- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06065098
Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health (CHERISH)
January 2, 2024 updated by: Tulane University
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.
Study Overview
Status
Recruiting
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 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.
Study Type
Interventional
Enrollment (Estimated)
1050
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katherine T Mills, PhD
- Phone Number: 504-988-4749
- Email: kmills4@tulane.edu
Study Contact Backup
- Name: Joide Laurent, MPH
- Phone Number: 504-988-5432
- Email: jlaurent@tulane.edu
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Recruiting
- Tulane University
-
Contact:
- Katherine T Mills, PhD
- Phone Number: 504-988-4749
- Email: kmills4@tulane.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Community health worker-led implementation strategy:
Individual coaching sessions; healthcare navigation; healthcare at community settings; church-based nutrition education and exercise programs; and self-monitoring of BP.
|
The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia.
|
Experimental: Group-based Education Strategy
Group-based education sessions; information on primary care physicians; and instruction on self-monitoring of BP.
|
The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in change in estimated atherosclerotic cardiovascular disease (ASCVD) risk score
Time Frame: 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%.
|
Measured from baseline to 18 months
|
Fidelity summary score
Time Frame: 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.
|
Measured at 6, 12, and 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in change in systolic blood pressure level
Time Frame: Measured from baseline to 18 months
|
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
Time Frame: Measured from baseline to 18 months
|
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
Time Frame: Measured from baseline to 18 months
|
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
Time Frame: Measured from baseline to 18 months
|
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
Time Frame: Measured from baseline to 18 months
|
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
Time Frame: Measured from baseline to 18 months
|
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
Time Frame: Measured from baseline to 18 months
|
The change in body weight from baseline to 18 months between the two arms.
|
Measured from baseline to 18 months
|
Appropriateness
Time Frame: 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.
|
Prior to baseline
|
Adoption (provider)
Time Frame: At baseline
|
Percentage of invited providers attending training sessions.
Measured by study administrative data.
|
At baseline
|
Adoption (church)
Time Frame: At baseline
|
Percentage of churches adopting the intervention program.
Measured by study administrative data.
|
At baseline
|
Feasibility to participant, community health worker, provider and churches
Time Frame: 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.
|
Baseline
|
Acceptability
Time Frame: 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.
|
Measured at baseline, 6, 12, and 18 months
|
Penetrance (Participants)
Time Frame: Measured at baseline, 6, 12, and 18 months
|
Percentage of enrolled participants receiving assigned intervention.
Measured by study administrative data.
|
Measured at baseline, 6, 12, and 18 months
|
Costs
Time Frame: Baseline, 6, 12, and 18 months
|
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)
Time Frame: Measured at 6, 12, and 18 months
|
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)
Time Frame: Measured at 6, 12, and 18 months
|
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)
Time Frame: Measured at 6, 12, and 18 months
|
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)
Time Frame: Measured at 6, 12, and 18 months
|
Percentage of health care visit appointments made.
Measured by study administrative data.
|
Measured at 6, 12, and 18 months
|
Penetrance (Providers)
Time Frame: Measured at baseline, 6, 12, and 18 months
|
Percentage of trained providers delivering protocol-based care.
Measured by study administrative data.
|
Measured at baseline, 6, 12, and 18 months
|
Penetrance (Educators)
Time Frame: 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.
|
Measured at baseline, 6, 12, and 18 months
|
Sustainability (Churches)
Time Frame: Measured at 24 months
|
Percentage of churches continuing the intervention program and individual components.
Measured by 6-month post-intervention survey.
|
Measured at 24 months
|
Sustainability (Participants)
Time Frame: 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.
|
Measured at 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in proportion of those receiving statin treatment who are eligible
Time Frame: Measured from baseline to 18 months
|
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
|
Difference in proportion of those who cease smoking of those who are current smokers at baseline
Time Frame: Measured from baseline to 18 months
|
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
|
Difference in medication adherence
Time Frame: Measured from baseline to 18 months
|
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
|
Difference in quality of life (QoL)
Time Frame: Measured from baseline to 18 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2023
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
February 28, 2028
Study Registration Dates
First Submitted
August 21, 2023
First Submitted That Met QC Criteria
September 26, 2023
First Posted (Actual)
October 3, 2023
Study Record Updates
Last Update Posted (Actual)
January 5, 2024
Last Update Submitted That Met QC Criteria
January 2, 2024
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-703-SPHTM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Our study data sharing plan will comply with all NIH policies for data sharing.
Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner.
The study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC).
The datasets will be submitted to the NHLBI no later than three years after the end of the final participant follow-up or two years after the main paper of the trial has been published, whichever comes first.
The NHLBI will review the submitted data prior to release.
These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure."
In addition, we will offer, through our publicly accessible website, opportunities for outside investigators to collaborate with us using complete study data.
IPD Sharing Time Frame
No later than three years after the end of the final participant follow-up or two years after the main paper of the trial has been published, whichever comes first
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Medical College of WisconsinRecruitingCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
-
Nanjing Medical UniversityRecruiting
-
Centre Hospitalier Universitaire de la RéunionRecruitingCardiovascular DiseaseFrance
-
National Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular DiseaseUnited States
-
National Heart, Lung, and Blood Institute (NHLBI)RecruitingCardiovascular DiseaseUnited States
Clinical Trials on Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD
-
Tulane UniversityNational Institute on Minority Health and Health Disparities (NIMHD); National...RecruitingHypertensionUnited States