Cardiovascular DiseasesCHERISHNCT06065098
Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health
A study testing Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD in people with Cardiovascular Diseases and Hypertension, run by Tulane University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Diseases, Hypertension, Diabetes
- What is being tested?
- Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2023to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Hypertension, Diabetes, Hypercholesterolemia
- Being tested
- Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD
- Keywords
- health inequities, cardiovascular health, community-based interventions, cardiovascular disease prevention
- Medical subject headings
- Cardiovascular Diseases, Hypertension, Diabetes Mellitus, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVDBehavioural
The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia.
| Study group | Role | What they receive |
|---|---|---|
| Community health worker-led implementation strategy: | Experimental | Individual coaching sessions; healthcare navigation; healthcare at community settings; church-based nutrition education and exercise programs; and self-monitoring of BP. Receives: Behavioral: Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD |
| Group-based Education Strategy | Experimental | Group-based education sessions; information on primary care physicians; and instruction on self-monitoring of BP. Receives: Behavioral: Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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.
Measured: Measured at 6, 12, and 18 months
Secondary outcomes (22)
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: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Prior to baseline
Adoption (provider)
Percentage of invited providers attending training sessions. Measured by study administrative data.
Measured: At baseline
Adoption (church)
Percentage of churches adopting the intervention program. Measured by study administrative data.
Measured: 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.
Measured: Baseline
Acceptability
Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is acceptable (satisfactory). Measured by survey.
Measured: Measured at baseline, 6, 12, and 18 months
Penetrance (Participants)
Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measured at 6, 12, and 18 months
Penetrance (Providers)
Percentage of trained providers delivering protocol-based care. Measured by study administrative data.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measured at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start28 Sep 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomization of 46 churches in New Orleans, Louisiana to two arms
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065098
- Sponsor's protocol ID
- 2023-703-SPHTM
- Acronym
- CHERISH
- Status last verified
- May 2026
- First submitted
- 21 Aug 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 37244637He 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.
PubMed 37579311Bundy 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.
PubMed 37244672
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health
- ClinicalTrials.gov ID
- NCT06065098
- Acronym / sponsor ID
- CHERISH / 2023-703-SPHTM
- Conditions
- Cardiovascular Diseases, Hypertension, Diabetes, Hypercholesterolemia
- Keywords
- health inequities, cardiovascular health, community-based interventions, cardiovascular disease prevention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomization of 46 churches in New Orleans, Louisiana to two arms
| Arm | Type | Receives |
|---|---|---|
| Community health worker-led implementation strategy: | Experimental | Behavioral: Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVDIndividual coaching sessions; healthcare navigation; healthcare at community settings; church-based nutrition education and exercise programs; and self-monitoring of BP. |
| Group-based Education Strategy | Experimental | Behavioral: Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVDGroup-based education sessions; information on primary care physicians; and instruction on self-monitoring of BP. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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):
- Willing and able to participate in the intervention
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVDThe recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia. | Behavioural | Community health worker-led implementation strategy:, Group-based Education Strategy |
Primary outcome
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%.
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.
22 secondary outcomes
Difference in change in systolic blood pressure level
Time frame: Measured from baseline to 18 months
Difference in change in diastolic blood pressure level
Time frame: Measured from baseline to 18 months
Difference in change in total cholesterol level
Time frame: Measured from baseline to 18 months
Difference in change in low-density lipoprotein (LDL) cholesterol level
Time frame: Measured from baseline to 18 months
Difference in change in fasting glucose level
Time frame: Measured from baseline to 18 months
Difference in change in hemoglobin A1c level
Time frame: Measured from baseline to 18 months
Difference in change in body weight
Time frame: Measured from baseline to 18 months
Appropriateness
Time frame: Prior to baseline
Adoption (provider)
Time frame: At baseline
Adoption (church)
Time frame: At baseline
Feasibility to participant, community health worker, provider and churches
Time frame: Baseline
Acceptability
Time frame: Measured at baseline, 6, 12, and 18 months
Penetrance (Participants)
Time frame: Measured at baseline, 6, 12, and 18 months
Costs
Time frame: 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
Nutrition Education Session Fidelity (community health worker-led strategy group)
Time frame: 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
Health Care Appointment Fidelity (community health worker-led strategy group)
Time frame: Measured at 6, 12, and 18 months
Penetrance (Providers)
Time frame: Measured at baseline, 6, 12, and 18 months
Penetrance (Educators)
Time frame: Measured at baseline, 6, 12, and 18 months
Sustainability (Churches)
Time frame: Measured at 24 months
Sustainability (Participants)
Time frame: Measured at 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 37244637Maroney 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.
- Background: PubMed 37579311He 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.
- Background: PubMed 37244672Bundy 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD in people with Cardiovascular Diseases and Hypertension, run by Tulane University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in change in estimated atherosclerotic cardiovascular disease (ASCVD) risk score (time frame: Measured from baseline to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06065098, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.