Recruiting

BLESSED

Sponsor:

Tulane University

Code:

NCT06133322

Conditions

Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline

Study Details

Brief summary:

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.

Conditions

Hypertension

Study ID

NCT06133322

Start date

Nov 1, 2023

Status verified date

May, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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

Study Design

Enrollment

1176 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Community health worker-led implementation strategy

CHW-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 Strategy

The 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.

Interventions

Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline

The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension

Primary outcome measure

  • Difference in mean change of systolic blood pressure [ Time Frame: Measured from baseline to 18 months ]
  • Implementation fidelity summary score [ Time Frame: Measured at 6, 12, and 18 months ]

Central Contacts and Locations

Locations

Tulane University

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Allison N Marshall, PhD MPH MSSW

5049886454amarshall@tulane.edu

Jodie Laurent, MPH

504-988-5432jlaurent@tulane.edu

More Information

Sponsor

Tulane University

Last update posted

Mar 21, 2025

Last verified

May, 2024

Keywords

  • church-based
  • Black
  • African American
  • Community-based Intervention
  • health disparities
  • cardiovascular disease prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tulane University on 2025-03-21.