Digitally enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial.,PLOS Medicine

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Digitally enabled aged care and neurological rehabilitation to enhance outcomes with Activity and MObility UsiNg Technology (AMOUNT) in Australia: A randomised controlled trial.
PLOS Medicine ( IF 10.5 ) Pub Date : 2020-02-18 , DOI: 10.1371/journal.pmed.1003029
Leanne Hassett _{1,

2} , Maayken van den Berg _{3,

4} , Richard I Lindley ₅ , Maria Crotty ₃ , Annie McCluskey _{2,

6} , Hidde P van der Ploeg _{7,

8} , Stuart T Smith ₉ , Karl Schurr ₆ , Kirsten Howard ₈ , Maree L Hackett _{10,

11} , Maggie Killington ₃ , Bert Bongers ₁₂ , Leanne Togher ₂ , Daniel Treacy _{1,

13} , Simone Dorsch _{6,

14,

15} , Siobhan Wong _{1,

16} , Katharine Scrivener _{6,

17} , Sakina Chagpar ₁ , Heather Weber ₃ , Marina Pinheiro _{1,

2} , Stephane Heritier ₁₈ , Catherine Sherrington ₁

Affiliation

Institute for Musculoskeletal Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
School of Health Sciences, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
Rehabilitation, Aged and Extended Care, College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
Clinical Rehabilitation, College of Nursing and Health Sciences, Flinders University, Adelaide, South Australia, Australia.
Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
StrokeEd Collaboration, Sydney, New South Wales, Australia.
Department of Public & Occupational Health, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.
School of Public Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.
School of Health and Human Sciences, Southern Cross University, Coffs Harbour, New South Wales, Australia.
The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Faculty of Health and Wellbeing, University of Central Lancashire, Preston, United Kingdom.
Faculty of Design, Architecture and Building, University of Technology Sydney, Sydney, New South Wales, Australia.
Physiotherapy Department, Prince of Wales Hospital, South Eastern Sydney Local Health District, Sydney, New South Wales, Australia.
Physiotherapy Department and Department of Aged Care and Rehabilitation, Bankstown-Lidcombe Hospital, South Western Sydney Local Health District, Sydney, New South Wales, Australia.
School of Physiotherapy, Faculty of Health Sciences, Australian Catholic University, Sydney, New South Wales, Australia.
Physiotherapy Department and Brain Injury Rehabilitation Unit, Liverpool Hospital, South Western Sydney Local Health District, Sydney, New South Wales, Australia.
Faculty of Medicine and Health Sciences, Macquarie University, Sydney, New South Wales, Australia.
Department of Epidemiology and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.

