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

Hypertension Clinical Trial

— CHERISH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06065098
• Other study ID #: 2023-703-SPHTM
• Status: Recruiting
• Phase: N/A
• Start date: November 18, 2023
• Est. completion date: February 28, 2028

Study information

• Verified date: August 2023
• Source: Tulane University
• Contact: Joide Laurent, MPH
• Phone: 504-988-5432
• Email: jlaurent[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: February 28, 2028
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Hypercholesterolemia
• Hypertension

Intervention

Behavioral:
• Evidence-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.

Locations

Country	Name	City	State
United States	Tulane University	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Tulane University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in proportion of those receiving statin treatment who are eligible	Percentage of those receiving statin treatment who are eligible between the two arms over 18 months. Measured by survey data.	Measured from baseline to 18 months
Other	Difference in proportion of those who cease smoking of those who are current smokers at baseline	Percentage of those who cease smoking of those who are current smokers at baseline between the two arms over 18 months. Measured by survey data.	Measured from baseline to 18 months
Other	Difference in medication adherence	Percentage of self-reported medication adherence over 18 months. Self-reported medication adherence will be assessed using an medication adherence questionnaire.	Measured from baseline to 18 months
Other	Difference in quality of life (QoL)	The difference in QoL between the two arms over 18 months. QoL will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	Measured from baseline to 18 months
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adoption (provider)	Percentage of invited providers attending training sessions. Measured by study administrative data.	At baseline
Secondary	Adoption (church)	Percentage of churches adopting the intervention program. Measured by study administrative data.	At baseline
Secondary	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
Secondary	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
Secondary	Penetrance (Participants)	Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.	Measured at baseline, 6, 12, and 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Penetrance (Providers)	Percentage of trained providers delivering protocol-based care. Measured by study administrative data.	Measured at baseline, 6, 12, and 18 months
Secondary	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
Secondary	Sustainability (Churches)	Percentage of churches continuing the intervention program and individual components. Measured by 6-month post-intervention survey.	Measured at 24 months
Secondary	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