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

Dominique Cadilhac, Jan Cameron, Monique F Kilkenny, Nadine Elizabeth Andrew, Dawn Harris, Fiona Ellery, Amanda G Thrift, Tara Purvis, Ian Kneebone, Helen Dewey, Avril Drummond, Maree L Hackett, Rohan Grimley, Sandy Middleton, Vincent Thijs, Geoffrey Cloud, Mariko L Carey, Ernest Butler, Henry Ma, Leonid ChurilovGraeme J Hankey, Coralie Kym English, Natasha A Lannin

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Abstract

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 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.

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

Original languageEnglish
JournalInternational Journal of Stroke
DOIs
Publication statusE-pub ahead of print - 26 May 2021

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