Cardiovascular Diseases, Diabetes, Hypercholesterolemia, Hypertension
Conditions
Keywords
health inequities, cardiovascular health, community-based interventions, cardiovascular disease prevention
Brief 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.
Detailed 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 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.
Interventions
BEHAVIORALEvidence-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.
Sponsors
Tulane University
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Cluster-randomization of 46 churches in New Orleans, Louisiana to two arms
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in change in estimated atherosclerotic cardiovascular disease (ASCVD) risk score | 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%. |
| Fidelity summary score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in change in systolic blood pressure level | Measured from baseline to 18 months | The change in systolic blood pressure level from baseline to 18 months between the two arms. |
| Difference in change in diastolic blood pressure level | Measured from baseline to 18 months | The change in diastolic blood pressure level from baseline to 18 months between the two arms. |
| Difference in change in total cholesterol level | Measured from baseline to 18 months | The change in total cholesterol level from baseline to 18 months between the two arms. |
| Difference in change in low-density lipoprotein (LDL) cholesterol level | Measured from baseline to 18 months | The difference in the change in LDL cholesterol level between the two arms. |
| Difference in change in fasting glucose level | Measured from baseline to 18 months | The change in fasting glucose level from baseline to 18 months between the two arms. |
| Difference in change in hemoglobin A1c level | Measured from baseline to 18 months | The change in hemoglobin A1c level from baseline to 18 months between the two arms |
| Difference in change in body weight | Measured from baseline to 18 months | The change in body weight from baseline to 18 months between the two arms. |
| Appropriateness | Prior to baseline | 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. |
| Adoption (provider) | At baseline | Percentage of invited providers attending training sessions. Measured by study administrative data. |
| Adoption (church) | At baseline | Percentage of churches adopting the intervention program. Measured by study administrative data. |
| Feasibility to participant, community health worker, provider and churches | Baseline | 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. |
| Acceptability | Measured at baseline, 6, 12, and 18 months | Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is acceptable (satisfactory). Measured by survey. |
| Penetrance (Participants) | Measured at baseline, 6, 12, and 18 months | Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data. |
| Costs | Baseline, 6, 12, and 18 months | Implementation costs related to intervention and healthcare but not to study data collection. Measured by study administrative data. |
| Health Coaching Session Fidelity (community health worker-led strategy group) | Measured at 6, 12, and 18 months | Percentage of health coaching sessions conducted. Measured by study administrative data. |
| Nutrition Education Session Fidelity (community health worker-led strategy group) | Measured at 6, 12, and 18 months | Percentage of nutrition education sessions organized. Measured by study administrative data. |
| Exercise Session Fidelity (community health worker-led strategy group) | Measured at 6, 12, and 18 months | Percentage of exercise sessions organized. Measured by study administrative data. |
| Health Care Appointment Fidelity (community health worker-led strategy group) | Measured at 6, 12, and 18 months | Percentage of health care visit appointments made. Measured by study administrative data. |
| Penetrance (Providers) | Measured at baseline, 6, 12, and 18 months | Percentage of trained providers delivering protocol-based care. Measured by study administrative data. |
| Penetrance (Educators) | Measured at baseline, 6, 12, and 18 months | Percentage of trained CHWs or providers and health educators delivering health coaching. Measured by study administrative data. |
| Sustainability (Churches) | Measured at 24 months | Percentage of churches continuing the intervention program and individual components. Measured by 6-month post-intervention survey. |
| Sustainability (Participants) | Measured at 24 months | Percentage of participants maintaining ideal cardiovascular health metrics, healthy lifestyle components, and adherence to medications. Measured by 6-month post-intervention survey and examination. |
Countries
United States
Outcome results
None listed