BACKGROUND Digitally enabled rehabilitation may lead to better outcomes but has not been tested in large pragmatic trials. We aimed to evaluate a tailored prescription of affordable digital devices in addition to usual care for people with mobility limitations admitted to aged care and neurological rehabilitation. METHODS AND FINDINGS We conducted a pragmatic, outcome-assessor-blinded, parallel-group randomised trial in 3 Australian hospitals in Sydney and Adelaide recruiting adults 18 to 101 years old with mobility limitations undertaking aged care and neurological inpatient rehabilitation. Both the intervention and control groups received usual multidisciplinary inpatient and post-hospital rehabilitation care as determined by the treating rehabilitation clinicians. In addition to usual care, the intervention group used devices to target mobility and physical activity problems, individually prescribed by a physiotherapist according to an intervention protocol, including virtual reality video games, activity monitors, and handheld computer devices for 6 months in hospital and at home. Co-primary outcomes were mobility (performance-based Short Physical Performance Battery [SPPB]; continuous version; range 0 to 3; higher score indicates better mobility) and upright time as a proxy measure of physical activity (proportion of the day upright measured with activPAL) at 6 months. The dataset was analysed using intention-to-treat principles. The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12614000936628). Between 22 September 2014 and 10 November 2016, 300 patients (mean age 74 years, SD 14; 50% female; 54% neurological condition causing activity limitation) were randomly assigned to intervention (n = 149) or control (n = 151) using a secure online database (REDCap) to achieve allocation concealment. Six-month assessments were completed by 258 participants (129 intervention, 129 control). Intervention participants received on average 12 (SD 11) supervised inpatient sessions using 4 (SD 1) different devices and 15 (SD 5) physiotherapy contacts supporting device use after hospital discharge. Changes in mobility scores were higher in the intervention group compared to the control group from baseline (SPPB [continuous, 0-3] mean [SD]: intervention group, 1.5 [0.7]; control group, 1.5 [0.8]) to 6 months (SPPB [continuous, 0-3] mean [SD]: intervention group, 2.3 [0.6]; control group, 2.1 [0.8]; mean between-group difference 0.2 points, 95% CI 0.1 to 0.3; p = 0.006). However, there was no evidence of a difference between groups for upright time at 6 months (mean [SD] proportion of the day spent upright at 6 months: intervention group, 18.2 [9.8]; control group, 18.4 [10.2]; mean between-group difference -0.2, 95% CI -2.7 to 2.3; p = 0.87). Scores were higher in the intervention group compared to the control group across most secondary mobility outcomes, but there was no evidence of a difference between groups for most other secondary outcomes including self-reported balance confidence and quality of life. No adverse events were reported in the intervention group. Thirteen participants died while in the trial (intervention group: 9; control group: 4) due to unrelated causes, and there was no evidence of a difference between groups in fall rates (unadjusted incidence rate ratio 1.19, 95% CI 0.78 to 1.83; p = 0.43). Study limitations include 15%-19% loss to follow-up at 6 months on the co-primary outcomes, as anticipated; the number of secondary outcome measures in our trial, which may increase the risk of a type I error; and potential low statistical power to demonstrate significant between-group differences on important secondary patient-reported outcomes. CONCLUSIONS In this study, we observed improved mobility in people with a wide range of health conditions making use of digitally enabled rehabilitation, whereas time spent upright was not impacted. TRIAL REGISTRATION The trial was prospectively registered with the Australian New Zealand Clinical Trials Register; ACTRN12614000936628.

