Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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Louisiana residents, especially African Americans, bear a disproportionately high burden of hypertension and cardiovascular disease (CVD). In the Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) cluster randomized trial, the investigators will compare the impact of two implementation strategies - a CHW-led multifaceted strategy and a group-based education strategy - for delivering interventions recommended by the 2017 American College of Cardiology (ACC) and the American Heart Association (AHA) hypertension clinical guidelines on implementation and clinical effectiveness outcomes in predominantly Black community members over 18 months. The BLESSED study utilizes an effectiveness-implementation hybrid design to: (1). test the effectiveness of a CHW-led church-based multifaceted implementation strategy for reducing estimated CVD risk over 18 months among African American church community members at high risk for CVD, and (2). assess the implementation outcomes (acceptability, adaptation, adoption, feasibility, fidelity, penetrance, cost-effectiveness, and sustainability) simultaneously. The Exploration, Preparation, Implementation, Sustainment (EPIS) framework has guided the development and evaluation of the multifaceted implementation strategy, which includes CHW-led health coaching on lifestyle changes and medication adherence; healthcare delivery in community; church-based exercise and weight loss programs; self-monitoring of blood pressure (BP); and provider education and engagement. The CHW-led church-based intervention will provide strong social support and tackle multiple social determinants of CVD disparities. The primary clinical effectiveness outcome is the difference in mean change of systolic blood pressure (SBP) from baseline to 18 months between intervention and control groups. The primary implementation outcome is a fidelity summary score for key implementation strategy components to the CHW-led church-based multifaceted implementation strategy assessed at the participant levels. This study has 90% statistical power to detect group differences in mean SBP change of 5.8 mm Hg over 18 months using a 2-sided significance level of 0.05. The investigators will recruit 1,176 participants (28 per church) who are aged ≥18 years with systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mm Hg, and randomly assign 21 churches to intervention and 21 to control; the investigators will implement the multifaceted intervention program; the investigators will follow-up participants and collect data on effectiveness and implementation outcomes at 6, 12, and 18 months; the investigators will evaluate the sustainability of the intervention at 6 months post-intervention; and the investigators will perform intention-to-treat analyses and disseminate and scale-up the proven-effective implementation strategy. The proposed study will generate evidence on the effectiveness, implementation, and sustainability of the multifaceted intervention aimed at eliminating CVD disparities in African American populations in the US.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomization of 42 churches in New Orleans, Louisiana to 2 arms

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Clinical research coordinators and laboratory technicians who assess health-related outcomes will be blinded to intervention assignment. Study physicians who review serious adverse events and unanticipated problems will also be blinded to intervention assignment.

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No