Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)

Louisiana residents, especially African Americans, bear a disproportionately high burden of hypertension and cardiovascular disease (CVD). In the Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial, the investigators will compare the impact of two implementation strategies - a CHW-led multifaceted strategy and a group-based education strategy - for delivering interventions recommended by the 2017 American College of Cardiology (ACC) and the American Heart Association (AHA) hypertension clinical guidelines on implementation and clinical effectiveness outcomes in predominantly Black community members over 18 months. The BLESSED study utilizes an effectiveness-implementation hybrid design to: (1). test the effectiveness of a CHW-led church-based multifaceted implementation strategy for reducing estimated CVD risk over 18 months among African American church community members at high risk for CVD, and (2). assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, penetrance, cost-effectiveness, and sustainability) simultaneously. The Exploration, Preparation, Implementation, Sustainment (EPIS) framework has guided the development and evaluation of the multifaceted implementation strategy, which includes CHW-led health coaching on lifestyle changes and medication adherence; healthcare delivery in community; church-based exercise and weight loss programs; self-monitoring of blood pressure (BP); and provider education and engagement. The CHW-led church-based intervention will provide strong social support and tackle multiple social determinants of CVD disparities. The primary clinical effectiveness outcome is the difference in mean change of systolic blood pressure (SBP) from baseline to 18 months between intervention and control groups. The primary implementation outcome is a fidelity summary score for key implementation strategy components to the CHW-led church-based multifaceted implementation strategy assessed at the participant levels. This study has 90% statistical power to detect group differences in mean SBP change of 5.8 mm Hg over 18 months using a 2-sided significance level of 0.05. The investigators will recruit 1,176 participants (28 per church) who are aged ≥18 years with systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mm Hg, and randomly assign 21 churches to intervention and 21 to control; the investigators will implement the multifaceted intervention program; the investigators will follow-up participants and collect data on effectiveness and implementation outcomes at 6, 12, and 18 months; the investigators will evaluate the sustainability of the intervention at 6 months post-intervention; and the investigators will perform intention-to-treat analyses and disseminate and scale-up the proven-effective implementation strategy. The proposed study will generate evidence on the effectiveness, implementation, and sustainability of the multifaceted intervention aimed at eliminating CVD disparities in African American populations in the US.

• Difference in the proportion of patients with controlled BP between intervention and control groups [Срок оценки: Measured from baseline to 18 months]
• Difference in mean change of diastolic BP [Срок оценки: Measured from baseline to 18 months]
• Side effects of medications and adverse events [Срок оценки: Measured from baseline to 18 months]
• Cost-effectiveness [Срок оценки: Measured from baseline to 18 months]
• Acceptability [Срок оценки: Measured from baseline to 18 months]
• Adoption (Churches) [Срок оценки: Measured from baseline to 18 months]
• Adoption (Providers) [Срок оценки: Measured from baseline to 18 months]
• Appropriateness [Срок оценки: Measured from baseline to 18 months]
• Feasibility to participant, community health worker, provider and churches [Срок оценки: Measured from baseline to 18 months]
• Exercise Session Fidelity (community health worker-led strategy group) [Срок оценки: Measured at 6, 12, and 18 months]
• Fidelity of Group Health Education Session [Срок оценки: Measured at 6, 12, and 18 months]
• Nutrition Education Session Fidelity (community health worker-led strategy group) [Срок оценки: Measured at 6, 12, and 18 months]