Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 812
- 试验地点
- 2
- 主要终点
- Fidelity summary score
研究概览
简要总结
Cardiovascular disease (CVD) is the leading cause of death in the US general population. Although CVD mortality rates declined for both Black and White populations during the past two decades, they are still higher in Black adults than White adults. There are also persistent disparities in CVD risk factors with higher prevalence of obesity, hypertension, and diabetes in Black compared to White populations. In addition, CVD and risk factors are more prevalent in the residents of Louisiana compared to the US general population. The Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health (CHERISH) study will use a church-based community health worker (CHW)-led multifaceted intervention to address racial inequities in CVD risk factors in predominantly Black communities in New Orleans, Louisiana. The primary aim of the CHERISH study is to compare the impact of two implementation strategies - a CHW-led multifaceted strategy and a group-based education strategy - for delivering interventions recommended by the 2019 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on the Primary Prevention of Cardiovascular Disease on implementation and clinical effectiveness outcomes in predominantly Black church community members over 18 months.
详细描述
Louisiana residents, especially African Americans, bear a disproportionately high burden of CVD. In the CHERISH cluster randomized trial, we will compare the impact of two implementation strategies - a CHW-led multifaceted strategy and a group-based education strategy - for delivering interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease on implementation and clinical effectiveness outcomes in Black community members over 18 months. The CHERISH study utilizes an effectiveness-implementation hybrid design to: (1). test the effectiveness of a CHW-led church-based multifaceted implementation strategy for reducing estimated CVD risk over 18 months among African Americans at high risk for CVD, and (2). assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, penetrance, cost-effectiveness, and sustainability) simultaneously. The Exploration, Preparation, Implementation, Sustainment (EPIS) framework has guided the development and evaluation of the multifaceted implementation strategy, which includes CHW-led health coaching on lifestyle changes and medication adherence; healthcare delivery in community; church-based exercise and weight loss programs; self-monitoring of blood pressure (BP); and provider education and engagement. The CHW-led church-based intervention will provide strong social support and tackle multiple social determinants of CVD disparities. The primary effectiveness outcome is change in the estimated 10-year risk for atherosclerotic CVD (ASCVD) using the ACC/AHA Pooled Cohort Equations. The primary implementation outcome is a fidelity summary score for key implementation strategy components during the 18-month intervention. Our study has 96% statistical power to detect a slope difference of 0.83% in 10-year ASCVD risk over 18 months using a 2-sided significance level of 0.05. We will recruit 806 participants (17.5 per church) aged ≥40 years who have <3 ideal cardiovascular health matrices and randomly assign 23 churches to intervention and 23 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 at 6 months post-intervention; 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 CVD disparities in predominantly African American communities in the US.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinical research coordinators and laboratory technicians who assess health-related outcomes will be blinded to intervention assignment. Study physicians who review serious adverse events and unanticipated problems will also be blinded to intervention assignment.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged ≥40 years
- •Community members associated with the participating churches (church members and their families and friends)
- •Individuals with three or more CVD risk factors (out of seven):
- •Current smoker
- •Overweight or obese (BMI ≥25 kg/m2)
- •Insufficient physical activity (<150 minutes/week moderate intensity or <75 minutes/week vigorous intensity)
- •Healthy diet score of <4 components
- •Total cholesterol ≥200 mg/dL
- •Blood pressure ≥130/80 mmHg
- •Fasting plasma glucose ≥100 mg/dL
- •Willing and able to participate in the intervention
排除标准
- •No prior hospitalization in the last 3 months for chronic heart failure or heart attack.
- •No current diagnosis of cancer requiring chemotherapy or radiation therapy
- •No stage-5 chronic kidney disease requiring chronic dialysis, or transplant.
- •Not pregnant or planning to become pregnant in the next 18 months.
- •No plans to move out of the New Orleans metropolitan area during the next year.
研究组 & 干预措施
Community health worker-led implementation strategy:
Individual coaching sessions; healthcare navigation; healthcare at community settings; church-based nutrition education and exercise programs; and self-monitoring of BP.
干预措施: Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD (Behavioral)
Group-based Education Strategy
Group-based education sessions; information on primary care physicians; and instruction on self-monitoring of BP.
干预措施: Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD (Behavioral)
结局指标
主要结局
Fidelity summary score
时间窗: Measured at 6, 12, and 18 months
The fidelity summary score is composed of the following key implementation strategy components: proportion of assigned health education sessions attended in all participants, proportion of assigned discussion sessions attended in all participants, proportion of recommended minutes of physical activity completed in all participants, proportion of days per week that fruits/vegetables are eaten as recommended in all participants, proportion of recommended home BP monitoring completed in patients with hypertension, proportion of required provider visits attended in all patients, and proportion of antihypertensive, antidiabetic, and statin medications taken in patients with hypertension or diabetes, or those who are eligible for statin treatment, respectively.
Difference in change in estimated atherosclerotic cardiovascular disease (ASCVD) risk score
时间窗: Measured from baseline to 18 months
The ACC/AHA ASCVD risk score will be calculated using the pooled population cohort equation based on age (years), total cholesterol (mg/dL), high-density lipoprotein (HDL)-cholesterol (mg/dL), antihypertensive medication use, systolic BP (mmHg), current smoking status, and diabetes status. The risk score ranges from 0% to 100%.
次要结局
- Difference in change in total cholesterol level(Measured from baseline to 18 months)
- Difference in change in fasting glucose level(Measured from baseline to 18 months)
- Adoption (provider)(At baseline)
- Adoption (church)(At baseline)
- Feasibility to participant, community health worker, provider and churches(Baseline)
- Acceptability(Measured at baseline, 6, 12, and 18 months)
- Penetrance (Participants)(Measured at baseline, 6, 12, and 18 months)
- Difference in change in low-density lipoprotein (LDL) cholesterol level(Measured from baseline to 18 months)
- Difference in change in hemoglobin A1c level(Measured from baseline to 18 months)
- Exercise Session Fidelity (community health worker-led strategy group)(Measured at 6, 12, and 18 months)
- Penetrance (Providers)(Measured at baseline, 6, 12, and 18 months)
- Difference in change in body weight(Measured from baseline to 18 months)
- Appropriateness(Prior to baseline)
- Costs(Baseline, 6, 12, and 18 months)
- Health Coaching Session Fidelity (community health worker-led strategy group)(Measured at 6, 12, and 18 months)
- Difference in change in systolic blood pressure level(Measured from baseline to 18 months)
- Difference in change in diastolic blood pressure level(Measured from baseline to 18 months)
- Nutrition Education Session Fidelity (community health worker-led strategy group)(Measured at 6, 12, and 18 months)
- Health Care Appointment Fidelity (community health worker-led strategy group)(Measured at 6, 12, and 18 months)
- Penetrance (Educators)(Measured at baseline, 6, 12, and 18 months)
- Sustainability (Churches)(Measured at 24 months)
- Sustainability (Participants)(Measured at 24 months)