EXPRESS: Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS).,International Journal of Stroke

当前位置： X-MOL 学术 › Int. J. Stroke › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

EXPRESS: Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS).
International Journal of Stroke ( IF 6.7 ) Pub Date : 2021-05-26 , DOI: 10.1177/17474930211022678
Dominique A Cadilhac _{1,

2} , Jan Cameron ₁ , Monique F Kilkenny _{1,

2} , Nadine E Andrew _{3,

4} , Dawn Harris ₁ , Fiona Ellery ₂ , Amanda G Thrift ₁ , Tara Purvis ₁ , Ian Kneebone ₅ , Helen Dewey _{6,

7} , Avril Drummond ₈ , Maree Hackett ₉ , Rohan Grimley _{1,

10} , Sandy Middleton _{11,

12} , Vincent Thijs _{2,

13} , Geoffrey Cloud _{14,

15} , Mariko Carey ₁₆ , Ernest Butler ₄ , Henry Ma ₁ , Leonid Churilov ₁₇ , Graeme J Hankey ₁₈ , Coralie English ₁₉ , Natasha A Lannin _{14,

15}

Affiliation

Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia.
Stroke theme, Florey Institute of Neuroscience and Mental Health, Heidelberg, Australia.
Peninsula Clinical School, Central Clinical School, Monash University, Clayton, Australia.
Professorial Academic Unit, Frankston Hospital, Peninsula Health, Frankston, Australia.
Graduate School of Health, University of Technology Sydney, Ultimo, Australia.
Eastern Health Clinical School, Monash University, Clayton, Australia.
Department of Neurosciences, Eastern Health, Box Hill, Australia.
Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK.
The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia.
Sunshine Coast Clinical School, Griffith University, Birtinya, Australia.
Nursing Research Institute, St Vincent's Health Network, Sydney, Australia.
Nursing Research Institute, Australian Catholic University, Sydney, Australia.
Department of Neurology, Austin Health, Heidelberg, Australia.
Department of Neurology, Alfred Health, Melbourne, Australia.
Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Australia.
School of Medicine and Public Health, University of Newcastle, Callaghan, Australia.
Melbourne Medical School, University of Melbourne, Parkville, Australia.
Medical School, Faculty of Health and Medical Sciences, The University of Western Australia, Perth, Australia.
School of Health Science and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Callaghan, Australia.

Rationale: To address unmet needs, electronic messages to support person-centred goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited.

Hypothesis: Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomisation.

Methods and design: Multicentre, double-blind, randomised controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalised, goal-centred and administrative electronic messages, while the control group only receives administrative messages. The trial includes a process evaluation, assessment of treatment fidelity and an economic evaluation.

Participants: Confirmed stroke (modified Rankin Score: 0-4), aged â¥18 years with internet/mobile phone access, discharged directly home from hospital.

Randomisation: 1:1 computer-generated, stratified by age and baseline disability.

Outcomes Assessments: Collected at 90 days and 12 months following randomisation.

Outcomes: Primary: Hospital emergency presentations/admissions within 90 days of randomisation. Secondary outcomes include goal attainment, self-efficacy, mood, unmet needs, disability, quality-of-life, recurrent stroke/cardiovascular events/deaths at 90 days and 12 months, and death and cost-effectiveness at 12 months.

Sample size: To test our primary hypothesis, we estimated a sample size of 890 participants (445 per group) with 80% power and two-tailed significance threshold of Î±=0.05. Given uncertainty for the effect size of this novel intervention, the sample size will be adaptively re-estimated when outcomes for n=668 are obtained, with maximum sample capped at 1100.

Discussion: We will provide new evidence on the potential effectiveness, implementation and cost-effectiveness of a tailored eHealth intervention for survivors of stroke.

中文翻译：