Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/29659
Title: Protocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS).
Austin Authors: Cadilhac, Dominique A;Cameron, Jan;Kilkenny, Monique F;Andrew, Nadine E;Harris, Dawn;Ellery, Fiona;Thrift, Amanda G;Purvis, Tara;Kneebone, Ian;Dewey, Helen;Drummond, Avril;Hackett, Maree;Grimley, Rohan;Middleton, Sandy;Thijs, Vincent N ;Cloud, Geoffrey;Carey, Mariko;Butler, Ernest;Ma, Henry;Churilov, Leonid ;Hankey, Graeme J;English, Coralie;Lannin, Natasha A
Affiliation: Department of Neurology, Alfred Health, Melbourne, Australia
Neurology
Nursing Research Institute, Australian Catholic University, Sydney, Australia..
Nursing Research Institute, St Vincent's Health Network, Sydney, Australia..
Sunshine Coast Clinical School, Griffith University, Birtinya, Australia..
The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia..
Department of Neurosciences, Eastern Health, Box Hill, Australia..
Eastern Health Clinical School, Monash University, Clayton, Australia..
Department of Medicine, School of Clinical Sciences at Monash Health, Monash University, Clayton, Australia..
The Florey Institute of Neuroscience and Mental Health
Peninsula Clinical School, Central Clinical School, Monash University, Clayton, Australia..
Graduate School of Health, University of Technology Sydney, Ultimo, Australia..
Professorial Academic Unit, Frankston Hospital, Peninsula Health, Frankston, Australia..
School of Health Science and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, Callaghan, Australia..
Medical School, Faculty of Health and Medical Sciences, The University of Western Australia, Perth, Australia..
Melbourne Medical School, University of Melbourne, Parkville, Australia..
School of Medicine and Public Health, University of Newcastle, Callaghan, Australia..
Department of Neuroscience, Central Clinical School, Monash University, Melbourne, Australia..
Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham, UK..
Issue Date: Feb-2022
Date: 2021
Publication information: International journal of stroke : official journal of the International Stroke Society 2022; 17(2): 236-241
Abstract: To address unmet needs, electronic messages to support person-centered goal attainment and secondary prevention may avoid hospital presentations/readmissions after stroke, but evidence is limited. Compared to control participants, there will be a 10% lower proportion of intervention participants who represent to hospital (emergency/admission) within 90 days of randomization. Multicenter, double-blind, randomized controlled trial with intention-to-treat analysis. The intervention group receives 12 weeks of personalized, goal-centered, and administrative electronic messages, while the control group only receive 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 ≥18 years with internet/mobile phone access, discharged directly home from hospital. Randomization: 1:1 computer-generated, stratified by age and baseline disability. Outcomes assessments: Collected at 90 days and 12 months following randomization. Primary outcomes include hospital emergency presentations/admissions within 90 days of randomization. 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 α = 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. We will provide new evidence on the potential effectiveness, implementation, and cost-effectiveness of a tailored eHealth intervention for survivors of stroke.
URI: https://ahro.austin.org.au/austinjspui/handle/1/29659
DOI: 10.1177/17474930211022678
ORCID: https://orcid.org/0000-0001-8162-682X
https://orcid.org/0000-0002-3375-287X
https://orcid.org/0000-0002-4846-2840
https://orcid.org/0000-0002-1410-4332
https://orcid.org/0000-0001-8533-4170
https://orcid.org/0000-0003-1211-9087
https://orcid.org/0000-0002-7006-6908
https://orcid.org/0000-0002-7201-4394
https://orcid.org/0000-0002-6044-7328
https://orcid.org/0000-0001-5910-7927
https://orcid.org/0000-0002-2066-8345
0000-0002-7302-1895
0000-0002-6614-8417
0000-0002-9807-6606
Journal: International journal of stroke : official journal of the International Stroke Society
PubMed URL: 34037468
PubMed URL: https://pubmed.ncbi.nlm.nih.gov/34037468/
Type: Journal Article
Subjects: Stroke
clinical trial protocol
eHealth
healthcare technology
self-management
Appears in Collections:Journal articles

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