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Title: EXPRESS: Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS).
Austin Authors: Cadilhac, Dominique;Cameron, Jan;Kilkenny, Monique F;Andrew, Nadine Elizabeth;Harris, Dawn;Ellery, Fiona;Thrift, Amanda G;Purvis, Tara;Kneebone, Ian;Dewey, Helen;Drummond, Avril;Hackett, Maree L;Grimley, Rohan;Middleton, Sandy;Thijs, Vincent N ;Cloud, Geoffrey;Carey, Mariko L;Butler, Ernest;Ma, Henry;Churilov, Leonid ;Hankey, Graeme J;English, Coralie Kym;Lannin, Natasha A
Affiliation: The University of Newcastle, School of Health Science and Priority Research Centre for Stroke and Brain Injury, Callaghan, New South Wales, Australia
Alfred Health, Department of Neurology, Melbourne, Victoria, Australia
Monash University, Department of Clinical Neuroscience, Central Clinical School, Clayton, Victoria, Australia
University of Newcastle, School of Medicine and Public Health, Callaghan, New South Wales, Australia
Peninsula Health, Frankston, Victoria, Australia
The Florey Institute of Neuroscience and Mental Health
Monash University, Peninsula Clinical School, Central Clinical School, Clayton, Victoria, Australia
Monash University, Epidemiology and Prevention Unit, Department of Medicine, School of Clinical Sciences, Clayton, Victoria, Australia
University of Technology Sydney, Graduate School of Health, Ultimo, New South Wales, Australia
Monash University, Eastern Health Clinical School, Clayton, Victoria, Australia
Eastern Health, Department of Neurosciences, Box Hill, Victoria, Australia
The George Institute for Global Health, Faculty of Medicine, The University of New South Wales, Sydney, New South Wales, Australia
University of Melbourne, Melbourne Medical School, Parkville, Victoria, Australia
The University of Western Australia, Faculty of Health and Medical Sciences, Perth, Australia
Monash University, Department of Medicine, School of Clinical Sciences, Clayton, Victoria, Australia
Griffith University, Sunshine Coast Clinical School, Birtinya, Queensland, Australia
St Vincent's Health Australia (Sydney), St Vincent's Hospital Melbourne, and Australian Catholic University, Nursing Research Institute, Executive Suite, Level 5 DeLacy Building, St Vincentâs Hospital , Victoria Road, Darlinghurst, New South Wales, Australia
University of Nottingham, Faculty of Medicine and Health Sciences, Nottingham, Nottingham, United Kingdom of Great Britain and Northern Ireland..
Issue Date: 26-May-2021
Date: 2021-05-26
Publication information: International Journal of Stroke 2021; online first: 26 May
Abstract: 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. 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. 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. 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. 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. 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.
DOI: 10.1177/17474930211022678
ORCID: 0000-0001-8162-682X
Journal: International Journal of Stroke
PubMed URL: 34037468
Type: Journal Article
Subjects: Clinical trial
healthcare technology
Appears in Collections:Journal articles

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