Community Health Worker-Led Church-Based Intervention for Eliminating Cardiovascular Health Disparities in African Americans - Project Summary/Abstract Louisiana residents, especially African Americans, bear a disproportionately high burden of atherosclerotic cardiovascular disease (ASCVD). In the proposed cluster randomized trial, we will test whether a multifaceted strategy for implementing the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease will reduce cardiovascular health disparities in African Americans from 42 black churches in New Orleans and Bogalusa, Louisiana. The proposed study will utilize an effectiveness-implementation hybrid design to 1). test the effectiveness of a community health worker (CHW)-led church-based multifaceted implementation strategy for improving cardiovascular health over 18 months among African Americans at high risk for ASCVD, and 2). assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, penetrance, cost- effectiveness, and sustainability) of the multifaceted strategy simultaneously. The RE-AIM framework has guided the development and evaluation of the multifaceted implementation strategy, which includes CHW-led health coaching on lifestyle changes and medication adherence; church-based exercise and weight loss programs; self-monitoring of physical activity, blood pressure (BP), and glucose; and provider education and engagement. The primary effectiveness outcome is the difference in the proportion of participants having ≥4 ideal or improved cardiovascular health metrics (CHMs), defined as a healthy diet score of 4-5 components or increase of 2 components from baseline; 150 minutes/week moderate- or 75 minutes/week vigorous-intensity physical activity or a combination; never smoking or quitting ≥6 months ago; body mass index <25 kg/m2 or weight loss ≥10 pounds; A1c <7.0% (or <8.0% with complications); use of statin therapy as appropriate; and BP <130/80 mmHg or systolic BP reduced by ≥10 mmHg. Our study has 90% statistical power to detect an absolute difference of 15% in the primary effectiveness outcome at 18 months using a 2-sided significance level of 0.05. In the planning phase, we will work with stakeholders to ensure the multifaceted implementation strategy is responsive to African American community needs; we will identify 42 black churches as research partners and conduct a health needs assessment; and we will develop the study protocol and obtain approval from the NIH, DSMB, and IRB. In the implementation phase, we will recruit 1,050 African American participants (25 per church) aged ≥40 years who have <4 ideal CHMs and randomly assign 21 churches to intervention and 21 to control; we will implement the multifaceted intervention program; we will follow-up participants and collect data on effectiveness and implementation outcomes at 6, 12, and 18 months; we will evaluate the sustainability of the intervention in a 6-month post-intervention study; and we 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 cardiovascular health disparities in high-burden populations in the US.
