Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
Part of paid clinical trials in New Orleans, Louisiana.
- Sponsor
- Tulane University
- Study ID
- NCT06133322
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline — BEHAVIORALThe recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension
Study Details
The burden of hypertension and related cardiovascular diseases, stroke, and end-stage kidney disease is disproportionately high in Black populations, especially in the South. The Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial aims to test the effectiveness, implementation, and sustainability of a community health worker (CHW)-led multifaceted intervention compared to enhanced usual care for hypertension control in Black communities. In the BLESSED trial, the investigators plan to recruit 1,176 adults with hypertension (approximately 28 per church) from 42 predominantly Black churches in the Greater New Orleans area. The multifaceted intervention will last for 18 months, followed by a post-intervention follow-up visit at 24 months. The BLESSED trial aims to generate evidence regarding the effectiveness, implementation, and sustainability of this CHW-led church-based multifaceted intervention in eliminating hypertension disparities in the United States (US) general population.
Key Dates
- Start date
- Nov 1, 2023
- Status verified
- May 2024
- Primary completion
- Aug 31, 2026
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 1,176 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Community health worker-led implementation strategyCHW-led church-based multifaceted implementation strategy: CHWs will conduct individualized health coaching and healthcare navigation, organize church-based health promotion programs (e.g., nutrition education and exercise sessions), and train and assist the study participants in self-monitoring of BP. Nurse practitioners will see study participants at church settings, and community pharmacies will deliver antihypertensive medications to patients' homes.
- Experimental: Group-based Education StrategyThe investigator team will work with church leadership and wellness coordinators to organize group-based education sessions. Health education will be delivered by local primary care providers, dieticians, and health educators. Contact information for primary care providers and information on self-monitoring of BP will also be given at group sessions.
Primary Outcome Measure
Difference in mean change of systolic blood pressure [ Time Frame: Measured from baseline to 18 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tulane University | New Orleans | Louisiana | 70112 |
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