Protocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS).
Int J Stroke
; 17(2): 236-241, 2022 Feb.
Article
in English
| MEDLINE | ID: covidwho-1272081
ABSTRACT
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 ANDDESIGN:
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 11 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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Stroke
/
COVID-19
Type of study:
Experimental Studies
/
Prognostic study
/
Randomized controlled trials
Limits:
Adolescent
/
Adult
/
Humans
Language:
English
Journal:
Int J Stroke
Year:
2022
Document Type:
Article
Affiliation country:
17474930211022678
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