EXPRESS: Protocol of a randomised controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS).
Cadilhac, D
Cameron, J
Kilkenny, MF
Andrew, NE
Harris, D
Ellery, F
Thrift, AG
Purvis, T
Kneebone, I
Dewey, H
Drummond, A
Hackett, ML
Grimley, R
Middleton, S
Thijs, V
Cloud, G
Carey, ML
Butler, E
Ma, H
Churilov, L
Hankey, GJ
English, CK
Lannin, NA
Dewey, H
Drummond, A
Hackett, ML
Grimley, R
Middleton, S
Thijs, V
Cloud, G
Carey, ML
Butler, E
Ma, H
Churilov, L
Hankey, GJ
English, CK
Lannin, NA
- Publisher:
- SAGE Publications
- Publication Type:
- Journal Article
- Citation:
- International Journal of Stroke, 2021, pp. 17474930211022678
- Issue Date:
- 2021-05-26
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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.Please use this identifier to cite or link to this item: