Effect of health extension workers led home-based intervention on hypertension management in Northwest Ethiopia, 2021: study protocol for a cluster randomised controlled trial

INTRODUCTION: Although hypertension is highly prevalent in Ethiopia, it is poorly diagnosed, treated and controlled. Poor access to care and a shortage of healthcare providers are major barriers. This study aims to evaluate the effects of health extension workers' led home-based intervention on hypertension management in patients with hypertension in rural districts of northwest Ethiopia. METHODS AND ANALYSIS: A two-arm cluster randomised controlled trial will be conducted among 456 hypertensive patients. Adults aged ≥25 years who have a diagnosis of hypertension both in the home-based hypertension screening study and at another measurement prior to recruitment will be eligible for the study. Randomisation will be done at the kebele level. In the intervention clusters, trained health extension workers will provide home-based intervention for hypertensive patients every 2 months for 9 months. The primary outcomes of the trial will be clinical linkage and blood pressure changes, whereas the secondary outcomes will be lifestyle modification, medication adherence and blood pressure control. Intention-to-treat analysis will be used for all primary analyses. A linear mixed-effect regression model will be used to model the change in blood pressure, while a mixed effect logistic regression model will be used to evaluate the intervention's effect on the binary outcomes. Effect sizes such as mean difference for the continuous outcomes and relative risk, attributable risk and population attributable risk for binary outcomes will be used. All statistical analyses are two sided and a p<0.05 will be used. ETHICS AND DISSEMINATION: This study has been approved by institutional review board of the University of Gondar (Ref. No: V/P/RCS/05/2293/2020). The district's health office will grant permission for cluster randomisation, and each participant will provide written informed consent for participation. The findings will be presented at scientific conferences and published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: PACTR202102729454417.