield; Charlotte Wray; Adam Trist; Victoria Vilenchik; Caroline Grayson; Esther Crawley

    Chronic fatigue syndrome (CFS) also known as myalgic encephalomyelitis (ME) is relatively common in young people and causes significant disability. Graded exercise therapy (GET) and activity management are recommended by the National Institute for Health and Care Excellence (NICE) despite a limited evidence-base for either treatment in paediatric CFS/ME. This paper reports on feasibility and acceptability measures from the feasibility phase of the ongoing MAGENTA randomised controlled trial (RCT) investigating GET versus activity management for young people with CFS/ME. Setting: Three specialist secondary care National Health Service (NHS) Paediatric CFS/ME services (Bath, Cambridge and Newcastle). Participants: Young people aged 8–17 years with a diagnosis of mild to moderate CFS/ME. Young people were excluded if they were severely affected, referred to cognitive behavioural therapy (CBT) at initial assessment or unable to attend clinical sessions. Interventions: GET and activity management delivered by physiotherapists, occupational therapists, nurses and psychologists. Families and clinicians decided the number (typically 8–12) and frequency of appointments (typically every 2–6 weeks). Outcome Measures: Recruitment and follow-up statistics. We used integrated qualitative methodology to explore the feasibility and acceptability of the trial processes and the interventions. 80/161 (49.7%) of eligible young people were recruited at two sites between September 2015 and August 2016, indicating recruitment to the trial was feasible. Most recruitment (78/80; 97.5%) took place at one centre. Recruitment consultations, online consent and interventions were acceptable, with less than 10% in each arm discontinuing trial treatment. Response rate to the primary outcome (the SF36-PFS at 6 months) was 91.4%. Recruitment, treatment and data collection were not feasible at one centre. The site was withdrawn from the study. In response to data collected, we optimised trial processes including using Skype for recruitment discussions; adapting recruiter training to improve recruitment discussions; amending the accelerometer information leaflets; shortening the resource use questionnaires; and offering interventions via Skype. These amendments have been incorporated into the full trial protocol. Conducting an RCT investigating GET versus activity management is feasible and acceptable for young people with CFS/ME. ISRCTN23962803 https://doi.org/10.1186/ISRCTN23962803, date of registration: 03 September 2015

    更新日期:2019-12-20
  • Feasibility, user experiences, and preliminary effect of Conversation Cards for Adolescents© on collaborative goal-setting and behavior change: protocol for a pilot randomized controlled trial
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-18
    M. Kebbe; A. Farmer; M. P. Dyson; S. D. Scott; T. L. F. McHugh; S. Lappa; H. Rajani; T. Ladha; B. Islam; L. Jacoby; F. Nasir; K. Talwar; J. L. Wincott; M. Zhang; G. D. C. Ball

    Adolescents and providers can benefit from practical tools targeting lifestyle modification for obesity prevention and management. We created Conversation Cards for Adolescents© (CCAs), a patient-centered communication and behavior change tool for adolescents and providers to use in clinical practice. The purpose of our study is to (i) assess the feasibility of CCAs in a real-world, practice setting to inform full-scale trial procedures, (ii) assess user experiences of CCAs, and (iii) determine the preliminary effect of CCAs on changing behavioral and affective-cognitive outcomes among adolescents. Starting in early 2019, this prospective study is a nested mixed-methods, theory-driven, and pragmatic pilot randomized controlled trial with a goal to enroll 50 adolescents (13–17 years old) and 9 physicians practicing at the Northeast Community Health Centre in Edmonton, Alberta, Canada. Adolescents will collaboratively set one S.M.A.R.T. (specific, measurable, attainable, realistic, timely) goal with their physician to implement over a 3-week period; however, only those randomized to the experimental group will use CCAs to inform their goal. Outcome assessments at baseline and follow-up (3 weeks post-baseline) will include behavioral, affective-cognitive, and process-related outcomes. In examining the feasibility, user experiences, and preliminary effect of CCAs, our study will add contributions to the obesity literature on lifestyle modifications among adolescents in a real-world, practice setting as well as inform the scalability of our approach for a full-scale effectiveness randomized controlled trial on behavior change. ClinicalTrials.gov Identifier: NCT03821896.

    更新日期:2019-12-19
  • Nurse-led video-coaching interventions in childhood, adolescent and young adult cancer survivors (REVIVER): a protocol for mixed methods feasibility research
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-18
    Eline Bouwman; Rosella P. M. G. Hermens; Nicole M. A. Blijlevens; Judith B. Prins; Jacqueline J. Loonen

    Successful cancer treatment can lead to cancer survivors being predisposed to an increased lifelong risk of adverse late health effects. Therefore, high-quality cancer survivorship care to earlier detect and treat late effects or to preserve survivor’s health is essential. Nevertheless, this care needs to be sustainable and cost-effective as well. We developed three different screen-to-screen nurse-led eHealth interventions for survivors of childhood, adolescent and young adult-onset cancer, collectively called the REVIVER interventions. Elaborating on person-centred care principles with content based on cognitive behavioural therapy modules and/or motivational interviewing techniques, these interventions aim to empower and coach survivors to improve (1) symptoms of cancer-related fatigue, (2) self-efficacy and self-management or (3) lifestyle. With the REVIVER study, we aim to evaluate the interventions’ feasibility and gain insights into the potential effectiveness. The REVIVER study involves a mixed methods design, including (1) interviews till data saturation with cancer survivors who completed the interventions as well as with all involved medical professionals, (2) reviews of nurses reports and (3) a single-group, pre-post evaluation among cancer survivors. Eligible survivors are survivors of childhood, adolescent and young adult-onset cancer who are referred to one of the interventions, in complete remission of cancer, 16–44 years old at enrolment, completed treatment at least 5 years ago and have access to a device with Internet options. We will assess feasibility in terms of demand, adherence, acceptability, practicality and integration/implementation. Health-related quality of life, as primary outcome of the potential effectiveness evaluation, will be assessed at three different time points: prior to the intervention; immediately following the intervention and 6 months post-intervention. Secondary outcome measures include changes in level of fatigue, self-efficacy, self-management and lifestyle. This is the first study to evaluate the feasibility and potential effectiveness of eHealth nurse-led interventions elaborating on person-centred care, using cognitive behavioural therapy and/or motivational interviewing techniques as an innovative and promising approach for providing CAYA cancer survivorship care. If the interventions prove to be feasible and potential effective, a randomized controlled trial will be conducted to test the (cost)-effectiveness.

    更新日期:2019-12-19
  • Adapting TeamSTEPPS for school mental health teams: a pilot study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-17
    Courtney Benjamin Wolk; Rebecca E. Stewart; Peter Cronholm; Ricardo Eiraldi; Eduardo Salas; David S. Mandell

    School mental health care often is provided by teams contracted from community mental health agencies. The team members that provide this care, however, do not typically receive training in how to work effectively in a team-based context. Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) provides a promising, evidence-based strategy for improving communication and climate in school-based teams. In collaboration with stakeholders, we adapted and piloted TeamSTEPPS for use with school mental health teams. Teams in six schools were randomized to receive the adapted TeamSTEPPS approach or usual supports. The main outcomes of interest were feasibility and acceptability of the adapted TeamSTEPPS strategy. Results indicated that team member burnout was significantly higher at follow-up than pretreatment for both control and intervention teams. TeamSTEPPS was feasible and acceptable to implement, and leadership emerged as an important facilitator. Barriers to implementation success included staff turnover, lack of resources, and challenges in the school mental health team relationship. Additional supports to implement TeamSTEPPS were suggested, including ongoing consultation and booster training to address high staff turnover. Results suggest that TeamSTEPPS is promising for school mental health teams but additional modifications are likely needed.

    更新日期:2019-12-18
  • A pilot summer day camp cooking curriculum to influence family meals
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-13
    Lindy Williams; Aleshia Magee; Cameron Kilby; Katherine Maxey; Joseph A. Skelton

    Efforts to combat the epidemic of childhood obesity have approached the issue from many different angles, with a family approach being the gold standard. While most efforts focus on the parents, few have viewed the child as the agent of change. In this study, we explored the feasibility of implementing a cooking curriculum into a summer day camp to determine its reception and explore the potential of home reach. In partnership with a local YMCA, a child-focused cooking curriculum was developed, designed to be delivered to various age groups with key nutritional messages. Interviews were conducted with participating children and their parents to determine acceptability and potential to influence the home environment as well as explore children’s understanding of nutrition and cooking topics. Children in the study ranged from 7 to 15 years of age. Children overwhelmingly enjoyed the cooking camp and talked about it with their parents at home. Almost all parents had plans to try the recipes at home, and many had already made one or more of the recipes. It is feasible to incorporate cooking lessons into a children’s summer day camp, with some evidence of reach into the home. Future studies should evaluate children as agents of change in cooking and meal preparation, and assess if this could increase the number and quality of family meals.

    更新日期:2019-12-17
  • A virtual reality intervention for fear of movement for Veterans with chronic pain: protocol for a feasibility study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-11
    Christopher A. Fowler; Lisa M. Ballistrea; Kerry E. Mazzone; Aaron M. Martin; Howard Kaplan; Kevin E. Kip; Jennifer L. Murphy; Sandra L. Winkler

    A key concern for people with chronic pain is experiencing increased pain and/or re-injury. Consequently, individuals with chronic pain can develop a maladaptive fear of movement that leads to adverse functional consequences. A primary goal of chronic pain rehabilitation is re-engagement in feared movements through exposure. This is often challenging since safe movement can be uncomfortable. Virtual environments provide a promising opportunity to safely and gradually expose Veterans to movements that are avoided in the real world. The current study will utilize multiple virtual reality (VR) applications (APPs) of varying the intensity levels ranging from passive distraction from pain to active exposure to feared movement. The primary aims of this pilot are to examine VR as an adjunctive nonpharmacological intervention to assist with the adoption and implementation of skills to decrease fear of movement and increase overall functioning among Veterans with chronic pain. Second, to build a hierarchy of VR APPs to assist in gradual exposure to feared movements. This study will be conducted in the Chronic Pain Rehabilitation Program (CPRP) at the James A. Haley Veterans Hospital, a unique inpatient program within the VA system. Participants will include up to 20 Veterans who receive a VR intervention as part of their physical therapy. A rating form containing qualitative and quantitative experiences will be administered following each VR session to assess feasibility and to provide descriptive information for the proposed hierarchy. Effect sizes will be calculated from intake and discharge measures for the primary outcome fear of movement and secondary pain and functional outcomes. This study will inform the feasibility of a randomized controlled trial examining the clinical utility of using VR to reduce fear of movement and increase function among Veterans with chronic pain. VR has the advantage of being easily implemented both within VA healthcare settings as well as in Veterans’ own residences, where engagement in ongoing self-management approaches is often most challenging. Presumably, VR that is matched to patient needs, progresses in intensity, immerses Veterans in the applications, and is perceived positively by Veterans, will result in positive functional outcomes.

    更新日期:2019-12-11
  • The Frailty Risk Score predicts length of stay and need for rehospitalization after kidney transplantation in a retrospective cohort: a pilot study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-10
    Joanna Schaenman; Loren Castellon; Emily C. Liang; Deepa Nanayakkara; Basmah Abdalla; Catherine Sarkisian; Deena Goldwater

    Frailty is a widely used measure in older patients as a predictor of poor outcomes after hospitalization and surgery. There is a growing body of data in kidney transplantation suggesting frailty can predict adverse outcomes. There is interest in using chart review measures of frailty and multimorbidity, as they may be equally predictive as physical measurement. This approach holds promise for patient evaluation, identifying candidates for prehabilitation, and targeting resources towards those anticipated to have an increased rate of clinical challenges after kidney transplantation. Frail patients who are often older may place a large resource and economic burden on transplant programs. We applied a previously published chart review–based approach in a retrospective, pilot study to calculate the Frailty Risk Score (FRS) utilizing a cohort of kidney transplant patients. We reviewed concurrent comorbidities using the Charlson comorbidity (CM) score to determine the feasibility and utility of applying this approach in transplant patients to predict post-transplant outcomes such as length of hospitalization and the need for rehospitalization. Sixty kidney transplant recipients were evaluated by chart review, 23 characterized as older (> = 60) and 37 younger (ages 30–59). Median FRS score was 3 (range 1–7). Higher FRS was significantly associated with increased patient age (high FRS 19% in younger patients, 43% in older patients). Increased CM score was also associated with increased patient age. Patients with a high FRS stayed in the hospital for an average of 8 days, compared with 5.7 days for a low FRS. Patients with high FRS were readmitted an average of 2.9 times compared with an average of 1.1 for those with a low FRS. FRS score remained significant for predicting outcomes after adjustment for patient age. Elevated FRS prior to transplantation was associated with increased hospital stay and the need for readmission in kidney transplant recipients. This analysis demonstrates the potential strength of chart review in evaluating frailty prior to transplantation, permitting risk stratification and targeting of resources for rehabilitation and close post-transplant monitoring. Frail patients may benefit from targeted “prehabilitation” to attenuate the associated adverse clinical outcomes.

