Improving blood pressure control through community partnerships and remote monitoring
PRESSURE CHECK: Find Your Path to Better Health
This study is testing if adding support from community health workers to a remote blood pressure management program can help people control their blood pressure better than just using the program alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (New Haven, Connecticut and 3 other locations) |
| Trial ID | NCT06122246 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance blood pressure management by comparing two innovative approaches: a remote blood pressure management program (RBPM) alone and an RBPM program supplemented with support from community health workers (CHWs). Participants will be enrolled from various community-based organizations across four cities, where they will receive either standard care or one of the two intervention strategies. The effectiveness of these approaches will be evaluated based on their ability to control blood pressure and address social determinants of health. Participants will use home blood pressure monitors and engage in telehealth visits with healthcare professionals to optimize their treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with elevated blood pressure, defined as an average resting BP of 135/85 mmHg or higher.
Not a fit: Patients who are pregnant, have end-stage renal disease on dialysis, or are receiving active chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood pressure control and better health outcomes for patients with hypertension.
How similar studies have performed: Other studies have shown promise in using remote monitoring and community health worker support for managing chronic conditions, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elevated BP, defined as an average resting BP of \>=135/85 mmHg based on 3 consecutive blood pressure readings Exclusion Criteria: * People who are pregnant or who plan to become pregnant in the next 6 months at study entry * Those that have end stage renal disease on dialysis * People receiving active chemotherapy
Where this trial is running
New Haven, Connecticut and 3 other locations
- Yale — New Haven, Connecticut, United States (Recruiting)
- Massachusetts General Brigham Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Houston Methodist — Houston, Texas, United States (Not_yet_recruiting)
- Sentara Health — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Erica Spatz, MD — Yale University
- Study coordinator: Bonnie Garmisa, MAT
- Email: bonnie.garmisa@yale.edu
- Phone: (203) 640-2684
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.