Effect of a community-based intervention for cardiovascular risk factor control on stroke mortality in rural Gadchiroli, India: study protocol for a cluster randomised controlled trial
Abstract Background Stroke has emerged as a leading cause of death in rural India. However, well tested healthcare interventions to reduce stroke mortality in rural under-resourced settings are lacking. The aim of this study is to evaluate the effect of a community-based preventive intervention on stroke mortality in rural Gadchiroli, India. Methods The study is a two-arm, parallel group, cluster randimised controlled trial where 32 villages each will be randomised to the intervention and the enhanced usual care (EUC) arm. In the intervention arm, individuals ≥ 50 years of age will be screened for hypertension, diabetes and stroke by trained Community Health Workers (CHWs). Screen positive individuals will be referred to a mobile outreach clinic which will visit intervention villages. A physician in the clinic will confirm the diagnosis, provide guideline-based treatment and follow up patients at periodic intervals. The CHWs will make home visits once a month to ensure medication compliance and counsel patients to reduce salt consumption and quit tobacco and alcohol. In the EUC arm, households will be provided information on the ill effects of tobacco and steps to quit it. Individuals from both the arms will have access to government’s national programme for prevention and control of non-communicable diseases where treatment for hypertension, diabetes and stroke is available at the primary health centres (PHCs). The intervention will be implemented for 3.5 years. The primary outcome will be reduction in stroke mortality in the last 2.5 years of the intervention. Discussion This trial will provide important information regarding the feasibility and effect of a community-based preventive intervention package on stroke mortality in a rural under-resourced setting and can inform India’s non-communicable diseases prevention and control programme. If successful, such an intervention can be scaled up in rural regions of India and other countries.