BMJ Open. 2026 Sep 30;16(9):e123012. doi: 10.1136/bmjopen-2026-123012.
ABSTRACT
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.
PMID:42816085 | DOI:10.1136/bmjopen-2026-123012