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

项目摘要/摘要 路易斯安那州居民，尤其是非裔美国人，承受着不成比例的动脉粥样硬化负担 心血管疾病(ASCVD)。在拟议的整群随机试验中，我们将测试是否有多方面的 实施《2019年ACC/AHA心血管疾病一级预防指南》的战略 将减少来自新奥尔良42座黑人教堂的非裔美国人的心血管健康差距 路易斯安那州博加卢萨。拟议的研究将利用有效性-实施混合设计来1)。测试 社区卫生工作者(CHW)领导的基于教会的多方面实施策略的有效性 用于在18个月内改善ASCVD高危非裔美国人的心血管健康，以及2)。 评估执行成果(可接受性、适应性、采纳性、可行性、保真度、透明度、成本-- 有效性和可持续性)同时兼顾多方面战略。RE-AIM框架具有 指导制定和评估多方面的执行战略，其中包括由卫生和社会事务部牵头的战略 关于改变生活方式和服药依从性的健康指导；基于教堂的锻炼和减肥 计划；自我监测体力活动、血压(BP)和血糖；以及提供者教育和 订婚。主要的有效性结果是患有≥4的参与者比例的差异 理想或改进的心血管健康指标(CHM)，定义为4-5种成分的健康饮食得分或 比基线增加2个组成部分；150分钟/周中等强度-或75分钟/周剧烈强度 体力活动或两者兼而有之；6个月前从不吸烟或戒烟；体重指数&lt；25公斤/平方米或 体重减轻≥10磅；A1c&lt；7.0%(或有并发症的8.0%)；适当使用他汀类药物；以及 血压130/80毫米汞柱或收缩压降低≥10毫米汞柱。我们的研究有90%的统计能力来检测 18个月时初次有效结果的绝对差异为15%，采用双侧显著性 0.05的水平。在规划阶段，我们将与利益相关者合作，确保多方面的实施 战略是对非裔美国人社区的需求做出回应；我们将确定42个黑人教堂作为研究 并进行健康需求评估；我们将制定研究方案并获得批准 来自NIH、DSMB和IRB。在实施阶段，我们将招募1050名非洲裔美国人参与者 (每个教堂25名)年龄≥40岁，拥有&lt；4个理想的CHM，并随机分配21个教堂进行干预 和21个对照；我们将实施多方面干预计划；我们将跟踪调查参与者和 收集6个月、12个月和18个月的有效性和实施结果的数据；我们将评估 在为期6个月的干预后研究中干预的可持续性；我们将进行意向治疗 分析、传播和扩大被证明有效的实施战略。拟议的研究将 为多方面干预的有效性、实施和可持续性提供证据 旨在消除美国高负担人群的心血管健康差距。

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.