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.

项目摘要/摘要 路易斯安那州的居民，尤其是非裔美国人，对动脉粥样硬化的燃烧量不成比例 心血管疾病（ASCVD）。在拟议的群集随机试验中，我们将测试是否有多方面 实施2019年ACC/AHA心血管疾病主要预防指南的策略 将减少来自新奥尔良42个黑人教堂的非裔美国人的心血管健康差异， 路易斯安那州博加鲁萨。拟议的研究将利用1）使用有效性实施混合设计。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 为了改善ASCVD高风险的非洲裔美国人的18个月内的心血管健康和2）。 评估实施结果（可接受性，适应性，采用，可行性，忠诚度，外观，成本 - 简单地策略的有效性和可持续性）。 Re-Aim框架有 指导了多方面实施策略的发展和评估，其中包括CHW领导 健康指导生活方式的改变和药物依从性；基于教会的运动和减肥 程序；体育锻炼，血压（BP）和葡萄糖的自我监控；以及提供商的教育和 订婚。主要有效性结果是≥4的参与者比例的差异 理想或改善的心血管健康指标（CHM），定义为健康饮食评分为4-5个成分或 基线增加了2个成分； 150分钟/周中或75分钟/周/周剧烈强度 体育锻炼或组合；从不吸烟或安静≥6个月前；体重指数<25 kg/m2或 体重减轻≥10磅； A1C <7.0％（或并发症<8.0％）；适当使用他汀类药物治疗；和 BP <130/80 mmHg或收缩BP降低≥10mmHg。我们的研究具有90％的统计能力来检测 在18个月时，主要有效性结果的绝对差异为15％，使用2面显着性 水平为0.05。在计划阶段，我们将与利益相关者合作，以确保多方面的实施 战略对非裔美国人社区的需求有回应；我们将确定42个黑人教堂是研究 合作伙伴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1,050名非裔美国人参与者 （每教堂25岁）年龄≥40岁的人，他们的理想CHM <4个，并随机分配了21个教堂 和21控制；我们将实施多方面的干预计划；我们将跟进参与者和 收集有关6、12和18个月的有效性和实施结果的数据；我们将评估 干预后6个月的干预研究的可持续性；我们将执行意向性治疗 分析并扩展并扩大证明有效的实施策略。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 旨在消除美国高负荷人群中的心血管健康差异。