TY - JOUR
T1 - Protocol of a randomized controlled trial investigating the effectiveness of Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS)
AU - Cadilhac, Dominique A.
AU - Cameron, Jan
AU - Kilkenny, Monique F.
AU - Andrew, Nadine E.
AU - Harris, Dawn
AU - Ellery, Fiona
AU - Thrift, Amanda G.
AU - Purvis, Tara
AU - Kneebone, Ian
AU - Dewey, Helen
AU - Drummond, Avril
AU - Hackett, Maree
AU - Grimley, Rohan
AU - Middleton, Sandy
AU - Thijs, Vincent
AU - Cloud, Geoffrey
AU - Carey, Mariko
AU - Butler, Ernest
AU - Ma, Henry
AU - Churilov, Leonid
AU - Hankey, Graeme J.
AU - English, Coralie
AU - Lannin, Natasha A.
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Funding for the trial has been received from the Victorian government (Victorian Medical Research Acceleration Fund), Monash University and the National Health and Medical Research Council (NHMRC: project 1162596). The following authors also received research fellowship support from the NHMRC (DAC: 1154273, MLH 1141328) and the Heart Foundation, Australia (NAL: 102055).
Publisher Copyright:
© 2021 World Stroke Organization.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2022/2
Y1 - 2022/2
N2 - 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.
AB - 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.
KW - clinical trial protocol
KW - eHealth
KW - healthcare technology
KW - self-management
KW - Stroke
UR - http://www.scopus.com/inward/record.url?scp=85108011017&partnerID=8YFLogxK
U2 - 10.1177/17474930211022678
DO - 10.1177/17474930211022678
M3 - Article
C2 - 34037468
AN - SCOPUS:85108011017
SN - 1747-4930
VL - 17
SP - 236
EP - 241
JO - International Journal of Stroke
JF - International Journal of Stroke
IS - 2
ER -