Rationale and design of a cluster-randomized controlled trial to evaluate the effects of a community health worker-based program for cardiovascular risk factor control in India.

BACKGROUND: The increasing burden of cardiovascular disease (CVD) in low- and middle-income countries is largely driven by the increasing prevalence of hypertension, diabetes, and tobacco use. We hypothesize that the utilization of community health workers (CHWs) to screen for and manage these 3 determinants of CVD in an integrated manner would be an effective approach to favorably affecting public health.

METHODS: We have designed and set up the infrastructure to implement a 2-year community-based cluster randomized controlled trial in an underserved region of West Bengal, India. Participants include around 1200 adults, aged between 35 and 70 years, with ≥1 cardiovascular risk factor. They are recruited through home-based screening into a total of 12 clusters, which are randomized to either a control or intervention arm before screening. After the screening, CHWs follow up with participants enrolled in the intervention arm for a period of 2 years through home visits. The control arm receives usual care in the community. The CHW arm follows a behavioral strategy focused on modifying the individual's lifestyle, increasing knowledge of CVD, promoting smoking cessation, increasing physician-seeking behavior, and promoting medication adherence. The main project office is based in Cleveland, OH, at University Hospitals/CWRU, and the local site office is located in Dalkhola, West Bengal, at a local nonprofit set up for the study. Institutional review board approval was obtained both in Cleveland as well as in India.

OUTCOME EVALUATION: The 2-year primary outcome of the study is the absolute reduction in systolic blood pressure among hypertensive participants, absolute reduction in fasting blood glucose among diabetic participants, and absolute reduction in average number of cigarettes smoked per day among smokers.

DISCUSSION: We believe that this study infrastructure serves as a useful model for international collaboration. It builds on unique local resources, attends to important domestic requirements, and will ultimately provide an evidence-based approach that will help manage the increasing burden of CVD worldwide.