    更新日期:2019-12-11
  • Cognitive-behavioural therapy for the management of inflammatory bowel disease-fatigue: a feasibility randomised controlled trial
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-10
    Micol Artom; Wladyslawa Czuber-Dochan; Jackie Sturt; Hannah Proudfoot; Danniella Roberts; Christine Norton

    Fatigue is the third most prevalent symptom for patients with inflammatory bowel disease (IBD), yet optimal strategies for its management are unclear. Treatment protocols for fatigue in other conditions have been based on cognitive-behavioural models. Targeting cognitions, emotions and behaviour related to fatigue through cognitive-behavioural therapy (CBT) may be a viable option to improve fatigue and quality of life (QoL) in IBD. This single centre, two-arm, feasibility randomised controlled trial (RCT) aimed to assess the feasibility and initial estimates of potential efficacy of a CBT intervention for the management of IBD-fatigue. Feasibility, acceptability and initial estimates of potential efficacy outcomes were collected through self-report measures and semi-structured interviews. Participants were recruited from one tertiary referral centre. Intervention Group 1 received a CBT manual for fatigue, one 60-min and seven 30-min telephone sessions with a therapist over 8-weeks. Control Group 2 received a fatigue information sheet without therapist support. A nested qualitative study evaluated patients’ and therapists’ experiences, and IBD-healthcare professionals’ (HCPs) perceptions of the intervention. Eighty-nine participants were assessed for eligibility. Of these, 31 of the 70 eligible participants consented to participate (recruitment rate of 44%). Of the 15 participants randomised to the intervention group, 13 (87%) started it and 10 (77% of those who started) completed all 8 sessions. Follow-up questionnaires were completed by 22 (71%) participants at 3 months, 14 (45%) at 6 months and 12 (39%) at 12 months’ follow-up. The intervention was acceptable to participants and feasible for therapists to deliver. HCPs reported that the intervention would be applicable, but time, finance and training constraints limit its implementation. Initial estimates of potential efficacy with complete case analysis showed a reduction in fatigue and an increase in QoL at 3, 6 and 12 months post-randomisation. A full-scale effectiveness RCT testing CBT for IBD-fatigue is feasible and is potentially worthwhile with some changes to the protocol. However, given the small numbers, further pilot work is warranted before a full-scale RCT. Registration Trial ISRCTN 17917944, Registered 2 September 2016

    更新日期:2019-12-11
  • A single-site pilot implementation of a novel trauma training program for prehospital providers in a resource-limited setting
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-05
    Nee-Kofi Mould-Millman; Julia Dixon; Andrew Lamp; Shaheem de Vries; Brenda Beaty; Lani Finck; Kathryn Colborn; Kubendhren Moodley; Amanda Skenadore; Russell E. Glasgow; Edward P. Havranek; Vikhyat S. Bebarta; Adit A. Ginde

    Prehospital (ambulance) care can reduce morbidity and mortality from trauma. Yet, there is a dearth of effective evidence-based interventions and implementation strategies. Emergency Medical Services Traumatic Shock Care (EMS-TruShoC) is a novel bundle of five core evidence-based trauma care interventions. High-Efficiency EMS Training (HEET) is an innovative training and sensitization program conducted during clinical shifts in ambulances. We assess the feasibility of implementing EMS-TruShoC using the HEET strategy, and feasibility of assessing implementation and clinical outcomes. Findings will inform a main trial. We conducted a single-site, prospective cohort, multi-methods pilot implementation study in Western Cape EMS system of South Africa. Of the 120 providers at the study site, 12 were trainers and the remaining were eligible learners. Feasibility of implementation was guided by the RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) framework. Feasibility of assessing clinical outcomes was assessed using shock indices and clinical quality of care scores, collected via abstraction of patients’ prehospital trauma charts. Thresholds for progression to a main trial were developed a priori. The average of all implementation indices was 83% (standard deviation = 10.3). Reach of the HEET program was high, with 84% learners completing at least 75% of training modules. Comparing the proportion of learners attaining perfect scores in post- versus pre-implementation assessments, there was an 8-fold (52% vs. 6%) improvement in knowledge, 3-fold (39% vs. 12%) improvement in skills, and 2-fold (42% vs. 21%) increase in self-efficacy. Clinical outcomes data were successfully calculated—there were clinically significant improvements in shock indices and quality of prehospital trauma care in the post- versus pre-implementation phases. Adoption of HEET was good, evidenced by 83% of facilitator participation in trainings, and 100% of surveyed stakeholders indicating good programmatic fit for their organization. Stakeholders responded that HEET was a sustainable educational solution that aligned well with their organization. Implementation fidelity was very high; 90% of the HEET intervention and 77% of the implementation strategy were delivered as originally planned. Participants provided very positive feedback, and explained that on-the-job timing enhanced their participation. Maintenance was not relevant to assess in this pilot study. We successfully implemented the EMS-TruShoC educational intervention using the HEET training strategy in a single-site pilot study conducted in a low-resource international setting. All clinical outcomes were successfully calculated. Overall, this pilot study suggests high feasibility of our future, planned experimental trial.

    更新日期:2019-12-05
  • A pilot study of the duration of GP consultations in Ireland
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-12-01
    Tom Pierse; Luke Barry; Liam Glynn; Diarmuid Quinlan; Andrew Murphy; Ciaran O’Neill

    General practitioner (GP)-led primary care is the linchpin of health care in Ireland. Reflecting international trends, there are increasing concerns about the sustainability of the current Irish GP service due to an increasing workload. Objective data on the duration of GP consultations are currently not available in Ireland. The objective of this pilot study is to demonstrate how the duration of consultations can be collected, using readily available administrative data. Software was developed to extract the duration of GP consultations using the opening and closing of electronic patient records associated with a GP consultation. GP practices (N = 3) comprising 15 GPs were recruited from a university-affiliated research network. A retrospective analysis of GP consultations with patients with diabetes for the 9 years between 2010 and 2018 was used to assess the feasibility of using this system to measure the duration of consultations. The average duration of a consultation was 14.1 min for the 9 years spanning 2010 to 2018. Patients had an average time between consultations of 99 days. This pilot study confirms that an administrative data set can be utilised at negligible cost to monitor GP practice consultation workload over time. Our preliminary pilot data show that GP consultation durations among participating practices were longer than the 5–11.7 min reported in the UK and show an increase over the period. Clearly, a larger number of practices and patients are required to substantiate this finding.

    更新日期:2019-12-02
  • Aflatoxin exposure in children age 6–12 years: a study protocol of a randomized comparative cross-sectional study in Kenya, East Africa
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-29
    Ruth Nabwire Wangia; David Peter Githanga; Jia-Sheng Wang; Omu Aggrey Anzala

    Aflatoxins (AFs) are naturally occurring fungal metabolites produced by the Aspergilla species of fungi. The staple food grain, maize (Zea mays), is highly susceptible to AF contamination. In Kenya, contamination of maize supplies by AFs is a recognized public health problem which has resulted in over 600 human deaths. Human exposure to AFs can occur in utero, via breast milk, through weaning foods, and throughout an individual’s lifetime. Recent epidemiological studies have shown that exposure to AFs in early life through diet is a contributing factor to immune suppression, micronutrient deficiency, possible vaccine interference, and impaired growth in children. However, these results remain inconsistent and inconclusive due to lack of randomized controlled studies. A randomized school-based cross-sectional study was designed to study AF exposure levels and associated health effects in children between ages 6 and 12 years. Participants were recruited from primary schools within Siaya and Makueni Counties of Kenya, East Africa. The Joint Ethics Committee of the University of Nairobi and Kenyatta National Hospital in Kenya approved the research protocol and procedures for the study. Both parental consent and child assent were obtained before enrollment in the study. Parents were requested to provide household grain samples and fill out questionnaires detailing their sociodemographic information, household dietary patterns, farming practices, and knowledge of AF contamination. Blood samples were collected from children participants, and sera were prepared for analysis of AFB1-lysine which is one of the validated biomarkers for AF exposure. This protocol describes a school-based, cross-sectional study whose objective is to comparatively evaluate the role of AF exposure on adverse health outcomes in children. Specifically, effects of cumulative AF exposure on nutritional status, immune markers, and growth parameters will be assessed. This study is not a clinical trial, rather a cross-sectional study aimed at providing baseline data on AF exposures in children who live in presumably high versus low AF exposure regions. Results from the study can be used to design interventions and/or prospective cohort studies aimed at studying adverse health effects associated with cumulative AF exposure through diets. The study reference number is P741/12/2017 and registered with KNH-UoN Ethics and Research Committee.

    更新日期:2019-11-30
  • A feasibility cluster randomised controlled trial of a preschool obesity prevention intervention: ToyBox-Scotland
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-09
    Stephen Malden; John. J. Reilly; Ann-Marie Gibson; Farid Bardid; Carolyn Summerbell; Marieke De Craemer; Greet Cardon; Odysseas Androutsos; Yannis Manios; Adrienne Hughes

    High levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention. Six preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n = 3) or usual curriculum control group (n = 3). The intervention ran for 18 weeks from March–June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption. The preschool component of the intervention was implemented with high fidelity (64%), while the home component was implemented with low fidelity (41%). A cluster-level recruitment rate of 10% was achieved, and the individual-level recruitment rate was 18% (42/233 children, mean age 4.4 years; 17 girls). The attrition rate was 14%, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86%), while 19% of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23%. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up. Before progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention. ISRCTN12831555

    更新日期:2019-11-29
  • Teaching GenerationPMTO, an evidence-based parent intervention, in a university setting using a blended learning strategy
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-07-13
    Ana A. Baumann; Melanie M. Domenech Rodríguez; Elizabeth Wieling; J. Rubén Parra-Cardona; Laura A. Rains; Marion S. Forgatch

    Despite the large number of evidence-based practices (EBPs) ready for implementation, they are the exception in usual care, especially for ethnic minority patients, who may not have access to trained health professionals. Providing EBP training as part of a graduate curriculum could help build the pipeline of professionals to provide quality care. We conducted a before-after study to determine whether we could implement a blended learning strategy (BL; i.e., in vivo and online training) to teach an EBP in university settings. Feasibility in this pilot was operationalized as knowledge acquisition, satisfaction, fidelity, acceptability, and usability. Using GenerationPMTO as the EBP, our aim was to train graduate students enrolled in Psychology, Social Work, and Family Therapy programs in the EBP in one academic year. Two therapists from a community agency were also students in this pilot. A total of 13 students from five universities were trained in the intervention. Adaptations were made to the intervention and training strategy to optimize training fidelity. Focus groups were conducted with the students to capture their perspective about the training. Students demonstrated significant knowledge acquisition from baseline (Mean = 61.79, SD = 11.18) to training completion (Mean = 85.27, SD = 5.08, mean difference = − 23.48, 95% CI = − 29.62, − 17.34). They also reported satisfaction with the BL format, as measured by teaching evaluations at the end of the course. Instructors received acceptable fidelity scores (range of 7–9 in a 9-point scale). Qualitative findings from focus groups showed support for acceptability and usability of BL training. BL training in university settings can be conducted with fidelity when provided by appropriately trained instructors. BL that integrates EBP and adaptations may be uniquely applicable for training providers in low-resource and ethnically diverse settings. The BL enhanced knowledge of GenerationPMTO was acceptable and usable to students, and was delivered with high instructor fidelity to the training model.

