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

• Published in: International Journal of Stroke 2022-02, Vol.17 (2), p.236-241
• Main 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, Cloud, Geoffrey, Carey, Mariko, Butler, Ernest, Ma, Henry, Churilov, Leonid, Hankey, Graeme J, English, Coralie, Lannin, Natasha A
• Format: Article
• Language: English
• ISSN: 1747-4930; 1747-4949
• DOI: 10.1177/17474930211022678

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