Reducing coronary heart disease disparities in African Americans
ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region
NA · University Hospitals Cleveland Medical Center · NCT05918380
This study is testing a program that uses community health workers to help Black and African American people in Detroit and Cleveland manage their heart disease risk factors and improve their overall health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospitals Cleveland Medical Center (other) |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05918380 on ClinicalTrials.gov |
What this trial studies
This project aims to address cardiometabolic health disparities and lifespan inequality among Black and African American individuals in Detroit and Cleveland. It utilizes Community Health Workers (CHWs) to implement an evidence-based intervention program called PAL2, which focuses on risk factor control for coronary heart disease. Participants will be screened for specific health risk factors and will receive tailored support to improve their health outcomes. The program also includes structured training for CHWs to enhance their effectiveness in delivering care.
Who should consider this trial
Good fit: Ideal candidates for this project are Black or African American individuals aged 40 to 75 with specific health risk factors related to coronary heart disease.
Not a fit: Patients with established cardiovascular disease or those with severe hypertension or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this initiative could significantly reduce the incidence of coronary heart disease and improve overall health outcomes for African American patients.
How similar studies have performed: Other studies focusing on health disparities and community health worker interventions have shown promise, suggesting that this approach could be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 40 to 75 years of age 2. Self-identified as Black or African American 3. Residence in the Cleveland Metro Area 4. Must have at least two of the following risk factors identified at a UH health fair screenings, with one risk factor being with SBP, A1c, or LDL: 1. BMI≥30 mg/dL 2. History of smoking 3. Elevated blood pressure defined as SBP\>140 or DBP\>80 mmHg 4. HbA1c≥5.7% 5. LDL≥130 5. Able to complete a coronary artery calcium score test (CAC) 6. Willing and able to consent 7. Willing to have a UH provider and UH care 8. Currently insured for standard of care procedures Exclusion Criteria: 1. Established documented cardiovascular disease (coronary artery disease, peripheral artery disease, myocardial infarction, stroke). 2. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg 3. Lung disease requiring supplemental oxygen therapy 4. Individuals receiving treatment for cancer related disease 5. Pregnant or nursing mothers
Where this trial is running
Cleveland, Ohio
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
Study contacts
- Principal investigator: Sanjay Rajagopalan, MD — University Hospitals Cleveland Medical Center
- Study coordinator: Sanjay Rajagopalan, MD
- Email: Sanjay.Rajagopalan@uhhospitals.org
- Phone: 216-844-5191
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Heart Disease, Health Disparities, African American, Prevention