    更新日期:2019-11-28
  • An investigation of methods to improve recall for the patient-reported outcome measurement in COPD patients: a pilot randomised control trial and feasibility study protocol
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-07-18
    Sheree M. S. Smith; Stephen Jan; Joseph Descallar; Guy B. Marks

    Patient-reported outcomes (PRO) are used to measure the effectiveness of interventions for management of chronic conditions such as chronic obstructive pulmonary disease. Many of these instruments require respondents to describe the change in their health status from baseline to a follow-up assessment and poor recall of previous health status often limits the usefulness and validity of these PRO measures. The use of technology has recently increased in PRO measurement. This study aims to mitigate the problems of poor recall by evaluating different strategies as a way to improve the validity of recall of health status among adults with COPD. A pilot randomised controlled trial of three strategies to improve patient recall will be tested in an acute care clinical environment. The first strategy is the use of tablet computer technology’s audio-visual facility, the second strategy is the provision of base line PRO responses prior to patients completing their follow-up questionnaires and third is standard practice of completing a questionnaire independently of previous responses. The feasibility of conducting this study in a busy clinical environment will be ascertained using the NIHR criteria for assessing feasibility. There is variability in a person’s ability to recall past events. With studies utilising patient-reported outcome measurement, it has become critically important to develop strategies and ways of supporting the patient to be more accurate recalling their health status. The adaptation of various technological features within mobile devices may provide an opportunity in clinical research studies to improve patient recall of their health status. ANZCTR12618001605280 .

    更新日期:2019-11-28
  • Cognitive behavioural therapy and mindfulness for relatives of missing persons: a pilot study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-07-20
    Lonneke I. M. Lenferink; Jos de Keijser; Ineke Wessel; Paul A. Boelen

    Relatives of long-term missing persons need to deal with uncertainties related to the disappearance. These uncertainties may give rise to ruminative thinking about the causes and consequences of the loss. Focusing on tolerating uncertainties in treatment of relatives of missing persons might foster recovery. Adding mindfulness to cognitive behavioural therapy might serve this aim. The feasibility and potential effectiveness of cognitive behavioural therapy with mindfulness were evaluated in a pilot study. We aimed to detect changes in symptom levels and mindfulness from pre-treatment to 1 week, 12 weeks, and 24 weeks post-treatment. Dutch adults who experienced the disappearance of a significant other more than 3 months earlier and scored above clinical thresholds for psychological distress were eligible to participate. Participants were recruited from January 2015 to July 2016. Participants in the immediate treatment group started treatment after 1 week after randomization, whereas waiting list controls started the treatment after 12 weeks of waiting. Data from self-report measures as well as clinical diagnostic interviews (tapping persistent complex bereavement disorder, major depressive disorder, and posttraumatic stress disorder) were gathered among 17 relatives of missing persons with elevated symptom levels. The response rate (31.7%) was low, and dropout rate (47.1%) high. Cognitive behavioural therapy with mindfulness coincided with changes in psychopathology levels (Hedges’ g 0.35–1.09) and mindfulness (Hedges’ g − 0.10–0.41). Participants completing the treatment were satisfied with treatment quality and reported high treatment compliance. Because of the limited research about effective treatments for relatives of missing persons and promising results of small and/or uncontrolled trials examining the effect of mindfulness-based treatment to target grief-related complaints, it seems valuable to continue investigating the effects of cognitive behavioural therapy with mindfulness on reducing post-loss psychopathology in future research. However, in order to increase the feasibility of future trials among relatives of missing persons, we recommend collaborating internationally and/or extending duration of recruitment phase, to maximize the sample size. The Netherlands National Trial Register, NTR4732 .

    更新日期:2019-11-28
  • A feasibility study to investigate post-operative oxygen consumption (POpOC) after colorectal surgery requiring bowel resection
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-07-22
    H. E. Taylor; K. Simons; C. Willmott; R. E. R. Smith; D. E. P. Bramley

    Oxygen consumption after surgery is increased in response to the tissue trauma sustained intra-operatively and the subsequent systemic inflammatory response that ensues. The cardio-respiratory system must match the tissue oxygen and metabolic requirements; otherwise, peri-operative complications may occur. Existing data is several decades old. The primary objective of this feasibility study was to determine the ease of recruiting participants and collecting relevant data to assess the extent and duration of increased oxygen consumption and post-operative complications after major abdominal surgery in contemporaneous times. One hundred patients scheduled for elective colorectal surgery requiring a bowel resection were screened to test specific feasibility criteria relating to ease of recruitment, duration of post-operative stay, ease of data collection, and drop-out rates. A calibrated metabolic cart was used to obtain unblinded pre-operative resting oxygen consumption recordings. The metabolic cart was then used to obtain post-operative oxygen consumption readings on days 1 to 5 as long as the participant remained as an inpatient. At the time of the oxygen consumption reading, a Post-Operative Morbidity Survey score (POMS) was calculated. Feasibility outcomes chosen a priori were that at least one participant would be recruited every 2 weeks from the pre-admission colorectal clinic, at least 10% of potential subjects screened would be enrolled, at least 80% of recruited participants would have a minimum post-operative stay of 2 nights, a minimum of 3 consecutive days of oxygen consumption data would be collected for each subject, at least 8 of 9 POMS score domains would be completed per participant per day and the drop-out rate would be no greater than 10%. We deemed that screening 100 patients would be sufficient to test our feasibility outcomes. Twelve participants completed the protocol. All pre-specified feasibility criteria were met. No increase in post-operative oxygen consumption was observed in this feasibility cohort. The protocol and experiences gained from this feasibility study could be used to plan a larger study to better define changes in post-operative oxygen consumption after major abdominal surgery utilizing current surgical techniques.

    更新日期:2019-11-28
  • A research protocol for a pilot, randomized controlled trial designed to examine the feasibility of a dyadic versus individual yoga program for family caregivers of glioma patients undergoing radiotherapy
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-07-25
    Kathrin Milbury; Jing Li; Shiao-Pei Weathers; Tina Shih; Smitha Malliaha; Yisheng Li; Lorenzo Cohen

    Although the diagnosis and treatment of a primary brain tumor present unique challenges to patients and their family caregivers, evidence-based supportive care interventions are generally lacking. The primary aim of this research protocol is to determine the feasibility of implementing a dyadic yoga (DY) versus a caregiver yoga (CY) intervention or a wait-list control (WLC) group using a randomized controlled trial design. Seventy-five glioma patients undergoing radiotherapy and their family caregivers are randomized to the DY, CY, or a WLC group. Patient-caregiver dyads in the DY group and caregivers in the CY group receive 15 sessions (45 min each) over the course of patients’ standard radiotherapy (6 weeks). Patients and caregivers in all groups complete baseline assessments of symptoms, quality of life (QOL), and health utilization outcomes prior to randomization. Follow-up assessments are performed 6 weeks and then again 3 months later. The primary outcome is feasibility (i.e., ≥ 50% of eligible dyads consent, ≥ 70% of enrolled dyads complete all assessments, and ≥ 50% of all practice sessions are attended). We will also perform primarily descriptive analyses of the self-reported outcomes (e.g., fatigue, overall QOL) and explore potential intervention moderators (e.g., performance status) to inform a larger future trial. This trial will provide important information regarding the feasibility of a dyadic versus a caregiver yoga intervention regarding symptom, QOL, and health utilization outcomes in glioma patients and their caregivers. ClinicalTrials.gov NCT02481349

    更新日期:2019-11-28
  • Regaining Confidence after Stroke (RCAS): a feasibility randomised controlled trial (RCT)
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-07-25
    Jane C. Horne; Kate E. Hooban; Nadina B. Lincoln; Pip A. Logan

    The Regaining Confidence after Stroke (RCAS) course was designed to facilitate adjustment for people with stroke discharged from rehabilitation. The aim of the trial was to evaluate the feasibility of conducting a randomised trial to compare a RCAS course with usual care. The rates feasibility of screening and recruitment, rates of consent and retention, acceptability of outcome measures and the acceptability and fidelity of the intervention were evaluated. Participants with stroke were recruited from hospital databases and community services and randomly assigned to the Regaining Confidence after Stroke (RCAS) course or usual care. The course comprised 11 weekly 2-h sessions with six–eight participants, delivered by two rehabilitation assistants. Carers were invited to attend three of the sessions. Sessions were video recorded. A six-item checklist was developed from the manual content. Each item was rated as met, partially met or not met. Fidelity was assumed if > 75% of the criteria were met. Outcomes were assessed three and six months after randomisation. Semi-structured interviews were conducted using open-ended questions to assess the acceptability of the intervention. Of 47 participants (mean age 66.9 years [SD 14.9]; 26 men), 22 were randomly allocated to the intervention and 25 to usual care. Participants attended a mean of 8.2 [SD 2.6] out of 11 sessions. Fidelity outcomes suggested that the content corresponded to the manual but further training of the therapist was needed. Interview findings indicated the intervention was acceptable and considered beneficial. At three months, 35 (78%) participants returned questionnaires and 30 (67%) at six months, but only 38(42%) were fully completed. The results support the feasibility of conducting a randomised trial to evaluate the effectiveness of a RCAS course compared to usual care. ISRCTN 36330958

    更新日期:2019-11-28
  • Patient-reported outcome measurement in community-acquired pneumonia: feasibility of routine application in an elderly hospitalized population
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-07-27
    Melanie A. Lloyd; Clarice Y. Tang; Emily J. Callander; Edward D. Janus; Amalia Karahalios; Elizabeth H. Skinner; Stephanie Lowe; Harin A. Karunajeewa

    Community-acquired pneumonia (CAP) is a leading cause of morbidity and mortality worldwide, but few studies have evaluated the feasibility of routine patient-reported outcome measures (PROMs) in this illness. This study investigates the feasibility and limitations of three credible PROM instruments in a representative hospitalized cohort to identify potential barriers to routine application. A sample of multimorbid hospitalized subjects meeting a standardized CAP definition was recruited. Demographic and clinical data of those able and unable to participate in PROM assessment were compared. The EQ-5D-5L, CAP-Sym 18 Questionnaire, and Late-Life Function and Disability Instrument (LLFDI) were administered (via face-to-face interview) at admission and discharge and (via phone interview or mail) at 30 and 90 days post-discharge. Feasibility measures included the proportion of individuals able to participate in assessment, attrition rates, data completeness, and instrument completion times. Scores at admission and 30 days post-discharge were examined for association with age. Of 82 subjects screened, 44 (54%) participated. Cognitive impairment (n = 12, 15%) commonly precluded participation. Seventeen (39%) participants were lost to follow-up by 90 days. Missing data at item level was negligible for all instruments, regardless of the mode of completion. Completion of the three instruments collectively in a face-to-face interview took a median of 17 min (IQ range 13–21) per participant. The burden of reported symptoms at admission was higher for younger participants aged 18–74 years (mean (standard deviation)) CAP-Sym 18 score at admission 34.2 (18.6) vs. 19.0 (11.3) for those aged ≥ 75 years. Routine application of PROMs can provide valuable information relating to multiple aspects of clinical recovery for individuals hospitalized with CAP. However, heterogeneous demographic characteristics and complex underlying health status introduce challenges to feasibility and interpretability of these instruments in this population. ClinicalTrials.gov, NCT02835040.

