Heart Outcomes Prevention and Evaluation 4 (HOPE-4)
To develop, implement and evaluate an evidence-based, contextually appropriate programme for cardiovascular disease (CVD) risk assessment, treatment and control involving: (1) simplified algorithms implemented by non-physician health workers (2) single pill, fixed dose, combination therapy (Polycap) and (3) treatment supporters and e-health technology to optimize long-term medication and lifestyle adherence. This programme has the potential to reduce risk of CV deaths and CV events by 35% over approximately 6 years, as compared to usual care. The HT Phase study objective is to evaluate whether the intervention programme can substantially reduce blood pressure (BP) levels and improve hypertension (HT) control at 1 year. The HT Phase will also address associated CV risk factors, such that important reductions in CVD and estimated CVD risk can be evaluated when the study expands to the CVD Phase (6 years).
Cluster randomized controlled, open label trial.
Primary Outcome HT Phase: The mean difference in change in systolic BP between the intervention and control communities at 12 months.
Primary Outcome CVD Phase: Difference in major CV events [CV death, MI, stroke, CHF, CV hospitalizations (e.g. AF, unstable or new onset angina, CHF, arterial revascularization), and end-stage renal disease] at 6 years.
J-D Schwalm, Salim Yusuf
Eleanor Ng, Hadi Musa, Victoria Yabas