Performing lifestyle changes and reducing stroke risk: a process evaluation of a stroke prevention intervention

Objective To examine the implementation process, mechanisms of change and contextual influences of a stroke prevention intervention. Design A process evaluation following the UK Medical Research Council’s process evaluation framework was conducted alongside a randomised controlled trial (RCT). Setting The intervention was conducted in Swedish primary healthcare. Participants Persons at high risk of stroke participating in the Make My Day, a 10-week group-based intervention (n=122) and healthcare professionals delivering the intervention (n=10). Methods Quantitative data from logbooks, surveys and app registrations, and qualitative data from interviews, logbooks and reflexive fieldnotes were collected across five cohorts. Data were analysed separately and integrated using a convergent mixed-methods approach. Results Fidelity varied; overall adherence to the study manual and programme content was good, while fidelity to specific session activities and session attendance varied, with a mean of 3.6 (SD 2.2) out of 6. Recruitment successfully reached individuals at high risk of stroke, but reaching a vulnerable population was challenging. Realistic, activity-focused goal setting emerged as the most perceived valued mechanism of change. Engaging everyday activities supported sustainable change when a sense of belonging was established. The group served as both a facilitator and a barrier to lifestyle change. The mobile app offered opportunities but faced usability challenges. Healthcare professionals’ delivery of the intervention was expressed as central for the change. Conclusions This study demonstrates how fidelity, facilitation and contextual conditions shape the functioning of a complex lifestyle intervention. Supporting healthcare professionals with adequate preparation and pedagogical skills is critical to optimising the delivery and outcomes of stroke prevention interventions in primary healthcare. Trial registration number NCT05279508 .