Community-based intervention for blood pressure reduction in Nepal (COBIN trial): study protocol for a cluster-randomized controlled trial

BACKGROUND: Hypertension contributes to a significant burden of cardiovascular disease in low- and middle-income countries; however, responses are inadequate because of a lack of conclusive evidence on population-based approaches to hypertension control. METHODS/DESIGN: The objective of the present study is to determine the effect of family-based home health education and blood pressure monitoring by trained female community health volunteers. The primary outcome is change in mean systolic blood pressure. A community-based, open-masked, two-armed, cluster-randomized trial will be conducted in Lekhnath Municipality of Nepal. The municipality is divided into 15 administrative clusters. Randomization will be conducted for 14 clusters: 7 for the intervention arm and 7 for the control arm. The participants were recruited from a prevalence study conducted earlier. On the basis of population proportion size, 929 individuals for the intervention group and 709 individuals for the control group will participate in the study. Due to the nature of the study, study participants are not compensated or insured. As part of the blood pressure intervention, trained female community health volunteers will conduct home visits for health education and blood pressure measurement. The primary outcomes will be modeled by using multiple linear regression analysis. DISCUSSION: This project will be an investigation of a community-based intervention to control blood pressure in countries with limited resources. The study will provide detailed information on the burden of blood pressure and also whether treatment targets are being met. Moreover, evidence will be provided on the future role of female community health volunteers for hypertension management in Nepal. The lessons learned from this study may also be replicated in other rural areas of Nepal and elsewhere in the world with similar settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT02428075. Registered on 23 April 2015. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-016-1412-3) contains supplementary material, which is available to authorized users.