    更新日期:2019-11-28
  • HATRIC: a study of Pelargonium sidoides root extract EPs®7630 (Kaloba®) for the treatment of acute cough due to lower respiratory tract infection in adults—study protocol for a double blind, placebo-controlled randomised feasibility trial
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-07-31
    Amy Whitehead; Catherine Simpson; Merlin Willcox; Frances Webley; Alastair D. Hay; Chris Butler; Lily Yao; Emma Wrixon; Margaret Bell; Jennifer Bostock; Paul Little; Gareth Griffiths; Michael Moore

    Acute lower respiratory tract infection is a common acute infection managed in primary care. The current dominant management strategy in the UK is antibiotics, despite widespread publicity regarding antimicrobial resistance and evidence that the small benefits of antibiotics do not outweigh the harms. There is a need to address the rising problem of antibiotic resistance by providing credible alternative strategies, which reduce symptom burden. There is sufficient evidence to recommend the use of Pelargonium sidoides root extract in order to warrant undertaking an independent clinical trial. We propose a feasibility study to demonstrate our ability to recruit and retain patients and conduct a placebo-controlled trial of Pelargonium sidoides extract EPs®7630 in lower respiratory tract infection where pneumonia is not suspected. Both the tablet and liquid formulations will be included. The HATRIC trial is a double-blind randomised placebo-controlled feasibility study aiming to determine the potential to conduct a fully powered trial of Pelargonium sidoides root extract as an alternative to the inappropriate use of antibiotics for acute bronchitis in UK primary care. Primary care sites will be equally randomised to one of two formulation groups (tablet or liquid preparation). Additionally, within each site, patients will be evenly randomised to active or placebo treatment. Antibiotic consumption will be monitored during the trial, but the use of a delayed prescription strategy is encouraged. The target sample size for this study is 160 patients overall or 40 per arm, recruited from approximately 20 primary care sites. The analysis will be descriptive focusing on estimation with no formal comparison of groups taking place. If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding for a fully powered placebo-controlled trial of Pelargonium sidoides root extract for the treatment of lower respiratory tract infections in primary care. HATRIC was registered on the ISRCTN registry ( ISRCTN17672884 ) on 16 August 2018.

    更新日期:2019-11-28
  • Health literacy enhanced intervention for inner-city African Americans with uncontrolled diabetes: a pilot study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-08-08
    Hae-Ra Han; Manka Nkimbeng; Olayinka Ajomagberin; Kelli Grunstra; Phyllis Sharps; Susan Renda; Nisa Maruthur

    Disparities in diagnosis and control of type 2 diabetes mellitus are most evident in African Americans (AAs) with lower socioeconomic status. Health literacy is an important predictor of adequate self-management and control of diabetes. The purpose of this pilot study was to test the feasibility and preliminary efficacy of a health literacy-enhanced diabetes intervention, PLAN 4 Success (Prevention through Lifestyle intervention And Numeracy)-Diabetes, in inner-city, low-income AAs with uncontrolled type 2 diabetes. Nineteen of 30 participants who completed the baseline survey received the study intervention which consisted of 4-week health literacy training and disease knowledge education followed by two home visits and monthly phone counseling for over 24 weeks. A retention rate of 58% was achieved at 24 weeks. All participants who completed the follow-up assessment at 24 weeks reported high satisfaction with the intervention. Participation in the PLAN 4 Success-Diabetes was associated with improved glucose control and psychological outcomes at 12 weeks but the positive trend was attenuated at 24 weeks. The current intervention protocols were in general feasible and highly acceptable. The results support health literacy training as a promising component of interventions to promote glucose control among inner-city AAs. Some changes are suggested to optimize the protocols, before conducting a randomized controlled trial. Future interventions should consider addressing social determinants of health such as transportation as part of designing an intervention targeting low-income AAs with uncontrolled type 2 diabetes. ClinicalTrials.gov, NCT03925948 . Registered on 24 April 2019—retrospectively registered.

    更新日期:2019-11-28
  • “Strong Teeth”—a study protocol for an early-phase feasibility trial of a complex oral health intervention delivered by dental teams to parents of young children
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-08-13
    Kerina Tull; Kara A. Gray-Burrows; Amrit Bhatti; Jenny Owen; Lucy Rutter; Timothy Zoltie; Jayne Purdy; Erin Giles; Carron Paige; Morvin Patel; Zoe Marshman; Robert West; Sue Pavitt; Peter F. Day

    Dental attendance provides an important opportunity for dental teams to explore with parents the oral health behaviours they undertake for their young children (0–5 years old). For these discussions to be effective, dental professionals need to be skilled in behaviour change conversations. The current evidence suggests that dental teams need further support, training and resources in this area. Therefore, the University of Leeds and Oral-B (Procter & Gamble Company) have worked with the local community and dental professionals to co-develop “Strong Teeth” (an oral health intervention), which is delivered in a general dental practice setting by the whole dental team. The protocol for this early phase study will explore the feasibility and acceptability of the Strong Teeth intervention to parents and the dental team, as well as explore short-term changes in oral health behaviour. Forty parents (20 of children aged 0–2 years old, and 20 of children aged 3–5 years old) who are about to attend the dentist for their child’s regular dental check-up will be recruited to the study. Parents and children will be recruited from 4 to 8 different dental practices. In the home setting, consent and baseline oral health behaviour data will be collected. The researchers will ask parents questions about their child’s oral health behaviours, including toothbrushing and diet. Three different proxy objective measures of toothbrushing will be collected and compared with self-report measures of parental supervised toothbrushing (PSB). The parent and child will then attend their dental visit and receive the Strong Teeth intervention, delivered by the dental team. This intervention should take 5–15 min to be delivered, in addition to the routine dental check-up. Furthermore, children aged 0–2 years old will receive an Oral-B manual children’s toothbrush, and children aged 3–5 years old will receive an Oral-B electric rechargeable children’s toothbrush. At 2 weeks and 2–3 months following the Strong Teeth intervention, further self-report and objective measures will be collected in the parent/child’s home. This data will be supplemented with purposively sampled qualitative interviews with parents (approximately 3 months following the intervention) and dental team members (following delivery of the intervention). ISRCTN Register, ( ISRCTN10709150 )

    更新日期:2019-11-28
  • An electronic registry to improve adherence to active surveillance monitoring among men with prostate cancer at a safety-net hospital: protocol for a pilot study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-08-14
    Benjamin Cedars; Sarah Lisker; Hala T. Borno; Puneet Kamal; Benjamin Breyer; Urmimala Sarkar

    The evidence-based practice of active surveillance to monitor men with favorable-risk prostate cancer in lieu of initial definitive treatment is becoming more common. However, there are barriers to effective implementation, particularly in low-resource settings. Our goal is to assess the efficacy and feasibility of a health information technology registry for men on active surveillance at a safety-net hospital to ensure patients receive guideline-recommended care. We developed an electronic registry for urology clinic staff to monitor men on active surveillance. The health information technology tool was developed using the Systems Engineering Initiative for Patient Safety model and iteratively tailored to the needs of the clinic by engaging providers in a co-design process. We will enroll all men at Zuckerberg San Francisco General Hospital and Trauma Center who choose active surveillance as a treatment strategy. The primary outcomes to be assessed during this non-randomized, pragmatic evaluation are number of days delayed beyond recommended date of follow-up testing, the proportion of men who are lost to follow-up, the cancer stage at active treatment, and the feasibility and acceptability of the clinic-wide intervention with clinic staff. Secondary outcomes include appointment adherence within 30 days of the scheduled date. Use of a customized electronic approach for monitoring men on active surveillance could improve patient outcomes. It may help reduce the number of men lost to follow-up and improve adherence to timely follow-up testing. Evaluating the adoption and efficacy of a customized registry in a safety-net setting may also demonstrate feasibility for implementation in diverse clinical contexts. ClinicalTrials.gov identifier NCT03553732 , An Electronic Registry to Improve Adherence to Active Surveillance Monitoring at a Safety-net Hospital. Registered 11 June 2018.

    更新日期:2019-11-28
  • Exercise for advanced prostate cancer: a multicomponent, feasibility, trial protocol for men with metastatic castrate-resistant prostate cancer (EXACT)
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-08-16
    Malcolm Brown; Marie Murphy; Lauri McDermott; Helen McAneney; Joe M. O’Sullivan; Suneil Jain; Gillian Prue

    Men with metastatic castrate-resistant prostate cancer can experience an array of treatment-related side effects. Accumulating evidence suggests exercise may alleviate some of these adversities and assist in disease management. However, empirical evidence in advanced prostate cancer patients remains limited. The purpose of this study is to determine whether men with metastatic prostate cancer, who are ineligible for high-intensity exercise, can partake in a home-based, moderate-intensity exercise program and the impact of doing so on quality of life and physical fitness parameters. Thirty men with adenocarcinoma of the prostate and progressive systemic, metastatic disease will be recruited. Clinicians will screen patients against inclusion criteria to determine eligibility. All men enrolled will be prescribed a tailored, home-based, moderate-intensity exercise intervention consisting of aerobic and strengthening components for 12 weeks. Patients will receive supplementary education materials and weekly behavioural change consultations throughout the intervention. The primary outcome will be the feasibility of delivering such an intervention in men with metastatic disease. Secondary endpoints including skeletal events will be monitored for safety, as will the feasibility of patient-reported outcome measures and the sampling time points, generating data pertaining to completion rates and potential effect in future trials. General physical fitness will be assessed during these visits, using timed sit-to-stand testing and a 6-min walking test. Prior to each visit, objective physical activity levels will be captured for 7 days using an accelerometer, to determine the feasibility of this technology and the quality of data obtained. In parallel with the feasibility aspects of the trial, changes compared to baseline will be reported. Direct regular contact will also serve as a feedback loop, should any issues arise. This study has received ethical approval from the Office for Research Ethics Committees Northern Ireland. This study aims to determine the potential utility of a home-based exercise intervention in managing side effects associated with advanced prostate cancer and its treatment. This feasibility trial will inform the design and implementation of a larger randomised control trial to determine the efficacy of moderate aerobic and strengthening exercise as an adjuvant therapy in men with metastatic prostate cancer. Collecting such evidence provides further support for exercise in this paradigm and potential for its inclusion as a low-toxicity therapy in standard cancer care, in the longer term. ClinicalTrials.gov, NCT03658486 Trial sponsor: Queen’s University Belfast (Reference: B18/15). Contact: Dr. Paula Tighe, Research and Enterprise, Queen’s University Belfast. Telephone: 02890 973,296. Email: p.tighe@qub.ac.uk . The sponsor reviewed the protocol and ethical application prior to submission. Protocol issue: Version 1 (18th May 2018). Authors: MB, MM, SJ and GP.

    更新日期:2019-11-28
  • Feasibility and usefulness of a leadership intervention to implement evidence-based falls prevention practices in residential care in Canada
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-08-19
    Wendy Gifford; Krystina B. Lewis; Ann Catrine Eldh; Val Fiset; Tara Abdul-Fatah; Anna Cristina Aberg; Kednapa Thavorn; Ian D. Graham; Lars Wallin

    Leadership is critical to supporting and facilitating the implementation of evidence-based practices in health care. Yet, little is known about how to develop leadership capacity for this purpose. The aims of this study were to explore the (1) feasibility of delivering a leadership intervention to promote implementation, (2) usefulness of the leadership intervention, and (3) participants’ engagement in leadership to implement evidence-based fall prevention practices in Canadian residential care. We conducted a mixed-method before-and-after feasibility study on two units in a Canadian residential care facility. The leadership intervention was based on the Ottawa model of implementation leadership (O-MILe) and consisted of two workshops and two individualized coaching sessions over 3 months to develop leadership capacity for implementing evidence-based fall prevention practices. Participants (n = 10) included both formal (e.g., managers) and informal (e.g., nurses and care aids leaders). Outcome measures were parameters of feasibility (e.g., number of eligible candidates who attended the workshops and coaching sessions) and usefulness of the leadership intervention (e.g., ratings, suggested modifications). We conducted semi-structured interviews guided by the Implementation Leadership Scale (ILS), a validated measure of 12-item in four subcategories (proactive, supportive, knowledgeable, and perseverant), to explore the leadership behaviors that participants used to implement fall prevention practices. We repeated the ILS in a focus group meeting to understand the collective leadership behaviors used by the intervention team. Barriers and facilitators to leading implementation were also explored. Delivery of the leadership intervention was feasible. All participants (n = 10) attended the workshops and eight participated in at least one coaching session. Workshops and coaching were rated useful (≥ 3 on a 0–4 Likert scale where 4 = highly useful) by 71% and 86% of participants, respectively. Participants rated the O-MILe subcategories of supportive and perseverant leadership highest for individual leadership, whereas supportive and knowledgeable leadership were rated highest for team leadership. The leadership intervention was feasible to deliver, deemed useful by participants, and fostered engagement in implementation leadership activities. Study findings highlight the complexity of developing implementation leadership and modifications required to optimize impact. Future trials are now required to test the effectiveness of the leadership intervention on developing leadership for implementing evidence-based practices.

