Effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk: study protocol for a cluster-randomized trial.

BACKGROUND: More than 50% of patients with type 2 diabetes have hypertension in Uganda. Diabetic patients with elevated systolic blood pressure experience higher all-cause mortality and cardiovascular events compared with normotensive diabetic individuals, hence escalating resource utilization and cost of care. The aim of this study is to determine the effect of a nurse-led lifestyle choice and coaching intervention on systolic blood pressure among type 2 diabetic patients with a high atherosclerotic cardiovascular risk. METHODS: This is a cluster-randomized study comprising two arms (intervention and non-intervention-control arm) with four clusters per arm with 388 diabetic patients with a high predicted 10-year atherosclerotic cardiovascular risk. The study will be implemented in 8 health facilities in Uganda. The intervention arm will employ a nurse-led lifestyle choice and coaching intervention. Within the intervention, nurses will be trained to provide structured health education, protocol-based hypertension management, and general atherosclerotic cardiovascular risk factor management, 24-h phone calls, and 2-monthly text messaging. The control group will be constituted by the usual care. The primary outcome measure is the mean difference in systolic blood pressure between the intervention and usual care groups after 6 months. The study is designed to have an 80% statistical power to detect an 8.5-mmHg mean reduction in systolic blood pressure from baseline to 6 months. The unit of analysis for the primary outcome is the individual participants. To monitor the effect of within-cluster correlation, generalized estimating equations will be used to assess the changes over time in systolic blood pressure as a continuous variable. DISCUSSION: The data generated from this trial will inform change in the policy of shifting task of screening of hypertension and atherosclerotic cardiovascular disease from doctors to nurses. TRIAL REGISTRATION: Pan African Trials Registry PACTR 202001916873358 . Registered on 6 October 2019.