Abstract
Abstract
Background
Each year, approximately 100,000 individuals receive home health services after a stroke. Evidence has shown the benefits of home-based stroke rehabilitation, but little is known about resource-efficient ways to enhance its effectiveness, nor has anyone explored the value of leveraging low-cost home health aides (HHAs) to reinforce repetitive task training, a key component of home-based rehabilitation. We developed and piloted a Stroke Homehealth Aide Recovery Program (SHARP) that deployed specially trained HHAs as “peer coaches” to mentor frontline aides and help individuals recovering from stroke increase their mobility through greater adherence to repetitive exercise regimens. We assessed the feasibility of SHARP and its readiness for a full-scale randomized controlled trial (RCT). Specifically, we examined (1) the practicability of recruitment and randomization procedures, (2) program acceptability, (3) intervention fidelity, and (4) the performance of outcome measures.
Methods
This was a feasibility study including a pilot RCT. Target enrollment was 60 individuals receiving post-stroke home health services, who were randomized to SHARP + usual home care or usual care only. The protocol specified a 30-day intervention with four planned in-home coach visits, including one joint coach/physical therapist visit. The primary participant outcome was 60-day change in mobility, using the performance-based Timed Up and Go and 4-Meter Walk Gait Speed tests. Interviews with participants, coaches, physical therapists, and frontline aides provided acceptability data. Enrollment figures, visit tracking reports, and audio recordings provided intervention fidelity data. Mixed methods included thematic analysis of qualitative data and quantitative analysis of structured data to examine the intervention feasibility and performance of outcome measures.
Results
Achieving the 60-participant enrollment target required modifying participant eligibility criteria to accommodate a decline in the receipt of HHA services among individuals receiving home care after a stroke. This modification entailed intervention redesign. Acceptability was high among coaches and participants but lower among therapists and frontline aides. Intervention fidelity was mixed: 87% of intervention participants received all four planned coach visits; however, no joint coach/therapist visits occurred. Sixty-day follow-up retention was 78%. However, baseline and follow-up performance-based primary outcome mobility assessments could be completed for only 55% of participants.
Conclusions
The trial was not feasible in its current form. Before progressing to a definitive trial, significant program redesign would be required to address issues affecting enrollment, coach/HHA/therapist coordination, and implementation of performance-based outcome measures.
Trial registration
ClinicalTrials.gov, NCT04840407. Retrospectively registered on 9 April 2021
Publisher
Springer Science and Business Media LLC