Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

806 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2027-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiovascular Diseases Hypertension Diabetes Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster-randomization of 46 churches in New Orleans, Louisiana to two arms

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD

Intervention Type BEHAVIORAL

The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia.

Group-based Education Strategy

Group-based education sessions; information on primary care physicians; and instruction on self-monitoring of BP.

Group Type EXPERIMENTAL

Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD

Intervention Type BEHAVIORAL

The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia.

Interventions

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Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD

The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No