Improving heart health in rural African American communities
Implementation of Heart Matters Evidence-based Program
This study is testing a program called Heart Matters to see if it can improve heart health, especially blood pressure, for African American residents living in rural eastern North Carolina.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 9 sites (Enfield, North Carolina and 8 other locations) |
| Trial ID | NCT06730633 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Heart Matters program in enhancing cardiovascular health outcomes among African American residents in rural eastern North Carolina. Utilizing a non-randomized, propensity-matched-controlled design, the research will involve 210 participants, with 70 matched to a previous study for comparison. The primary focus is on changes in systolic and diastolic blood pressure, with community-based facilitators implementing the program. The study aims to provide insights into the scalability of this evidence-based intervention in underserved populations.
Who should consider this trial
Good fit: Ideal candidates are Black or African American individuals living in rural eastern North Carolina with at least one cardiovascular disease risk factor.
Not a fit: Patients with active or unstable cardiovascular disease or cognitive impairments that limit informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could lead to significant improvements in heart health for African American individuals in rural areas.
How similar studies have performed: Previous studies, such as NCT02707432, have shown feasibility and efficacy for similar interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Identify as Black or African American * Reside in rural, eastern North Carolina * Self-report at least one cardiovascular disease risk factor, such as pre-diabetes, pre-hypertension or stage one hypertension, obesity, or family history of early heart disease Exclusion Criteria: * Evidence of active or unstable cardiovascular disease * Cognitive impairment that limits informed consent
Where this trial is running
Enfield, North Carolina and 8 other locations
- A Better Chance, A Better Community — Enfield, North Carolina, United States (Recruiting)
- The Mercer Foundation, Inc. — Nashville, North Carolina, United States (Active_not_recruiting)
- Marks Chapel Baptist Church — Rocky Mount, North Carolina, United States (Active_not_recruiting)
- Thorne's Chapel Missionary Baptist Church — Rocky Mount, North Carolina, United States (Active_not_recruiting)
- Truth Tabernacle Ministries — Rocky Mount, North Carolina, United States (Active_not_recruiting)
- Girls Making the Grade — Rocky Mount, North Carolina, United States (Recruiting)
- Carolina Hierarchy of Needs — Spring Hope, North Carolina, United States (Active_not_recruiting)
- St. James United Holy Church — Stantonsburg, North Carolina, United States (Recruiting)
- Warren County Health Department — Warrenton, North Carolina, United States (Active_not_recruiting)
Study contacts
- Principal investigator: Gaurav Dave, MBBS, DrPH — University of North Carolina, Chapel Hill
- Study coordinator: Gaurav Dave, MBBS, DrPH
- Email: gaurav_dave@med.unc.edu
- Phone: (919) 843-8271
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.