中文翻译：

数字化的老年护理和神经系统康复可以通过澳大利亚的活动和移动性联合技术（AMOUNT）增强结果：一项随机对照试验。

背景技术数字化康复可能导致更好的结果，但是尚未在大型实用试验中进行测试。我们的目标是评估针对因行动不便而需要老年护理和神经康复治疗的人们的常规护理，以及可负担得起的数字设备的定制处方。方法和研究结果我们在悉尼和阿德莱德的3家澳大利亚医院进行了一项实用，结果评估盲，平行分组的随机试验，招募了18至101岁行动不便的成年人，并接受了老年护理和神经科住院康复。干预组和对照组均接受由治疗康复临床医生确定的常规多学科住院和院后康复护理。除了日常护理外，干预小组使用了针对物理运动和身体活动问题的设备，这些设备是物理治疗师根据干预协议单独规定的，包括虚拟现实视频游戏，活动监视器和手持计算机设备，可在医院和家中使用6个月。共同主要的结果是移动性（基于性能的短期体能电池[SPPB]；连续版本；范围为0到3；得分越高表示移动性越好）和直立时间作为身体活动的替代指标（一天直立的比例用activPAL）在6个月。使用意向治疗原则对数据集进行了分析。该试验已在澳大利亚新西兰临床试验注册中心（ACTRN12614000936628）进行了前瞻性注册。在2014年9月22日至2016年11月10日之间，共有300名患者（平均年龄74岁，SD 14; 50％女性；使用安全的在线数据库（REDCap）将54％导致活动受限的神经系统疾病随机分配给干预（n = 149）或对照（n = 151），以实现分配隐藏。258名参与者完成了六个月的评估（129名干预者，129名对照者）。干预参与者在出院后平均使用4种（SD 1）不同设备和15种（SD 5）理疗联系人支持了使用该设备的平均12次（SD 11）监督住院时间。从基线开始（SPPB [连续，0-3]平均值[SD]：干预组1.5 [0.7]；对照组1.5 [0.8]）至6个月，干预组的活动性评分变化高于对照组。（SPPB [连续，0-3]平均值[SD]：干预组，2.3 [0.6]；对照组，2.1 [0.8]；组间平均差异0。2分，95％CI 0.1至0.3; p = 0.006）。但是，没有证据表明两组在6个月的直立时间上有差异（6个月时直立的一天的平均[SD]比例：干预组为18.2 [9.8]；对照组为18.4 [10.2]；组差异-0.2，95％CI -2.7至2.3； p = 0.87）。在大多数次要活动性结局中，干预组的得分均高于对照组，但没有证据表明大多数其他次要结局之间存在差异，包括自我报告的平衡信心和生活质量。干预组未报告不良事件。在试验中，有13位参与者由于不相关的原因死亡（干预组：9；对照组：4），而且没有证据表明两组之间的跌倒率有差异（未调整的发病率比1.19，95％CI为0.78至1.83； p = 0.43）。研究的局限性包括，如预期的那样，在6个月的随访中失去15％-19％的随访结果；我们的试验中次要结局指标的数量，这可能会增加I型错误的风险；以及潜在的较低的统计能力，以证明重要的继发患者报告的结局之间存在明显的组间差异。结论在这项研究中，我们观察到通过使用数字化康复技术，在具有多种健康状况的人群中活动能力得到了改善，而直立花费的时间没有受到影响。试验注册该试验已在澳大利亚新西兰临床试验注册中心进行了注册；ACTRN12614000936628。83; p = 0.43）。研究的局限性包括，如预期的那样，在6个月的随访中失去15％-19％的随访结果；我们的试验中次要结局指标的数量，这可能会增加I型错误的风险；以及潜在的较低的统计能力，以证明重要的继发患者报告的结局之间存在明显的组间差异。结论在这项研究中，我们观察到通过使用数字化康复技术，在具有多种健康状况的人群中活动能力得到了改善，而直立花费的时间没有受到影响。试验注册该试验已在澳大利亚新西兰临床试验注册中心进行了注册；ACTRN12614000936628。83; p = 0.43）。研究的局限性包括，如预期的那样，在6个月的随访中失去15％-19％的随访结果；我们的试验中次要结局指标的数量，这可能会增加I型错误的风险；以及潜在的较低的统计能力，以证明重要的继发患者报告的结局之间存在显着的组间差异。结论在这项研究中，我们观察到利用数字化康复技术可以改善各种健康状况的人们的活动能力，而直立的时间不会受到影响。试验注册该试验已在澳大利亚新西兰临床试验注册中心进行了注册；ACTRN12614000936628。我们的试验中次要结局指标的数量，这可能会增加I型错误的风险；以及潜在的低统计能力，以证明在重要的继发患者报告的结局方面存在显着的组间差异。结论在这项研究中，我们观察到利用数字化康复技术可以改善各种健康状况的人们的活动能力，而直立的时间不会受到影响。试验注册该试验已在澳大利亚新西兰临床试验注册中心进行了注册；ACTRN12614000936628。我们的试验中次要结局指标的数量，这可能会增加I型错误的风险；以及潜在的较低的统计能力，以证明重要的继发患者报告的结局之间存在显着的组间差异。结论在这项研究中，我们观察到利用数字化康复技术可以改善各种健康状况的人们的活动能力，而直立的时间不会受到影响。试验注册该试验已在澳大利亚新西兰临床试验注册中心进行了注册；ACTRN12614000936628。我们观察到，利用数字化康复技术，各种健康状况的人们的活动能力得到了改善，而直立花费的时间没有受到影响。试验注册该试验已在澳大利亚新西兰临床试验注册中心进行了注册；ACTRN12614000936628。我们观察到，通过数字支持的康复，各种健康状况的人们的活动能力得到了改善，而直立花费的时间没有受到影响。试验注册该试验已在澳大利亚新西兰临床试验注册中心进行了注册；ACTRN12614000936628。

更新日期：2020-02-19

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