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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
806
The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia.
Tulane University
New Orleans, Louisiana, United States
RECRUITINGDifference 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%.
Time frame: 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.
Time frame: Measured at 6, 12, and 18 months
Difference in change in systolic blood pressure level
The change in systolic blood pressure level from baseline to 18 months between the two arms.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Prior to baseline
Adoption (provider)
Percentage of invited providers attending training sessions. Measured by study administrative data.
Time frame: At baseline
Adoption (church)
Percentage of churches adopting the intervention program. Measured by study administrative data.
Time frame: 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.
Time frame: Baseline
Acceptability
Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is acceptable (satisfactory). Measured by survey.
Time frame: Measured at baseline, 6, 12, and 18 months
Penetrance (Participants)
Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at 6, 12, and 18 months
Penetrance (Providers)
Percentage of trained providers delivering protocol-based care. Measured by study administrative data.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Measured at 24 months
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