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

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 ≥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.

A mixed-methods feasibility study of a new digital health support package for people after stroke: the Recovery-focused Community support to Avoid readmissions and improve Participation after Stroke (ReCAPS) intervention

“…The high fidelity of the delivery of the protocol led the Investigator group to confidently progress to the phase III trial with refinements introduced using the evidence from this study. Consequently, amendments to the protocol for the transition to a phase III trial were submitted and approved [ 35 ]. The phase III trial is a prospective, parallel two-group, double-blind (hospital staff, patients and outcome assessors), multi-site, individual-randomised controlled trial with intention-to-treat analysis.…”

Mixed methods evaluation to explore participant experiences of a pilot randomized trial to facilitate self‐management of people living with stroke: Inspiring virtual enabled resources following vascular events (iVERVE)

“…The specific feedback from participants related to their experience during this pilot study has reiterated the importance of testing the effectiveness of the self-management support programme earlier in the stroke recovery continuum, and over a longer period. We have used this feedback to modify the protocol for our fully powered RCT, 51 52 As a consequence of the feedback received by participants on their experience, the frequency of messages per goal is similar to the Phase I trial, but there is the option for participants to select up to five goals. Messages are being sent via SMS or email, depending on personal preference.…”

“…The specific feedback from participants related to their experience during this pilot study has reiterated the importance of testing the effectiveness of the self‐management support programme earlier in the stroke recovery continuum, and over a longer period. We have used this feedback to modify the protocol for our fully powered RCT, 51 currently being undertaken within Australia. The Phase II and III trials are designed to provide the intervention for 12 weeks commencing 7–14 days after discharge from an acute care hospital.…”

Care Transition Interventions to Improve Stroke Outcomes: Evidence Gaps in Underserved and Minority Populations

“…The ReCAPS trial (Recovery-Focused Community Support to Avoid Readmissions and Improve Participation After Stroke) 93 is currently in progress after the successful development and feasibility testing of a co-designed novel electronic communication technology intervention to support the transition to home after an acute stroke. 83,94,95 The eHealth intervention is designed to provide a range of messages sent via SMS or email to support person-centered goal attainment, self-management support and secondary stroke prevention.…”