Background: Process evaluation of pilot trials are an important step in translating findings to both definitive trials and clinical practice.
Aims: To conduct a process evaluation of the ENAbLE pilot: a 6-month, telehealth delivered physical activity and diet randomised controlled trial.
Methods: Mixed methods using the RE-AIM framework to assess the reach, effect, adoption, implementation, and maintenance of the ENAbLE pilot. Data sources included recruitment and session data, clinical outcomes, session audit, participant survey, interview, and intervention therapist focus groups. Quantitative data were analysed using descriptive statistics and linear regression models adjusted for time. Qualitative data were thematically analysed using nVivo software.
Results: Reach: Participants (n = 40) differed from the Australian stroke survivor population (were younger, walked independently, lived in major centres, and were not affected by speech or communication disorders). Effect: Significant between group estimated effects in self-reported physical activity [744 minutes (95% CI: 73 to 1415)], Mediterranean diet score [3.2 points (95% CI: 2.0 to 4.4 points)] and diet quality [4.6 points (95% CI: 0.5 to 8.8 points)] during the intervention. Blood pressure improved but did not reach significance. Quality of life was mostly unchanged. Adoption: Intervention acceptability and completion rates were high (n = 36, 90%) suggested modifications were a comprehensive platform, workflow and training prior and support post-intervention. Implementation: Session fidelity was high (88% - 100%) with high frequency/variety of behaviour change techniques. Maintenance: Significant improvements in self-reported physical activity and Mediterranean diet score remained at 12-months however, effect was diluted across most other variables.
Conclusion: The ENAbLE pilot is an acceptable, feasible, and effective program for engaging stroke survivors in activities designed to lower recurrent stroke risk. Participants and trial staff suggest modification to sustain effect and move the program into a larger powered trial.