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

Study Overview
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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 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 Black community members over 18 months.

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 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 African American participants (25 per church) aged ≥40 years who have <4 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 African American populations in the US.

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

Conditions
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Cardiovascular Diseases, Hypertension, Diabetes, Hypercholesterolemia

Intervention / Treatment
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* Behavioral: Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Black or African American men or women aged ≥40 years Community members associated with the participating churches (church members and their families and friends) Individuals with four 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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-randomization of 42 churches in New Orleans, Louisiana to two arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community health worker-led implementation strategy:<br>Individual coaching sessions; healthcare navigation; healthcare at community settings; church-based nutrition education and exercise programs; and self-monitoring of BP. | Behavioral: Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD<br>* The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia.<br>|
| Experimental: Group-based Education Strategy<br>Group-based education sessions; information on primary care physicians; and instruction on self-monitoring of BP. | Behavioral: Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD<br>* The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in change in estimated atherosclerotic cardiovascular disease (ASCVD) risk score | 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%. | Measured from baseline to 18 months | 
| Fidelity summary score | 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. | Measured at 6, 12, and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in change in systolic blood pressure level | The change in systolic blood pressure level from baseline to 18 months between the two arms. | Measured from baseline to 18 months | 
| Difference in change in diastolic blood pressure level | The change in diastolic blood pressure level from baseline to 18 months between the two arms. | Measured from baseline to 18 months | 
| Difference in change in total cholesterol level | The change in total cholesterol level from baseline to 18 months between the two arms. | Measured from baseline to 18 months | 
| Difference in change in low-density lipoprotein (LDL) cholesterol level | The difference in the change in LDL cholesterol level between the two arms. | Measured from baseline to 18 months | 
| Difference in change in fasting glucose level | The change in fasting glucose level from baseline to 18 months between the two arms. | Measured from baseline to 18 months | 
| Difference in change in hemoglobin A1c level | The change in hemoglobin A1c level from baseline to 18 months between the two arms | Measured from baseline to 18 months | 
| Difference in change in body weight | The change in body weight from baseline to 18 months between the two arms. | Measured from baseline to 18 months | 
| Appropriateness | Percentage of participants, community health workers, providers, and church administrators who reply that the intervention is appropriate (good perceived fit). The outcome will be measured by survey question. | Prior to baseline | 
| Adoption (provider) | Percentage of invited providers attending training sessions. Measured by study administrative data. | At baseline | 
| Adoption (church) | Percentage of churches adopting the intervention program. Measured by study administrative data. | At baseline | 
| Feasibility to participant, community health worker, provider and churches | Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is feasible (actual fit, suitability). Measured by survey and study administrative data. | Baseline | 
| Acceptability | Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is acceptable (satisfactory). Measured by survey. | Measured at baseline, 6, 12, and 18 months | 
| Penetrance (Participants) | Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data. | Measured at baseline, 6, 12, and 18 months | 
| Costs | Implementation costs related to intervention and healthcare but not to study data collection. Measured by study administrative data. | Baseline, 6, 12, and 18 months | 
| Health Coaching Session Fidelity (community health worker-led strategy group) | Percentage of health coaching sessions conducted. Measured by study administrative data. | Measured at 6, 12, and 18 months | 
| Nutrition Education Session Fidelity (community health worker-led strategy group) | Percentage of nutrition education sessions organized. Measured by study administrative data. | Measured at 6, 12, and 18 months | 
| Exercise Session Fidelity (community health worker-led strategy group) | Percentage of exercise sessions organized. Measured by study administrative data. | Measured at 6, 12, and 18 months | 
| Health Care Appointment Fidelity (community health worker-led strategy group) | Percentage of health care visit appointments made. Measured by study administrative data. | Measured at 6, 12, and 18 months | 
| Penetrance (Providers) | Percentage of trained providers delivering protocol-based care. Measured by study administrative data. | Measured at baseline, 6, 12, and 18 months | 
| Penetrance (Educators) | Percentage of trained CHWs or providers and health educators delivering health coaching. Measured by study administrative data. | Measured at baseline, 6, 12, and 18 months | 
| Sustainability (Churches) | Percentage of churches continuing the intervention program and individual components. Measured by 6-month post-intervention survey. | Measured at 24 months | 
| Sustainability (Participants) | Percentage of participants maintaining ideal cardiovascular health metrics, healthy lifestyle components, and adherence to medications. Measured by 6-month post-intervention survey and examination. | Measured at 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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health inequities, cardiovascular health, community-based interventions, cardiovascular disease prevention