Community Health Worker-Led Church-Based Intervention for Eliminating Cardiovascular Health Disparities in African Americans

社区卫生工作者主导的教会干预措施，旨在消除非裔美国人的心血管健康差异

• 批准号: 10767518
• 负责人: Keith Copelin Ferdinand
• 金额: $ 129.82万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-10 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10767518
• 关键词: Address; Adoption; Adult; African American; African American population; Atherosclerosis; Black church; Blood Pressure; Body Weight decreased; Body mass index; Cardiovascular Diseases; Caring; Cause of Death; Cholesterol; Church; Clinical; Clinical Research; Clinical Trials Data Monitoring Committees; Cluster randomized trial; Communities; Community Health Aides; Control Groups; Cost Effectiveness Analysis; Data; Development; Diet; Education; Educational Materials; Effectiveness; Elements; Ensure; Evaluation; Exercise; Feedback; Follow-Up Studies; General Population; Glucose; Goals; Guidelines; Health; Health Personnel; Health Promotion; Health behavior; Healthcare Systems; Institutional Review Boards; Intention; Intervention; Intervention Studies; Knowledge; Life Style; Louisiana; Manuals; Medical; Monitor; Needs Assessment; Outcome; Outcome Study; Participant; Penetrance; Phase; Physical activity; Population; Prevention Guidelines; Primary Prevention; Procedures; Process Measure; Protocols documentation; Provider; Public Health; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Readiness; Recommendation; Research; Risk Factors; Side; Smoking; Social Environment; Testing; Training; Unhealthy Diet; United States National Institutes of Health; Visit; Weight; Work; aged; atherosclerosis risk; blood pressure reduction; cardiovascular disorder prevention; cardiovascular disorder risk; cardiovascular health; community setting; cost; cost effectiveness; effectiveness outcome; effectiveness testing; effectiveness/implementation design; follow-up; geographic disparity; good diet; group intervention; health care availability; health disparity; high risk; implementation evaluation; implementation outcomes; implementation process; implementation strategy; improved; inner city; intervention program; medication compliance; member; multi-component intervention; never smoking; patient oriented; pilot test; post intervention; primary outcome; racial disparity; recruit; rural African American; scale up; socioeconomics; treatment as usual; unhealthy lifestyle; vigorous intensity; weight loss program

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.

项目总结/文摘