    更新日期:2019-11-28
  • Brief Engagement and Acceptance Coaching for Community and Hospice Settings (the BEACHeS Study): Protocol for the development and pilot testing of an evidence-based psychological intervention to enhance wellbeing and aid transition into palliative care
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-08-20
    Nicholas J. Hulbert-Williams; Sabrina Norwood; David Gillanders; Anne Finucane; Juliet Spiller; Jenny Strachan; Sue Millington; Brooke Swash

    Cancer affects millions of individuals globally, with a mortality rate of over eight million people annually. Although palliative care is often provided outside of specialist services, many people require, at some point in their illness journey, support from specialist palliative care services, for example, those provided in hospice settings. This transition can be a time of uncertainty and fear, and there is a need for effective interventions to meet the psychological and supportive care needs of people with cancer that cannot be cured. Whilst Acceptance and Commitment Therapy (ACT) has been shown to be effective across diverse health problems, robust evidence for its effectiveness in palliative cancer populations is not extensive. This mixed-methods study uses a single-case experimental design with embedded qualitative interviews to pilot test a novel intervention for this patient group. Between 14 and 20 patients will be recruited from two hospices in England and Scotland. Participants will receive five face-to-face manualised sessions with a psychological therapist. Sessions are structured around teaching core ACT skills (openness, awareness and engagement) as a way to deal effectively with challenges of transition into specialist palliative care services. Outcome measures include cancer-specific quality of life (primary outcome) and distress (secondary outcome), which are assessed alongside measures of psychological flexibility. Daily diary outcome assessments will be taken for key measures, alongside more detailed weekly self-report, through baseline, intervention and 1-month follow-up phases. After follow-up, participants will be invited to take part in a qualitative interview to understand their experience of taking part and acceptability and perceived effectiveness of the intervention and its components. This study is the first investigation of using ACT with terminally ill patients at the beginning of their transition into palliative treatment. Using in-depth single-case approaches, we will refine and manualise intervention content by the close of the study for use in follow-up research trials. Our long-term goal is then to test the intervention as delivered by non-psychologist specialist palliative care practitioners thus broadening the potential relevance of the approach. Open Science Framework, 46033 . Registered 19 April 2018.

    更新日期:2019-11-28
  • Heavy-slow resistance training in addition to an ultrasound-guided corticosteroid injection for individuals with plantar fasciopathy: a feasibility study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-08-24
    Henrik Riel; Jens Lykkegaard Olesen; Martin Bach Jensen; Bill Vicenzino; Michael Skovdal Rathleff

    Plantar fasciopathy, characterised by plantar heel pain, affects one in ten in a lifetime. Heavy-slow resistance training (HSR) is an emerging treatment, but it often takes considerable time before the effect starts to manifest. Combining HSR with a corticosteroid injection (known for its short-term pain relief) could potentially improve outcomes in both short and long term. As this combination is yet to be investigated, we aimed to evaluate the feasibility of combining HSR with a corticosteroid injection for individuals with plantar fasciopathy before investigating the efficacy in a clinical trial. We recruited 20 participants with plantar fasciopathy for this prospectively registered feasibility study ( ClinicalTrials.gov : NCT03535896). Participants received an ultrasound-guided injection and performed heel raises on a step every second day for 8 weeks. To assess participant acceptability of the combined interventions and exercise compliance, we used a 7-point Likert scale dichotomised to “unacceptable” (categories 1–2) or “acceptable” (categories 3–7) and training diaries. Greater than or equal to 10/20 had to rate the combination “acceptable”, ≥ 15/20 had to perform ≥ 20 training sessions, and ≥ 15/20 had to start exercising ≤ 7 days after injection to confirm feasibility. Eighteen out of 20 rated the combination acceptable. Five training diaries could not be retrieved. Ten out of 15 participants performed ≥ 20 training sessions, and 15/15 started exercising ≤ 7 days after injection. Based on participant acceptability and time to exercise start, combining HSR with corticosteroid injection is feasible and the efficacy should be investigated in a future trial. Due to loss of 5/20 training diaries, firm conclusions regarding exercise compliance could not be drawn. ClinicalTrials.gov , NCT03535896

    更新日期:2019-11-28
  • GAPcare: the Geriatric Acute and Post-acute Fall Prevention Intervention—a pilot investigation of an emergency department-based fall prevention program for community-dwelling older adults
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-08-27
    Elizabeth M. Goldberg; Linda Resnik; Sarah J. Marks; Roland C. Merchant

    Falls are the leading cause of fatal and non-fatal injuries among older adults. Older emergency department (ED) patients who present for evaluations after falls have a 30% higher risk of falling again in the subsequent 6 months than age-matched controls. Although EDs frequently evaluate older adults after their falls, the typical evaluation consists of an injury assessment alone. As such, an opportunity is lost to assess and address the potential causes of falls in this vulnerable population. In this manuscript, we present a multidisciplinary fall prevention protocol for a pilot study of older adult ED patients who recently sustained a fall (GAPcare: the Geriatric Acute and Post-acute Fall Prevention Intervention). GAPcare is a randomized single-blinded pilot study. Participants in GAPcare are 120 older adults (≥ 65 years old) who present to 1 of 2 academic US EDs after a fall. We randomly assign participants 1:1 to an intervention or a usual care (control) arm. In the intervention arm, the patient’s ED physician, a pharmacist, and a physical therapist (PT) collaborate to identify and address any risk factors that may have contributed to the fall. Intervention arm participants and their caregivers return home with a medication-related action plan to taper or stop potentially inappropriate medications and to address polypharmacy and a PT assessment and plan. Participants in the usual care arm receive standard assessments and care in the ED and a home safety brochure. Participants in both study arms complete fall calendars for 6 months to document the number of falls and healthcare visits during follow-up. The primary outcome is feasibility of the GAPcare fall prevention intervention (number and proportion of screened participants who are eligible, recruited, and retained; impact on ED length of stay), while the secondary outcome is to estimate its initial efficacy. The GAPcare-ED fall prevention intervention has the potential to promote older adult-sensitive care for millions of Americans presenting to EDs after falls and establish a protocol for a future large-scale randomized controlled trial on this topic. ClinicalTrials.gov, NCT03360305 . Trial registration date: December 4, 2017. Protocol version: 1

    更新日期:2019-11-28
  • Should treatment effects be estimated in pilot and feasibility studies?
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-08-28
    Julius Sim

    Feasibility studies and external pilot studies are used increasingly to inform planning decisions related to a definitive randomized controlled trial. These studies can provide information on process measures, such as consent rates, treatment fidelity and compliance, and methods of outcome measurement. Additionally, they can provide initial parameter estimates for a sample size calculation, such as a standard deviation or the ‘success’ rate for a binary outcome in the control group. However, the issue of estimating treatment effects in pilot or feasibility studies is controversial. Between-group estimates of treatment effect from pilot studies are sometimes used to calculate the sample size for a main trial, alongside estimated standard deviations. However, whilst estimating a standard deviation is an empirical matter, a targeted treatment effect should be established in terms of clinical judgement, as a minimum important difference (MID), not through analysis of pilot data. Secondly, between-group effects measured in pilot studies are sometimes used to indicate the magnitude of an effect that might be obtained in a main trial, and a decision on progression made with reference to the associated confidence interval. Such estimates will be imprecise in typically small pilot studies and therefore do not allow a robust decision on a main trial; both a decision to proceed and a decision not to proceed may be made too readily. Thirdly, a within-group change might be estimated from a pilot or a feasibility study in a desire to assess the potential efficacy of a novel intervention prior to testing it in a main trial, but again such estimates are liable to be imprecise and do not allow sound causal inferences. Treatment effects calculated from pilot or feasibility studies should not be the basis of a sample size calculation for a main trial, as the MID to be detected should be based primarily on clinical judgement rather than statistics. Deciding on progression to a main trial based on these treatment effects is also misguided, as they will normally be imprecise, and may be biased if the pilot or feasibility study is unrepresentative of the main trial.

    更新日期:2019-11-28
  • Rethinking Strategies for Positive Newborn Screening Result (NBS+) Delivery (ReSPoND): a process evaluation of co-designing interventions to minimise impact on parental emotional well-being and stress
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-09-04
    Jane Chudleigh; Jim Bonham; Mandy Bryon; Jill Francis; Louise Moody; Steve Morris; Alan Simpson; Fiona Ulph; Kevin Southern

    Newborn blood spot (NBS) screening seeks to prevent ill health, disability and death through early diagnosis and effective intervention. Each year, around 10,000 parents of babies born in England are given a positive NBS result indicating their child may be affected or carriers of one of the nine conditions currently screened for. Despite guidance, these results are inconsistently delivered to parents across geographical regions. There is evidence that many parents are dissatisfied with how NBS results are communicated to them and that poor communication practices can lead to various negative sequelae. The purpose of this study is to co-design, implement and undertake a process evaluation of new, co-designed interventions to improve delivery of initial positive NBS results to parents. This mixed-methods study will use four phases with defined outputs. Family Systems Theory will form the theoretical basis for the study. The principles and methods of experience-based co-design will underpin intervention development. Normalisation Process Theory will underpin the process evaluation of the interventions co-designed to improve the delivery of positive NBS results to parents. An economic analysis will determine resource use and costs of current practice and of implementing the new co-designed interventions. The nominal group technique will be used to inform the selection of suitable outcome measures for a future evaluation study. The main output of the proposed study will be co-designed interventions for initial communication of positive NBS results to parents ready to be evaluated in a definitive evaluation study. The interventions, co-designed with parents, will help to minimise potential negative sequelae associated with poor communication practices by considering parental and staff experiences as well as healthcare challenges such as finite resources. In addition, information about indicative costs associated with different communication strategies will be determined. It is anticipated it may also be possible to extrapolate principles of good communication practices from the present study for the delivery of bad news to parents for children newly diagnosed with other conditions including cancer and other chronic conditions such as diabetes or epilepsy. ISRCTN 15330120 date of registration 17/01/2018

    更新日期:2019-11-28
  • Key recruitment and retention strategies for a pilot web-based intervention to decrease obesity risk among minority youth
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-09-05
    Grisselle DeFrank; Sarina Singh; Katrina F. Mateo; Laura Harrison; Alyson Rosenthal; Allison Gorman; May May Leung

    Interactive Nutrition Comics for Urban Minority Youth (Intervention INC) is an innovative, web-based interactive comic tool for dietary self-management, which aims to decrease obesity risk among urban minority preadolescents. The feasibility and acceptability of Intervention INC was assessed by implementing a two-group randomized pilot study. To date, intervention studies have typically faced various barriers in recruiting and retaining study participants. The purpose of this paper is to describe recruitment and retention activities from this study and in particular, discuss challenges faced, strategies implemented, and lessons learned. Black/AA and Latino children (ages 9–12 years) and their parent/guardian were recruited from East Harlem/Harlem, New York. Recruitment strategies included flyering in the community, having a convenient study location, providing participation incentives, and partnering with community/school-based organizations. Potential participants were screened for eligibility; enrollees completed online surveys and interviews at baseline (T1), intervention midpoint (T2), intervention end (T3), and 3-months post-intervention (T4). Retention strategies included flexible scheduling, reminder calls/texts, incremental compensation, and consistent study staff. Eighty-nine enrolled dyads completed a T1 visit (August to November 2017) and were randomized to the experimental (E, n = 45) or comparison (C, n = 44) group. Enrolled dyads learned about the study through community events (39%), community flyering (34%), friend/referral (15%), or a community clinic partner (12%). T1 child demographics were mean age = 10.4 ± 1.0 years, 61% female, 62% Black and 42% Latino, and 51% overweight/obese; parent demographics were mean age = 30.8 ± 8.9 years, 94% female, and 55% Black and 45% Latino. Survey completion rates by dyad were high throughout the study: T2, 87%; T3, 89%; and T4, 84%. Average data collection per session was 65 min. Parents at T4 (n = 76) felt they received enough study information (97%) and that their questions were answered properly (80%). Eighty-one percent of children at T4 (n = 75) were very satisfied/extremely satisfied with how study staff communicated and interacted with them. Effective recruitment strategies consisted of community events and flyering, while a variety of retention strategies were also used to successfully engage urban Black/AA and Latino families in this study. Though our findings are limited to only Latino and Black families in low-income neighborhoods, we have identified successful strategies for this specific high-risk population and potentially similar others. ClinicalTrials.gov, NCT03165474 , registered 15 May 2017

