Primary Prevention of Stroke in Rural India by Empowering the Frontline Health Workers - A Cluster Randomized Controlled Trial

Background: Stroke is a leading cause of mortality and disability worldwide, disproportionately affecting low- and middle-income countries (LMICs). In India, delayed recognition of warning signs and limited primary prevention strategies contribute to poor outcomes. Frontline health workers (FLWs) are uniquely positioned to identify risk factors and deliver community-based interventions, yet structured training in stroke prevention is limited. Objectives: The primary objective is to assess whether the Adult Stroke Prevention Module (ASPM) improves FLW skill delegation and competency compared to the Nigerian Educational Intervention Module (NEIM). Secondary objectives include evaluating changes in community participants’ modifiable risk factors, knowledge retention, and adherence to preventive behaviors. Methods: This cluster-randomized controlled trial will be conducted across eight community clusters in Wardha district, Maharashtra. Clusters will be randomized using a computer-generated sequence by an independent statistician, with allocation concealment maintained. Stratification will be applied based on population size and FLW density. FLWs will be randomized to ASPM (structured four-session training plus video module) or NEIM (translated video-based education with counseling). Adults aged 40–60 years identified by FLWs will undergo baseline and follow-up assessments at 3, 6, and 9 months, including blood pressure, glucose, cholesterol, waist-to-hip ratio, lifestyle habits, and stress levels. The primary endpoint is FLW skill delegation competency, measured using a validated checklist. Secondary outcomes include biometric and behavioral changes among community participants. Sample size is calculated assuming an effect size of 0.30, intracluster correlation coefficient (ICC) of 0.02, alpha of 0.05, power of 80%, and attrition of 15%, requiring approximately 100 FLWs and 400 community participants. Data will be analyzed using mixed-effects regression models with cluster random effects, baseline adjustment, repeated measures, and multiple imputation for missing data. Results: The trial has been registered in the Clinical Trial Registry of India (CTRI/2025/05/086446). Training materials and video modules have been finalized, and a pilot study with 20 FLWs is yet to be completed to refine tools and procedures. Recruitment is projected to begin in May 2026, with data collection expected to conclude by March 2027. Conclusions: This study will provide evidence on the comparative efficacy of ASPM versus NEIM in enhancing FLW-led stroke prevention. Findings are expected to inform scalable, technology-driven strategies for primary prevention in LMICs, strengthen community health systems, and contribute to policy frameworks aimed at reducing the growing burden of stroke. Trial Registration: CTRI/2025/05/086446 (Registered May 6, 2025)