Effect of a community-based intervention for cardiovascular risk factor control on stroke mortality in rural Gadchiroli, India: a cluster-randomised controlled trial

<ns5:p>Background Stroke is the second leading cause of death globally. We tested whether it was feasible to deliver a community-based intervention package for prevention of stroke and, whether such an intervention would reduce stroke mortality in a rural underserved community in central India. Methods In this two-arm, parallel group, open label, cluster randomised controlled trial, 64 villages were randomly assigned with 1:1 allocation to the control and the intervention arm in a demographic surveillance site. The intervention was delivered for 3.5 years. It included community-based screening for hypertension, diabetes and stroke among individuals ≥ 50 years of age by trained community health workers followed by village-based treatment by an outreach physician, awareness generation and active follow up. In the control arm, households were provided information on the ill effects of tobacco and steps to quit it. Cause of death was ascertained on all deaths using verbal autopsies by physician coders who were blinded to the treatment allocation. Results There were 7671 individuals in the control arm and 8255 in the intervention arm who were ≥ 50 years of age. In the intervention arm, out of 8255 eligible individuals, 8026 were screened and 2793 were diagnosed with hypertension, 317 with diabetes and 182 with stroke and those with these three conditions received the intervention. The stroke mortality rate per 100,000 person-years in the last 2.5 years of the intervention, which was the primary outcome of the trial, was comparable in the intervention (416.7) and the control arm (484.9) (adjusted hazard ration [HR] 0.84, 95 % confidence interval [0.62,1.12]; p = 0.23). Important limitations include limited access to brain imaging and lipid profile measurements. Conclusions In this under resourced rural community in central India, a community-based intervention for stroke risk reduction did not reduce stroke mortality over the final 2.5 years of the trial. However, the trial intervention was acceptable and led to improved medication compliance, blood pressure control and awareness about stroke. Trial registration The trial was registered at the Clinical Trials Registry of India: CTRI/2015/12/006424.</ns5:p>