Clinical trial NCT06065098: Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health
Official title: Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Hypertension
Diabetes
Hypercholesterolemia
Keywords: health inequities
cardiovascular health
community-based interventions
cardiovascular disease prevention
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-10-03
Enrollment: 1050
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomization of 42 churches in New Orleans, Louisiana to two arms
Primary purpose: 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in change in estimated atherosclerotic cardiovascular disease (ASCVD) risk score
timeFrame: Measured from baseline to 18 months
measure: Fidelity summary score
timeFrame: Measured at 6, 12, and 18 months
Secondary outcomes:
measure: Difference in change in systolic blood pressure level
timeFrame: Measured from baseline to 18 months
measure: Difference in change in diastolic blood pressure level
timeFrame: Measured from baseline to 18 months
measure: Difference in change in total cholesterol level
timeFrame: Measured from baseline to 18 months
measure: Difference in change in low-density lipoprotein (LDL) cholesterol level
timeFrame: Measured from baseline to 18 months
measure: Difference in change in fasting glucose level
timeFrame: Measured from baseline to 18 months
measure: Difference in change in hemoglobin A1c level
timeFrame: Measured from baseline to 18 months
measure: Difference in change in body weight
timeFrame: Measured from baseline to 18 months
measure: Appropriateness
timeFrame: Prior to baseline
measure: Adoption (provider)
timeFrame: At baseline
measure: Adoption (church)
timeFrame: At baseline
measure: Feasibility to participant, community health worker, provider and churches
timeFrame: Baseline
measure: Acceptability
timeFrame: Measured at baseline, 6, 12, and 18 months
measure: Penetrance (Participants)
timeFrame: Measured at baseline, 6, 12, and 18 months
measure: Costs
timeFrame: Baseline, 6, 12, and 18 months
measure: Health Coaching Session Fidelity (community health worker-led strategy group)
timeFrame: Measured at 6, 12, and 18 months
measure: Nutrition Education Session Fidelity (community health worker-led strategy group)
timeFrame: Measured at 6, 12, and 18 months
measure: Exercise Session Fidelity (community health worker-led strategy group)
timeFrame: Measured at 6, 12, and 18 months
measure: Health Care Appointment Fidelity (community health worker-led strategy group)
timeFrame: Measured at 6, 12, and 18 months
measure: Penetrance (Providers)
timeFrame: Measured at baseline, 6, 12, and 18 months
measure: Penetrance (Educators)
timeFrame: Measured at baseline, 6, 12, and 18 months
measure: Sustainability (Churches)
timeFrame: Measured at 24 months
measure: Sustainability (Participants)
timeFrame: Measured at 24 months
Other outcomes:
measure: Difference in proportion of those receiving statin treatment who are eligible
timeFrame: Measured from baseline to 18 months
measure: Difference in proportion of those who cease smoking of those who are current smokers at baseline
timeFrame: Measured from baseline to 18 months
measure: Difference in medication adherence
timeFrame: Measured from baseline to 18 months
measure: Difference in quality of life (QoL)
timeFrame: Measured from baseline to 18 months
Locations:
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
Study officials:
References:
citation: Maroney K, Laurent J, Alvarado F, Gabor A, Bell C, Ferdinand K, He J, Mills KT. Systematic review and meta-analysis of church-based interventions to improve cardiovascular disease risk factors. Am J Med Sci. 2023 Sep;366(3):199-208. doi: 10.1016/j.amjms.2023.05.010. Epub 2023 May 25.
citation: He J, Bundy JD, Geng S, Tian L, He H, Li X, Ferdinand KC, Anderson AH, Dorans KS, Vasan RS, Mills KT, Chen J. Social, Behavioral, and Metabolic Risk Factors and Racial Disparities in Cardiovascular Disease Mortality in U.S. Adults : An Observational Study. Ann Intern Med. 2023 Sep;176(9):1200-1208. doi: 10.7326/M23-0507. Epub 2023 Aug 15.
citation: Bundy JD, Mills KT, He H, LaVeist TA, Ferdinand KC, Chen J, He J. Social determinants of health and premature death among adults in the USA from 1999 to 2018: a national cohort study. Lancet Public Health. 2023 Jun;8(6):e422-e431. doi: 10.1016/S2468-2667(23)00081-6.