    更新日期:2019-11-28
  • Clinical comparative effectiveness of acupuncture versus manual therapy treatment of lateral epicondylitis: feasibility randomized clinical trial
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-09-07
    Katrine Bostrøm; Sverre Mæhlum; Milada Cvancarova Småstuen; Kjersti Storheim

    Lateral epicondylitis (LE) is a challenging condition for clinicians, and research has yet not proven the superiority of one specific treatment approach. However, manual therapy (elbow mobilization) in addition to eccentric exercise has been found to be superior to exercise alone. As well, acupuncture is effective in short-term pain relief when compared with sham treatment, but there is little knowledge on the comparative effectiveness of manual therapy and acupuncture treatment of LE in terms of pain relief. The primary objective of this pilot trial was to assess the feasibility (retention and adherence rates) of performing a randomized controlled trial (RCT) to explore the clinical effectiveness of acupuncture and manual therapy treatment of LE. This pilot trial took place in an outpatient interdisciplinary institute of sports medicine and rehabilitation in Oslo, Norway. Thirty-six adults with clinically diagnosed LE were randomly allocated into one of three groups: eccentric exercise alone, eccentric exercise plus acupuncture, or eccentric exercise plus manual therapy for a 12-week treatment period. Primary outcomes were patient retention and adherence rates. Secondary outcomes included patient-reported pain (NRS), level of disability (Quick-DASH), and participant’s satisfaction with treatment and global perceived effect. Nine (69%) patients in the acupuncture group completed the 1-year follow-up, compared to eight (67%) in the manual therapy group and five (45%) in exercise alone. Our goal was to demonstrate a retention rate above 80% to avoid serious threats to validity, but the result was lower than expected. The majority of participants (64%) in both treatment groups received only three-treatment sessions; the reasons included non-attendance or recovery from pain. Secondary outcomes support the rationale for conduction of an RCT. There were no adverse advents related to study participation. Based on differences in pain relief between groups, patient retention, and adherence rates, an RCT seems to be feasible to assess treatment effectiveness more precisely. In a future definitive trial, greater dropout may be reduced by maintaining contact with the participants in the exercise alone group throughout the intervention, and objective assessments might be considered. ClinicalTrials.gov, NCT02321696

    更新日期:2019-11-28
  • Pilot test of an educational intervention to improve self-management of diabetes in persons living with HIV
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-09-07
    Julie Zuñiga; Alexandra A. García; Luisa Silva; Jung-Min Park; Yuri Barrera

    People living with a diagnosis of HIV (PLWH) and type 2 diabetes (T2DM) can experience a synergistic negative impact on their vascular and immune systems if their conditions are poorly controlled. The purpose of this study was to adapt a community-based diabetes self-management intervention for people living with HIV and test the feasibility of administering the intervention with PLWH+T2DM who are low-income, predominantly minority, vulnerable population. The intervention was 12 weeks long with 6 h of educational instruction followed by 6 weekly support telephone calls to reinforce training and problem solve. The study used a one-group pretest–posttest design. Participants were a convenience sample of 25 adults diagnosed with HIV + T2DM. Diabetes knowledge, HIV knowledge, and self-management skills were measured. Analyses comprised descriptive statistics and correlations. Participants completed an average of 2.7 of 6 h of instruction and an average of 3 of 6 possible telephone calls. There was a 34% increase in diabetes self-management skills from pretest to posttest, but there were no changes in knowledge about HIV or diabetes. Based on this pilot study, next steps will include a multi-modal educational intervention, with in-person, at-home, and teleconference components. Blood sample collection procedure will be coordinated with study visits to decrease participants’ burden, and the updated diabetes knowledge instrument with a higher reported internal consistency will be used.

    更新日期:2019-11-28
  • Effectiveness of text messages for decreasing inactive behaviour in patients with knee osteoarthritis: a pilot randomised controlled study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-09-07
    Cecilie Bartholdy; Henning Bliddal; Marius Henriksen

    One of the big contributors to physical inactivity in the elderly population is osteoarthritis (OA) of the knee. Digital motivation seems to have a positive effect on individual physical inactivity level, but limited evidence exists on the effects of digital motivation on patients with knee OA. To investigate if motivational text messages reduce time spent physically inactive in patients with knee OA. This study was designed as an unblinded pilot randomised controlled trial, randomising participants equally (1:1) to an intervention group (motivational text messages) or control group (no intervention). Participants were recruited from six physical therapy clinics in Denmark. Inclusion criteria were age ≥ 18, diagnosed with knee OA, owner of a smartphone or tablet, and participating or commencing participation in the GLA:D® program. The primary outcome was time spent physically inactive, measured with a tri-axial accelerometer mounted on the lateral side of the thigh. Data on OA symptoms were obtained using the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire. A total of 49 participants were screened, and 38 participants were included and randomised to either the intervention group (n = 19) or the control group (n = 19). No statistically significant difference between the two groups was found in average change of time spent physically inactive (mean difference 13.2 min/day [95% CI − 41.0 to 67.3]; P = 0.63), time spent standing (mean difference 3.0 min/day [95% CI − 22.7 to 28.7]; P = 0.81), or time spent moving (mean difference − 20.4 min/day [95% CI − 63.0 to 22.3]; P = 0.34) nor was there any difference in change between the two groups on KOOS. Motivational text messages have seemed to have no effect on overall time spent physically inactive. clinicaltrials.gov, NCT03339011 . Registered 9 November 2017

    更新日期:2019-11-28
  • Home management of lower limb lymphoedema with an intermittent pneumatic compression device: a feasibility study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-09-30
    Nyree Dunn; E. Mark Williams; Michelle Fishbourne; Gina Dolan; Jane H. Davies

    Lymphoedema is a chronic condition that causes swelling in the body tissues. Presently, there is no cure for lymphoedema; instead, current treatment is aimed at lifelong management to help control symptoms. Intermittent pneumatic compression (IPC) therapy can be considered as an adjunct to standard lymphoedema care; however, research regarding the efficacy of this treatment modality is limited. Twenty participants were recruited from an outpatient lymphoedema clinic (South Wales, UK) to a feasibility randomised control trial designed to evaluate the efficacy of an IPC device (LymphAssist, Huntleigh Healthcare) in reducing lower limb volume. The primary objective was to assess feasibility in terms of (1) study feasibility, including recruitment, retention and assessment of outcome measures, and (2) intervention feasibility, including intervention fidelity and acceptability to participants. Participants were randomly assigned to a control group (n = 10) or intervention group (n = 10). The control group received their standard lymphoedema care only for a 6-month period, whereas the intervention group received their standard lymphoedema care plus an IPC device to use for 6 months. A bilateral lower limb assessment and quality of life survey were undertaken at baseline and 3- and 6-month time points. The study recruited to target within the planned time frame with a retention rate of 80%. Issues relating to potential recruitment bias and study attrition were identified and possible solutions explored. In addition, supplementary primary outcome measures that are important to the study population were identified and will be incorporated into the design of future studies. This feasibility study identified that a larger randomised controlled trial investigating the efficacy of home use IPC devices is feasible with modifications to the study protocol. This trial is registered with clinicaltrials.gov ( NCT03825263 ).

    更新日期:2019-11-28
  • Guidelines for reporting non-randomised pilot and feasibility studies
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-10-06
    Gillian A. Lancaster; Lehana Thabane

    As the number of submissions to Pilot and Feasibility Studies increases, there is a need for good quality reporting guidelines to help researchers tailor their reports in a way that is consistent and helpful to other readers. The publication in 2016 of the CONSORT extension to pilot and feasibility trials filled a much-needed gap, but there still remains some uncertainty as to how to report pilot and feasibility studies that are not randomised. This editorial aims to provide some general guidance on how to report the most common types of non-randomised pilot and feasibility studies that are submitted to the journal. We recommend using the CONSORT extension to pilot and feasibility trials as the main reference document—it includes detailed elaboration and explanation of each item, and in most cases, simple adaptation, or non-use of items that are not applicable, will suffice. Several checklists found on the Equator website may provide helpful supplementary guidance, when used alongside the CONSORT extension, and we give some examples.

    更新日期:2019-11-28
  • Adapting and implementing Caring Contacts in a Department of Veterans Affairs emergency department: a pilot study protocol
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-10-10
    Sara J. Landes; JoAnn E. Kirchner; John P. Areno; Mark A. Reger; Traci H. Abraham; Jeffery A. Pitcock; Mary J. Bollinger; Katherine Anne Comtois

    Suicide among veterans is a problem nationally, and suicide prevention remains a high priority for the Department of Veterans Affairs (VA). Focusing suicide prevention initiatives in the emergency department setting provides reach to veterans who may not be seen in mental health and targets a critical risk period, transitions in care following discharge. Caring Contacts is a simple and efficacious suicide prevention approach that could be used to target this risk period. The purpose of this study is to (1) adapt Caring Contacts for use in a VA emergency department, (2) conduct a pilot program at a single VA emergency department, and (3) create an implementation toolkit to facilitate spread of Caring Contacts to other VA facilities. This project includes planning activities and a pilot at a VA emergency department. Planning activities will include determining available data sources, determining logistics for identifying and sending Caring Contacts, and creating an implementation toolkit. We will conduct qualitative interviews with emergency department staff and other key stakeholders to gather data on what is needed to adapt and implement Caring Contacts in a VA emergency department setting and possible barriers to and facilitators of implementation. An advisory board of key stakeholders in the facility will be created. Qualitative findings from interviews will be presented to the advisory board for discussion, and the board will use these data to inform decision making regarding implementation of the pilot. Once the pilot is underway, the advisory board will convene again to discuss ongoing progress and determine if any changes are needed to the implementation of the Caring Contacts intervention. Findings from the current project will inform future scale-up and spread of this innovation to other VA medical center emergency departments across the network and other networks. The current pilot will adapt Caring Contacts, create an implementation toolkit and implementation guide, evaluate the feasibility of gathering outcome measures, and provide information about what is needed to implement this evidence-based suicide prevention intervention in a VA emergency department.

