Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) (BLESSED)

March 18, 2025 updated by: Jiang He, MD, PhD, Tulane University

Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1176

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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
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.
Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in mean change of systolic blood pressure
Time Frame: Measured from baseline to 18 months
Difference in mean change of systolic blood pressure from baseline to 18 months between intervention and control groups
Measured from baseline to 18 months
Implementation fidelity summary score
Time Frame: Measured at 6, 12, and 18 months
The fidelity summary score is composed of the following key implementation strategy components: proportion of assigned health education sessions attended in all participants, proportion of assigned discussion sessions attended in all participants, proportion of recommended minutes of physical activity completed in all participants, proportion of days per week that fruits/vegetables are eaten as recommended in all participants, proportion of recommended home blood pressure (BP) monitoring completed in patients with hypertension, proportion of required provider visits attended in all patients, and proportion of antihypertensive medications taken in patients with hypertension. The score ranged from zero to six with a higher score indicates greater fidelity.
Measured at 6, 12, and 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nutrition Education Session Fidelity (community health worker-led strategy group)
Time Frame: Measured at 6, 12, and 18 months
Percentage of nutrition education sessions organized. Measured by study administrative data.
Measured at 6, 12, and 18 months
Exercise Session Fidelity (community health worker-led strategy group)
Time Frame: Measured at 6, 12, and 18 months
Percentage of exercise sessions organized. Measured by study administrative data.
Measured at 6, 12, and 18 months
Health Care Appointment Fidelity (community health worker-led strategy group)
Time Frame: Measured at 6, 12, and 18 months
Percentage of health care visit appointments made. Measured by study administrative data.
Measured at 6, 12, and 18 months
Sustainability (Participants)
Time Frame: Measured at 24 months
Percentage of participants maintaining ideal cardiovascular health metrics, healthy lifestyle components, and adherence to medications. Measured by 6-month post-intervention survey and examination.
Measured at 24 months
Difference in the proportion of patients with controlled BP between intervention and control groups
Time Frame: Measured from baseline to 18 months
Difference in the proportion of patients with controlled BP (<130/80 mm Hg) between intervention and control groups at 18 months
Measured from baseline to 18 months
Difference in mean change of diastolic BP
Time Frame: Measured from baseline to 18 months
Difference in mean change of diastolic BP (DBP) from baseline to 18 months between intervention and control groups
Measured from baseline to 18 months
Side effects of medications and adverse events
Time Frame: Measured from baseline to 18 months
Change in side effects of medications and adverse events from baseline to 18 months
Measured from baseline to 18 months
Cost-effectiveness
Time Frame: Measured from baseline to 18 months
Cost-effectiveness assessed as incremental direct costs per additional percentage of hypertension control
Measured from baseline to 18 months
Acceptability
Time Frame: Measured from baseline to 18 months
Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is acceptable (satisfactory). Measured by survey.
Measured from baseline to 18 months
Adoption (Churches)
Time Frame: Measured from baseline to 18 months
% of churches adopting the intervention program
Measured from baseline to 18 months
Adoption (Providers)
Time Frame: Measured from baseline to 18 months
% of invited providers attending training sessions
Measured from baseline to 18 months
Appropriateness
Time Frame: Measured from baseline to 18 months
Percentage of participants, community health workers, providers, and church administrators who reply that the intervention is appropriate (good perceived fit). The outcome will be measured by survey question.
Measured from baseline to 18 months
Feasibility to participant, community health worker, provider and churches
Time Frame: Measured from baseline to 18 months
Percentage of participants, community health worker, providers, and church administrators who reply that the intervention is feasible (actual fit, suitability). Measured by survey and study administrative data.
Measured from baseline to 18 months
Fidelity of Group Health Education Session
Time Frame: Measured at 6, 12, and 18 months
Percentage of group health education sessions conducted out of health educated sessions planned per study protocol.
Measured at 6, 12, and 18 months
Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data. Reach (Participants)
Time Frame: Measured at baseline, 6, 12, and 18 months
Percentage of enrolled participants receiving assigned intervention. Measured by study administrative data.
Measured at baseline, 6, 12, and 18 months
Reach (Participants)
Time Frame: Measured at baseline
The percentage of eligible/screened/contacted participants enrolled. Measured by study data, administrative data.
Measured at baseline
Penetrance (Participants)
Time Frame: Measured at baseline, 6, 12, and 18 months
Percentage of enrolled participants receiving assigned intervention. Measured by intervention monitoring data.
Measured at baseline, 6, 12, and 18 months
Penetrance (Providers)
Time Frame: Measured at baseline, 6, 12, and 18 months
Percentage of trained providers delivering protocol-based care. Measured by intervention monitoring data.
Measured at baseline, 6, 12, and 18 months
Penetrance (educators)
Time Frame: Measured at baseline, 6, 12, and 18 months
Percentage of trained CHWs or providers and health educators delivering health coaching. Measured by intervention monitoring data.
Measured at baseline, 6, 12, and 18 months
Sustainability (Churches)
Time Frame: Measured at baseline, 6, 12, and 18 months
Percentage of churches continuing the intervention program and individual components. Measured by 6-month post-intervention survey.
Measured at baseline, 6, 12, and 18 months
Sustainability Effectiveness Outcome: Differences in mean change of SBP and DBP
Time Frame: Measured at baseline and 24 months
Differences in mean change of SBP and DBP from baseline to 24 months (6 months post-intervention) between intervention and control groups
Measured at baseline and 24 months
Sustainability Effectiveness Outcome: Difference in the proportion of patients with controlled BP
Time Frame: Measured at baseline and 24 months
Difference in the proportion of patients with controlled BP (<130/80 mm Hg) between intervention and control groups at 24 months.
Measured at baseline and 24 months
Sustainability of Fidelity
Time Frame: Measured at 24 months
A fidelity summary score for key implementation strategy components at 6 months post-intervention (24 months overall). The fidelity summary score is composed of the following key implementation strategy components: proportion of assigned health education sessions attended in all participants, proportion of assigned discussion sessions attended in all participants, proportion of recommended minutes of physical activity completed in all participants, proportion of days per week that fruits/vegetables are eaten as recommended in all participants, proportion of recommended home BP monitoring completed in patients with hypertension, proportion of required provider visits attended in all patients, and proportion of antihypertensive medications taken in patients with hypertension. Fidelity score ranges from zero to six with a higher score indicates greater fidelity.
Measured at 24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: Measured from baseline to 18 months
The difference in QoL between the two arms over 18 months. QoL will be assessed using the SF-12 questionnaire. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured from baseline to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tulane University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Minority Health and Health Disparities (NIMHD)
National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-1081-SPHTM
  • R01MD018193 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. The study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). The datasets will be submitted to the NHLBI no later than three years after the end of the final participant follow-up or two years after the main paper of the trial has been published, whichever comes first. The NHLBI will review the submitted data prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." In addition, the investigators will offer, through a publicly accessible website, opportunities for outside investigators to collaborate using complete study data.

IPD Sharing Time Frame

No later than three years after the end of the final participant follow-up or two years after the main paper of the trial has been published, whichever comes first

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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