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 (NPHW) and supported by mobile (m-) health technologies (tablets programmed with decision and counselling support software); (2) initiation of evidence-based cardiovascular (CV) medications; and (3) treatment supporters to optimize long-term medication and lifestyle adherence. The Hypertension (HT) Phase study objective is to evaluate whether the intervention programme can substantially improve Framingham Risk Score (FRS) at 1 year. The HT Phase will also address associated CV risk factors, such that important reductions in CVD events can be evaluated if the study expands to the CVD Phase (6 years).
Cluster randomized controlled, open label trial.
Primary outcome HT Phase: The mean difference in FRS change from baseline to 12 months between the intervention and control communities
J-D Schwalm, Salim Yusuf
Martha Hernandez, Dawn Ashforth, Gian Ferrera, Hadi Musa
Schwalm JR, McCready T, Lamelas P, Musa H, Lopez-Jaramillo P, Yusoff K, Attaran A, Lamelas, P, Camacho P, Majid F, Bangdiwala S, Thabane L, Islam S, McKee M, Yusuf, S. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet. 2 September 2019. doi:10.1016/S0140-6736(19)31949-X
Schwalm JR, McCready T, Lamelas P, Musa H, Lopez-Jaramillo P, Yusoff K, McKee M, Camacho PA, Lopez-Lopez J, Majid F, Thabane L, Islam S, Yusuf S. Rationale and design of a cluster randomized trial of a multifaceted intervention in people with hypertension: The Heart Outcomes Prevention and Evaluation 4 (HOPE-4) Study. Am Heart J 2018; 203: 57-66.
Khan M, Lamelas P, Musa H, Paty J, McCready T, Nieuwlaat R, Ng E, Lopez-Jaramillo P, Lopez-Lopez J, Yusoff K, Majid FA, Ng KK, Garis L, Onuma O, Yusuf S, Schwalm JD. Development, Testing, and Implementation of a Training Curriculum for Nonphysician Health Workers to Reduce Cardiovascular Disease. Glob Heart 2018 Jan 10. pii: S2211-8160(17)30149-7.