Abstract
OBJECTIVES: To evaluate effects of health extension workers-led home-based multicomponent intervention on blood pressure change in hypertensive patients in rural districts of northwest Ethiopia. DESIGN: Two-arm cluster randomised controlled trial was conducted. PARTICIPANTS: Hypertensive patients' age ≥25 years were included. 20 clusters or kebeles with 456 participants were randomly assigned to the intervention group (10 clusters with 228 participants) and the control group (10 clusters with 228 participants). INTERVENTIONS: Participants in the intervention kebeles received health extension workers-led home-based multicomponent interventions every other month for 40-60 min for 9 months. MAIN OUTCOME MEASURES: The primary outcomes were the differences in mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) changes from baseline between patients in the intervention and control groups. Intention-to-treat analysis was used for the primary analyses. Linear mixed effect model was used to evaluate the intervention's effect on change in mean SBP and DBP. Effect sizes of mean difference and relative benefit increase were used. RESULTS: At 9 months, the mean SBP decreased by 15.8 mm Hg (95% CI: 13.5, 18.1) in the intervention and 10.8 mm Hg (95% CI: 8.7, 12.9) in the control groups; with a 5.0 mm Hg (95% CI: 1.9, 8.1) greater reduction in the intervention group. The mean DBP decreased by 12.1 mm Hg (95% CI: 10.6, 13.5) in the intervention and 8.4 mm Hg (95% CI: 7.0, 9.8) in the control group. The proportion of optimal blood pressure control was higher in the intervention group (45.8%) than the control group (28.2%) with percentage difference of 17.6% (95% CI: 8.5, 26.7). CONCLUSIONS: Health extension workers-led home-based multicomponent intervention has resulted significant reduction of blood pressure and achieved a higher proportion of optimal blood pressure control. This strategy is effective, but further research is needed to determine its cost effectiveness for scaling up and integrating in primary care settings. TRIAL REGISTRATION: The trial is registered with Pan African clinical trial registry (PACTR202102729454417).