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

Phase

N/A

Condition

Stress

Diabetic Neuropathy

Diabetic Macular Edema

Treatment

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

Clinical Study ID

NCT06065098

2023-703-SPHTM

Ages > 40
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Men or women aged ≥40 years
Community members associated with the participating churches (church members andtheir 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 <75minutes/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

Exclusion Criteria:

No prior hospitalization in the last 3 months for chronic heart failure or heartattack.
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.

Study Design

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

September 28, 2023

August 31, 2027

Study Description

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 90% statistical power to detect a difference in 10-year ASCVD risk of 2.5% over 18 months using a 2-sided significance level of 0.05. We will recruit 1,050 participants (25 per church) aged ≥40 years who have <3 ideal cardiovascular health matrices 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 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.

Connect with a study center

Tulane University
New Orleans, Louisiana 70112
United States
Active - Recruiting

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