    更新日期:2019-11-28
  • A pilot study of the S-MAP (Solutions for Medications Adherence Problems) intervention for older adults prescribed polypharmacy in primary care: study protocol
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-10-22
    D. E. Patton; J. J. Francis; E. Clark; F. Smith; C. A. Cadogan; C. Ryan; C. M. Hughes

    Adhering to multiple medications as prescribed is challenging for older patients (aged ≥ 65 years) and a difficult behaviour to improve. Previous interventions designed to address this have been largely complex in nature but have shown limited effectiveness and have rarely used theory in their design. It has been recognised that theory (‘a systematic way of understanding events or situations’) can guide intervention development and help researchers better understand how complex adherence interventions work. This pilot study aims to test a novel community pharmacy-based intervention that has been systematically developed using the Theoretical Domains Framework (12-domain version) of behaviour change. As part of a non-randomised pilot study, pharmacists in 12 community pharmacies across Northern Ireland (n = 6) and London, England (n = 6), will be trained to deliver the intervention to older patients who are prescribed ≥ 4 regular medicines and are non-adherent (self-reported). Ten patients will be recruited per pharmacy (n = 120) and offered up to four tailored one-to-one sessions, in the pharmacy or via telephone depending on their adherence, over a 3–4-month period. Guided by an electronic application (app) on iPads, the intervention content will be tailored to each patient’s underlying reasons for non-adherence and mapped to the most appropriate solutions using established behaviour change techniques. This study will assess the feasibility of collecting data on the primary outcome of medication adherence (self-report and dispensing data) and secondary outcomes (health-related quality of life and unplanned hospitalisations). An embedded process evaluation will assess training fidelity for pharmacy staff, intervention fidelity, acceptability to patients and pharmacists and the intervention’s mechanism of action. Process evaluation data will include audio-recordings of training workshops, intervention sessions, feedback interviews and patient surveys. Analysis will be largely descriptive. Using pre-defined progression criteria, the findings from this pilot study will guide the decision whether to proceed to a cluster randomised controlled trial to test the effectiveness of the S-MAP intervention in comparison to usual care in community pharmacies. The study will also explore how the intervention components may work to bring about change in older patients’ adherence behaviour and guide further refinement of the intervention and study procedures. This study is registered at ISRCTN: https://doi.org/10.1186/ISRCTN73831533

    更新日期:2019-11-28
  • Protocol for a two-arm feasibility RCT to support postnatal maternal weight management and positive lifestyle behaviour in women from an ethnically diverse inner city population: the SWAN feasibility trial
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-10-23
    Debra Bick; Cath Taylor; Amanda Avery; Vanita Bhavnani; Victoria Craig; Andy Healey; Nina Khazaezadeh; Sarah McMullen; Bimpe Oki; Eugene Oteng-Ntim; Sheila O’Connor; Lucilla Poston; Paul Seed; Sarah Roberts; Michael Ussher

    A high BMI during and after pregnancy is linked to poor pregnancy outcomes and contributes to long-term maternal obesity, hypertension, and diabetes. Evidence of feasible, effective postnatal interventions is lacking. This randomised controlled trial will assess the feasibility of conducting a future definitive trial to determine effectiveness and cost-effectiveness of lifestyle information and access to Slimming World® (Alfreton, UK) groups for 12 weeks commencing from 8 to 16 weeks postnatally, in relation to supporting longer-term postnatal weight management in women in an ethnically diverse inner city population. Women will be recruited from one maternity unit in London. To be eligible, women will be overweight (BMI 25–29.9 kg/m2) or obese (BMI ≥ 30 kg/m2) as identified at their first antenatal contact, or have a normal BMI (18.5–24.9 kg/m2) at booking but gain excessive gestational weight as assessed at 36 weeks gestation. Women will be aged 18 and over, can speak and read English, expecting a single baby, and will not have accessed weight management groups in this pregnancy. Women will be randomly allocated to standard care plus lifestyle information and access to Slimming World® (Alfreton, UK) groups or standard care only. A sample of 130 women is required. Feasibility trial objectives reflect those considered most important inform a decision about undertaking a definitive future trial. These include estimation of impact of lifestyle information and postnatal access to Slimming World® (Alfreton, UK) on maternal weight change between antenatal booking weight and weight at 12 months postbirth, recruitment rate and time to recruitment, retention rate, influence of lifestyle information and Slimming World® (Alfreton, UK) groups on weight management, diet, physical activity, breastfeeding, smoking cessation, alcohol intake, physical and mental health, infant health, and health-related quality of life 6 and 12 months postnatally. An embedded process evaluation will assess acceptability of study processes and procedures to women. London–Camberwell St Giles Research Ethics Committee, reference: 16/LO/1422. Outcomes will be disseminated in peer-reviewed journals and presentations at national and international conferences. Trial registration number: ISRCTN 39186148 . Protocol version number: v7, 13 August 17. Trial sponsor: King’s College London.

    更新日期:2019-11-28
  • Pilot randomized controlled trial of a complex intervention for diabetes self-management supported by volunteers, technology, and interprofessional primary health care teams
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-10-27
    Gina Agarwal; Jessica Gaber; Julie Richardson; Dee Mangin; Jenny Ploeg; Ruta Valaitis; Graham J. Reid; Larkin Lamarche; Fiona Parascandalo; Dena Javadi; Daria O’Reilly; Lisa Dolovich

    Most health care for people with diabetes occurs in family practice, yet balancing the time and resources to help these patients can be difficult. An intervention empowering patients, leveraging community resources, and assisting self-management could benefit patients and providers. Thus, the feasibility and potential for effectiveness of “Health Teams Advancing Patient Experience, Strengthening Quality through Health Connectors for Diabetes Management” (Health TAPESTRY-HC-DM) as an approach supporting diabetes self-management was explored to inform development of a future large-scale trial. Four-month pilot randomized controlled trial (RCT), sequential explanatory qualitative component. Participants—patients of an interprofessional primary care team—were over age 18 years, diagnosed with diabetes and hypertension, and had Internet access and one of the following: uncontrolled HbA1c, recent diabetes diagnosis, end-stage/secondary organ damage, or provider referral. The Health TAPESTRY-HC-DM intervention focused on patient health goals/needs, integrating community volunteers, eHealth technologies, interprofessional primary care teams, and system navigation. Pilot outcomes included process measures (recruitment, retention, program participation), perceived program feasibility, benefits and areas for improvement, and risks or safety issues. The primary trial outcome was self-efficacy for managing diabetes. There were a number of secondary trial outcomes. Of 425 eligible patients invited, 50 signed consent (11.8%) and 35 completed the program (15 intervention, 20 control). Volunteers (n = 20) met 28 clients in 234 client encounters (home visits, phone calls, electronic messages); 27 reports were sent to the interprofessional team. At 4 months, controlling for baseline, most outcomes were better in the intervention compared to control group; physical activity notably better. The most common goal domains set were physical activity, diet/nutrition, and social connection. Clients felt the biggest impact was motivation toward goal achievement. They struggled with some of the technologies. Several participants perceived that the program was not a good fit, mostly those that felt they were already well-managing their diabetes. Health TAPESTRY-HC-DM was feasible; a large-scale randomized controlled trial seems possible. However, further attention needs to be paid to improving recruitment and retention. The intervention was well received, though was a better fit for some participants than others. ClinicalTrials.gov, NCT02715791 . Registered 22 March 2016—retrospectively registered.

    更新日期:2019-11-28
  • A randomised controlled feasibility trial and qualitative evaluation of an early years language development intervention: study protocol of the ‘outcomes of Talking Together evaluation and results’ (oTTer) project
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-10-29
    Claudine Bowyer-Crane; Dea Nielsen; Maria Bryant; Nimarta Dharni; Rebecca Heald; Chloe Storr; Josie Dickerson

    Problems with oral language skills in childhood have been linked with poor educational, employment, and mental health outcomes. In the UK, there is increasing concern about the oral language skills of children, particularly children from areas of social disadvantage. Research emphasises the importance of the home language environment as a fundamental bedrock for the development of oral language skills. It is vital, therefore, that support is available to help families in need to provide the optimal language environment for their child. Talking Together is a 6-week home visiting programme recently commissioned by Better Start Bradford to develop parents’ knowledge of the importance of a good language environment and help to improve parent-child interactions. This study represents the initial steps in developing a definitive trial of the Talking Together programme. This study is a two-arm randomised controlled feasibility study in which families referred into the Talking Together programme and consent to participate in the trial will be randomly allocated to either an intervention group or a waiting control group. We will assess the recruitment and retention rates, the representativeness of our sample, the appropriateness of our measures, and the sample size needed for a definitive trial. We will also carry out a qualitative evaluation to explore the acceptability of trial procedures for families and service providers, fidelity of delivery, time and resources for training, and barriers and facilitators to engagement with the programme. Clear progression criteria will be used to assess suitability for a definitive trial. This feasibility study will inform the development of a definitive trial of this home-based visiting programme, which will add to the sparse evidence base on which practitioners can draw when supporting families in need. The lessons learnt from this feasibility study will also inform the wider evaluation work of the Better Start Bradford Innovation Hub. The trial is registered with the ISRCTN registry: study ID ISRCTN13251954 . Date of registration: 21 February 2019 (the trial was retrospectively registered).

    更新日期:2019-11-28
  • The reporting of progression criteria in protocols of pilot trials designed to assess the feasibility of main trials is insufficient: a meta-epidemiological study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-03
    Lawrence Mbuagbaw; Sarah Daisy Kosa; Daeria O. Lawson; Rosa Stalteri; Oluwatobi R. Olaiya; Ahlam Alotaibi; Lehana Thabane

    Pilot and feasibility trials are conducted to determine feasibility or to collect information that would inform the design of a larger definitive trial. Clear progression criteria are required to determine if a definitive or main trial is feasible and how it should be designed. We sought to determine how often progression criteria are reported and the associated factors. We conducted a methodological review of protocols for pilot randomised trials published in three journals that publish research protocols (BMJ Open, Trials, Pilot and Feasibility Studies), using a PubMed search (2013–2017). We extracted bibliometric information including the country in which the study was conducted, source of funding, type of intervention, use of a primary feasibility outcome, sample size reporting, and justification. We used generalised linear models to determine the factors associated with reporting progression criteria. Our search retrieved 276 articles, of which 49 were not eligible. We included 227 articles. Overall, 45/227 (19.8%; 95% confidence interval [CI] 14.8–25.6) reported progression criteria. Protocols published in more recent years were significantly associated with higher odds of reporting progression criteria (adjusted odds ratio [aOR] 1.40; 95% CI 1.03–1.92; p = 0.034). Pilot trials from Europe (aOR 0.19; 95% CI 0.08–0.48; p < 0.001) and the rest of the world (aOR 0.05; 95% CI 0.01–0.18; p < 0.003) compared to North America were significantly associated with lower odds of reporting progression criteria. Journal, source of funding, sample size, intervention type, and having a primary outcome related to feasibility were not significantly associated with reporting progression criteria. Progression criteria are not often explicitly stated in protocols of pilot trials leaving room for varied interpretation of findings. The development of formal guidance for progression criteria in protocols of pilot trials is warranted.

    更新日期:2019-11-28
  • Bedside breath tests in children with abdominal pain: a prospective pilot feasibility study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-05
    David C. Wong; Samuel D. Relton; Victoria Lane; Mohamed Ismail; Victoria Goss; Jane Bytheway; Robert M. West; Jim Deuchars; Jonathan Sutcliffe

    There is no definitive method of accurately diagnosing appendicitis before surgery. We evaluated the feasibility of collecting breath samples in children with abdominal pain and gathered preliminary data on the accuracy of breath tests. We conducted a prospective pilot study at a large tertiary referral paediatric hospital in the UK. We recruited 50 participants with suspected appendicitis, aged between 5 and 15 years. Five had primary diagnosis of appendicitis. The primary outcome was the number of breath samples collected. We also measured the number of samples processed within 2 h and had CO2 ≥ 3.5%. Usability was assessed by patient-reported pain pre- and post-sampling and user-reported sampling difficulty. Logistic regression analysis was used to predict appendicitis and evaluated using the area under the receiver operator characteristic curve (AUROC). Samples were collected from all participants. Of the 45 samples, 36 were processed within 2 h. Of the 49 samples, 19 had %CO2 ≥ 3.5%. No difference in patient-reported pain was observed (p = 0.24). Sampling difficulty was associated with patient age (p = 0.004). The logistic regression model had AUROC = 0.86. Breath tests are feasible and acceptable to patients presenting with abdominal pain in clinical settings. We demonstrated adequate data collection with no evidence of harm to patients. The AUROC was better than a random classifier; more specific sensors are likely to improve diagnostic performance. ClinicalTrials.gov, NCT03248102 . Registered 14 Aug 2017.

    更新日期:2019-11-28
  • A website for pilot and feasibility studies: giving your research the best chance of success
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-05
    Claire Louise Chan

    This editorial introduces a website for pilot and feasibility studies. Pilot and feasibility studies are about giving research the best chance of success, but must be performed well to have the greatest benefit. The website was developed by the Pilot and Feasibility Studies collaboration who developed the CONSORT Extension to Pilot and Feasibility Trials as a resource to help triallists and researchers perform well conducted pilot and feasibility studies. The website is also aimed at those interested in the latest methodology for these studies. We aim to keep the site updated with the latest publications and events related to pilot and feasibility studies and welcome feedback and suggestions from the research community on further resources or events to add.

