Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
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 Black adults with hypertension (approximately 28 per church) from 42 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.
Conditions:
🦠 Hypertension
🗓️ Study Start (Actual) 1 November 2023
🗓️ Primary Completion (Estimated) 31 August 2026
✅ Study Completion (Estimated) 30 June 2027
👥 Enrollment (Estimated) 1176
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New Orleans, Louisiana, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Black or African American men or women aged ≥18 years
    • 2. Community members associated with the participating churches (church members and their families and friends)
    • 3. Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mm Hg
    • 4. Willing and able to participate in the intervention.
    • 5. Willing and able to sign written informed consent.

    Exclusion Criteria:

    • 1. Prior hospitalization in the last 3 months for chronic heart failure or heart attack
    • 2. Current diagnosis of cancer requiring chemotherapy or radiation therapy
    • 3. Stage-5 chronic kidney disease requiring chronic dialysis or transplant
    • 4. Pregnant or planning to become pregnant in the next 18 months
    • 5. Planning to move out of the Greater New Orleans area during the next year
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 November 2023
  • First Submitted that Met QC Criteria 10 November 2023
  • First Posted 15 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 May 2024
  • Last Update Posted 16 May 2024
  • Last Verified May 2024