Cardiovascular risk factor reduction by community health workers in rural India: A cluster randomized trial

Background There is a need to identify and test low-cost approaches for cardiovascular disease (CVD) risk reduction that can enable health systems to achieve such a strategy. Objective Community health workers (CHWs) are an integral part of health-care delivery system in lower income countries. Our aim was to assess impact of CHW based interventions in reducing CVD risk factors in rural households in India. Methods We performed an open-label cluster-randomized trial in 28 villages in 3 states of India with the household as a unit of randomization. Households with individuals at intermediate to high CVD risk were randomized to intervention and control groups. In the intervention group, trained CHWs delivered risk-reduction advice and monitored risk factors during 6 household visits over 12 months. Households in the non-intervention group received usual care. Primary outcomes were a reduction in systolic BP (SBP) and adherence to prescribed BP lowering drugs. Results We randomized 2312 households (3261 participants at intermediate or high risk) to intervention (1172 households) and control (1140 households). At baseline prevalence of tobacco use (48.5%) and hypertension (34.7%) were high. At 12 months, there was significant decline in SBP (mmHg) from baseline in both groups- controls 130.3 +/- 21 to 128.3 +/- 15; intervention 130.3 +/- 21 to 127.6 +/- 15 (P< .01 for before and after comparison) but there was no difference between the 2 groups at 12 months (P= .18). Adherence to antihypertensive drugs was greater in intervention vs control households (74.9% vs 61.4%, P= .001). Conclusion A 12-month CHW-led intervention at household level improved adherence to prescribed drugs, but did not impact SBP. To be more impactful, a more comprehensive solution that addresses escalation and access to useful therapies is needed.