ENGAGE program shows feasibility and preliminary signal for participation after chronic stroke in pilot trial
This was a phase 2a, single-arm, multi-site pilot study evaluating the feasibility of the ENGAGE intervention for community-dwelling survivors of chronic stroke. The 6-week program involved 12 in-person and 9 virtual sessions co-facilitated by stroke survivor peer mentors and occupational therapy providers. Of 42 consented participants, 30 started the intervention, with 27 completing it (90% retention). Active engagement was 85%, and 87% reported very high satisfaction. No injuries or injurious falls were reported.
The primary outcome was feasibility, including retention, engagement, acceptability, satisfaction, and safety. A secondary outcome measured within-group change in community and social participation using the PROMIS Ability to Participate in Social Roles and Activities Scale. Analysis showed a medium within-group effect size (d = 0.38), though the 95% confidence interval was wide and included zero (-0.11, 0.94).
Key limitations stem from the pilot design: there was no comparator group, the sample size was small (n=30 starting intervention), and the confidence interval for the participation effect includes zero, indicating statistical uncertainty. The study did not report on serious adverse events, discontinuations, tolerability, follow-up duration, or funding/conflicts.
For practice, this pilot provides preliminary evidence that a peer-mentor and therapist co-facilitated program is feasible, acceptable, and safe in this population, with a signal for improving participation. However, the single-arm design and small sample preclude conclusions about efficacy or causality. The results support proceeding to a controlled trial to rigorously test the intervention's effectiveness.