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基于教会的干预措施，旨在消除非裔美国人的心血管健康差异

• 批准号: 10477390
• 负责人: Jiang He
• 金额: $ 120.8万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10477390
• 关键词: Address; Adoption; Adult; African American; African American population; Atherosclerosis; Blood Pressure; Body Weight decreased; Body mass index; Cardiovascular Diseases; 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; Effectiveness; Elements; Ensure; Evaluation; Exercise; Feedback; Follow-Up Studies; General Population; Glucose; Goals; Guidelines; Health; Health Personnel; Health Promotion; Health behavior; Health education; 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; Research; Risk Factors; Side; Smoking; Social Environment; Testing; Time; Training; Unhealthy Diet; United States National Institutes of Health; Ursidae Family; Visit; Weight; Work; aged; atherosclerosis risk; base; blood pressure reduction; cardiovascular disorder prevention; cardiovascular disorder risk; cardiovascular health; care providers; community setting; cost; cost effectiveness; design; effectiveness implementation study; effectiveness outcome; effectiveness testing; 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/摘要 路易斯安那州的居民，特别是非洲裔美国人，承受着不成比例的高负担动脉粥样硬化 心血管疾病（ASCVD）。在拟议的集群随机试验中，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 将减少新奥尔良42个黑人教堂的非裔美国人的心血管健康差异， 路易斯安那州的博加卢萨。拟议的研究将采用有效性-实施混合设计，以1）。测试 社区卫生工作者（CHW）领导的以教会为基础的多方面实施战略的有效性 在ASCVD高风险的非裔美国人中，在18个月内改善心血管健康，和2）。 评估实施结果（可接受性、适应性、采用性、可行性、忠实性、可接受性、成本- （三）可持续发展战略的同时。RE-AIM框架具有 指导制定和评价多方面的实施战略，其中包括由卫生福利部领导的 关于生活方式改变和药物依从性的健康指导;基于教会的锻炼和减肥 计划;身体活动，血压（BP）和葡萄糖的自我监测;以及提供者教育和 订婚主要有效性结局是≥4的受试者比例的差异 理想或改善的心血管健康指标（CHM），定义为4-5个组成部分的健康饮食评分，或 2个组分较基线增加; 150分钟/周中等强度或75分钟/周剧烈强度 体力活动或两者结合;从不吸烟或戒烟≥6个月;体重指数<25 kg/m2或 体重减轻≥10磅; A1 c <7.0%（或<8.0%伴并发症）;酌情使用他汀类药物治疗;以及 血压<130/80 mmHg或收缩压降低≥10 mmHg。我们的研究有90%的统计能力来检测 使用双侧显著性，18个月时主要有效性结局的绝对差异为15% 0.05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 战略是响应非洲裔美国人社区的需要，我们将确定42个黑人教堂作为研究 合作伙伴和进行健康需求评估;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1，050名非洲裔美国人参加 (25每个教会），年龄≥40岁，有<4个理想的CHM，并随机分配21个教会进行干预 和21控制;我们将实施多方面的干预计划;我们将跟踪参与者， 收集6个月、12个月和18个月的有效性和实施结果数据;我们将评估 在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、传播和扩大经证明行之有效的执行战略。拟定的研究将 提供证据，说明多方面干预措施的有效性、实施情况和可持续性 旨在消除美国高负担人群的心血管健康差异。