    更新日期:2019-11-28
  • A step towards equitable clinical trial recruitment: a protocol for the development and preliminary testing of an online prostate cancer health information and clinical trial matching tool
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-07
    Hala T. Borno; Brian M. Bakke; Celia Kaplan; Anke Hebig-Prophet; Jessica Chao; Yoon-Ji Kim; Jan Yeager; Pelin Cinar; Eric Small; Christy Boscardin; Ralph Gonzales

    Recruitment of a diverse participant pool to cancer clinical trials is an essential component of clinical research as it improves the generalizability of findings. Investigating and piloting novel recruitment strategies that take advantage of ubiquitous digital technologies has become an important component of facilitating broad recruitment and addressing inequities in clinical trial participation. Equitable and inclusive recruitment improves generalizability of clinical trial outcomes, benefiting patients, clinicians, and the research community. The increasing prevalence of online connectivity in the USA and use of the Internet as a resource for medical information provides an opportunity for digital recruitment strategies in cancer clinical trials. This study aims to measure the acceptability, preliminary estimates of efficacy, and feasibility of the Trial Library intervention, an Internet-based cancer clinical trial matching tool. This study will also examine the extent to which the Trial Library website, designed to address the linguistic and literacy needs of broader patient populations, influences patient-initiated conversations with physicians about clinical trial participation. This is a study protocol for a non-randomized, single-arm pilot study. This is a mixed methods study design that utilizes the statistical analysis of quantitative survey data and the qualitative analysis of interview data to assess the participant experience with the Trial Library intervention. This study will examine (1) acceptability as a measure of participant satisfaction with this intervention, (2) preliminary measure of efficacy as a measure of proportion of participants with documented clinical trial discussion in the electronic medical record, and (3) feasibility of the intervention as a measure of duration of clinical visit. The principles that informed the design of the Trial Library intervention aim to be generalizable to clinical trials across many disease contexts. From the ground up, this intervention is built to be inclusive of the linguistic, literacy, and technological needs of underrepresented patient populations. This study will collect essential preliminary data prior to a multi-site randomized clinical trial of the Trial Library intervention. This study has received institutional approval from the Committee of Human Subjects Research at the University of California, San Francisco.

    更新日期:2019-11-28
  • A study protocol for testing the feasibility of a randomised stepped wedge cluster design to investigate a Community Health Intervention through Musical Engagement (CHIME) for perinatal mental health in The Gambia
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-07
    Katie Rose M. Sanfilippo; Bonnie McConnell; Victoria Cornelius; Buba Darboe; Hajara B. Huma; Malick Gaye; Paul Ramchandani; Hassoum Ceesay; Vivette Glover; Ian Cross; Lauren Stewart

    Perinatal mental health problems affect up to one in five women worldwide. Mental health problems in the perinatal period are a particular challenge in low- and middle-income countries (LMICs) where they can be at least twice as frequent as in higher-income countries. It is thus of high priority to develop new low-cost, low-resource, non-stigmatising and culturally appropriate approaches to reduce symptoms of anxiety and depression perinatally, for the benefit of both mother and child. Music-centred approaches may be particularly useful in The Gambia since a range of musical practices that specifically engage pregnant women and new mothers already exist. This protocol is for a study to examine the feasibility of undertaking a stepped wedge trial to test how a Community Health Intervention through Musical Engagement (CHIME) could be beneficial in alleviating perinatal mental distress in The Gambia. In this study, we plan to recruit 120 pregnant women (n = 60 intervention, n = 60 control) at four antenatal clinics over two 6-week stepped sequences. Women in the intervention will participate in weekly group-singing sessions, led by local Kanyeleng singing groups, for 6 weeks. The control group will receive standard care. We will assess symptoms of anxiety and depression using the Edinburgh Postnatal Depression Scale (EPDS) and the Self-Reporting Questionnaire (SRQ-20). The feasibility of the design will be assessed through recruitment, retention and attrition rates of participants, clinics' adherence to the schedule and completeness of data by site. Qualitative interviews and video and audio recordings will be used to evaluate the acceptability of the intervention. This feasibility trial will allow us to determine whether a larger trial with the same intervention and target group is feasible and acceptable in The Gambia. Retrospectively registered (24/01/2019) with Pan African Clinical Trials Registry (PACTR): PACTR201901917619299.

    更新日期:2019-11-28
  • The feasibility and impact of embedding pedagogical strategies targeting physical activity within undergraduate teacher education: Transform-Ed!
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-07
    Natalie Lander; Harriet Koorts; Emiliano Mazzoli; Kate Moncrieff; Jo Salmon

    Low levels of physical activity and high levels of sedentary behaviour are pervasive, especially in schools. Pre-service teacher education is pivotal to school and educational reform but is an under-studied setting for physical activity and sedentary behaviour intervention research. The objective of this pilot study was to test the feasibility and potential impact of embedding evidence-based active pedagogy based on an adapted version of Transform-Us!, Transform-Ed! in one core unit of an undergraduate teacher education degree. Baseline and follow-up measures (i.e. surveys) were conducted with Bachelor of Education (Primary) pre-service teachers who received the Transform-Ed! intervention and academic educators who delivered the intervention. Focus groups of senior academics and telephone interviews with primary school principals examined perceptions of intervention feasibility and explored potential real-world relevance and impact of pre-service teachers training in active pedagogy. After 12 weeks, pre-service teachers (n = 218) were significantly more willing (pre–post change Δ = 0.54, 95% CI [0.16, 0.91]), confident (Δ = 1.40, 95% CI [0.89, 1.91]) and competent (Δ = 2.39, 95% CI [1.85, 2.92]) to deliver Transform-Ed!, had more positive feelings about the impact of physical activity on student outcomes (Δ = 2.05, 95% CI [1.58, 2.52]), and perceived fewer barriers to integrating Transform-Ed! into current and future teaching (Δ = − 7.26, 95% CI [− 8.88, − 5.64]). Four major themes emerged from the focus groups (n = 9) and interviews (n = 5) around participant perceptions of Transform-Ed!: (i) acceptability and appropriateness, (ii) need (tertiary level), (iii) need (primary level) and (iv) overcoming challenges. The Transform-Ed! pilot study demonstrated promising results across multiple participant levels, as it was perceived to be feasible, acceptable and appropriate by pre-service teachers, academics and school principals. The findings have direct implications for the progression of Transform-Ed! from pilot to a future definitive trial.

    更新日期:2019-11-28
  • Implementation of mifepristone medical abortion in Canada: pilot and feasibility testing of a survey to assess facilitators and barriers
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-08
    Courtney Devane; Regina M. Renner; Sarah Munro; Édith Guilbert; Sheila Dunn; Marie-Soleil Wagner; Wendy V. Norman

    Direct primary care provision of first-trimester medical abortion could potentially address inequitable abortion access in Canada. However, when Health Canada approved the combination medication Mifegymiso® (mifepristone 200 mg/misoprostol 800 mcg) for medical abortion in July 2015, we hypothesized that the restrictions to distribution, prescribing, and dispensing would impede the uptake of this evidence-based innovation in primary care. We developed and pilot-tested a survey related to policy and practice facilitators and barriers to assess successful initiation and ongoing clinical provision of medical abortion service by physicians undertaking mifepristone training. Additionally, we explored expert, stakeholder, and physician perceptions of the impact of facilitators and barriers on abortion services throughout Canada. In phase 1, we developed a survey using 2 theoretical frameworks: Greenhalgh’s conceptual model for the Diffusion of Innovations in health service organizations (which we operationalized) and Godin’s framework to assess the impact of professional development on the uptake of new practices operationalized in Légaré’s validated questionnaire. We finalized questions in phase 2 using the modified Delphi methodology. The survey was then tested by an expert panel of 25 nationally representative physician participants and 4 clinical content experts. Qualitative analysis of transcripts enriched and validated the content by identifying these potential barriers: physicians dispensing the medication, mandatory training to become a prescriber, burdens for patients, lack of remuneration for mifepristone provision, and services available in my community. To assess the usability and reliability of the online survey, in phase 3, we pilot-tested the survey for feasibility. We developed and tested a 61-item Mifepristone Implementation Survey suitable to study the facilitators and barriers to implementation of mifepristone first-trimester medical abortion practice by physicians in Canada. Our team operationalized Greenhalgh’s theoretical framework for Diffusion of Innovations in health systems to explore factors influencing the implementation of first-trimester medical abortion provision. This process may be useful for those evaluating other health system innovations. Identification of facilitators and barriers to implementation of mifepristone practice in Canada and knowledge translation has the potential to inform regulatory and health system changes to support and scale up facilitators and mitigate barriers to equitable medical abortion provision.

    更新日期:2019-11-28
  • Developing interventions to improve health: a systematic mapping review of international practice between 2015 and 2016
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-08
    Liz Croot; Alicia O’Cathain; Katie Sworn; Lucy Yardley; Katrina Turner; Edward Duncan; Pat Hoddinott

    Researchers publish the processes they use to develop interventions to improve health. Reflecting on this endeavour may help future developers to improve their practice. Our aim was to collate, describe, and analyse the actions developers take when developing complex interventions to improve health. We carried out a systematic mapping review of empirical research studies that report the development of complex interventions to improve health. A search was undertaken of five databases over 2015–2016 using the term ‘intervention dev*’. Eighty-seven journal articles reporting the process of intervention development were identified. A purposive subset of 30 articles, using a range of published approaches to developing interventions, was selected for in-depth analysis using principles of realist synthesis to identify the actions of intervention development and rationales underpinning those actions. The 87 articles were from the USA (39/87), the UK (32/87), continental Europe (6/87), and the rest of the world (10/87). These mainly took a pragmatic self-selected approach (n = 43); a theory- and evidence-based approach, e.g. Intervention Mapping, Behaviour Change Wheel (n = 22); or a partnership approach, e.g. community-based participatory research, co-design (n = 10). Ten actions of intervention development were identified from the subset of 30 articles, including identifying a need for an intervention, selecting the intervention development approach to follow, considering the needs of the target population, reviewing published evidence, involving stakeholders, drawing or generating theory, and designing and refining the intervention. Rationales for these actions were that they would produce more engaging, acceptable, feasible, and effective interventions. Developers take a variety of approaches to the international endeavour of complex intervention development. We have identified and described a set of actions taken within this endeavour regardless of whether developers follow a published approach or not. Future developers can use these actions and the rationales that underpin them to help them make decisions about the process of intervention development. PROSPERO, CRD42017080545.

    更新日期:2019-11-28
  • BRInging the Diabetes prevention program to GEriatric populations (BRIDGE): a feasibility study
    Pilot Feasibility Stud. (IF 0) Pub Date : 2019-11-11
    Jeannette M. Beasley; Lindsey Kirshner; Judith Wylie-Rosett; Mary Ann Sevick; Laura DeLuca; Joshua Chodosh

    The purpose of this 6-week intervention was to test the feasibility and acceptability of implementing a telehealth-adapted Diabetes Prevention Program (DPP) at a senior center. Older adults (n = 16) attended weekly interactive webinars. At each measurement time point, participants completed questionnaires covering lifestyle, physical activity, quality of life, and food records and wore physical activity trackers. Qualitative data were gathered from 2 focus groups inviting all 16 participants with 13 and 10 participants attending, respectively. Over 2000 senior center members were contacted, approximately 2% (n = 39) responded to the recruitment email, and 16 were recruited into the study. Retention was 75%, and attendance rates averaged 80% across the six intervention sessions. The focus group participants provided positive opinions for most program components, especially the webinar group interaction and using physical activity trackers. Suggestions for improvement included a greater focus on specific needs of older adults (i.e., adapting activities) and placing a greater emphasis on dietary strategies to prevent diabetes. Mean weight loss was 2.9% (2.7 kg [95% CI 1.6, 3.7]; p value = 0.001). The feasibility of providing DPP via webinar appears to be high based on the retention and attendance rates. Similar to other behavioral interventions engaging older adults, recruitment rates were low. Acceptability was evidenced by high attendance at the intervention sessions and feedback from participants during focus group sessions. The intervention efficacy should be evaluated based on CDC criteria for program recognition in a larger scale randomized trial. NCT03524404. Registered 14 May 2018—retrospectively registered. Trial protocol will be provided by the corresponding author upon request.

    更新日期:2019-11-28
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