Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
BLESSED
2 other identifiers
interventional
1,176
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hypertension
Started Nov 2023
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedFirst Posted
Study publicly available on registry
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
March 21, 2025
May 1, 2024
2.8 years
November 1, 2023
March 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Difference in mean change of systolic blood pressure
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
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 Outcomes (23)
Difference in the proportion of patients with controlled BP between intervention and control groups
Measured from baseline to 18 months
Difference in mean change of diastolic BP
Measured from baseline to 18 months
Side effects of medications and adverse events
Measured from baseline to 18 months
Cost-effectiveness
Measured from baseline to 18 months
Acceptability
Measured from baseline to 18 months
- +18 more secondary outcomes
Other Outcomes (1)
Change in quality of life
Measured from baseline to 18 months
Study Arms (2)
Community health worker-led implementation strategy
EXPERIMENTALCHW-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-based Education Strategy
EXPERIMENTALThe 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
The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension
Eligibility Criteria
You may qualify if:
- Men or women aged ≥18 years
- Community members associated with the participating churches (church members and their families and friends)
- Systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mm Hg
- Willing and able to participate in the intervention.
- Willing and able to sign written informed consent.
You may not qualify if:
- Prior hospitalization in the last 3 months for chronic heart failure or heart attack
- Current diagnosis of cancer requiring chemotherapy or radiation therapy
- Stage-5 chronic kidney disease requiring chronic dialysis or transplant
- Pregnant or planning to become pregnant in the next 18 months
- Planning to move out of the Greater New Orleans area during the next year
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tulane University
New Orleans, Louisiana, 70112, United States
Related Publications (3)
Maroney K, Laurent J, Alvarado F, Gabor A, Bell C, Ferdinand K, He J, Mills KT. Systematic review and meta-analysis of church-based interventions to improve cardiovascular disease risk factors. Am J Med Sci. 2023 Sep;366(3):199-208. doi: 10.1016/j.amjms.2023.05.010. Epub 2023 May 25.
PMID: 37244637BACKGROUNDHe J, Bundy JD, Geng S, Tian L, He H, Li X, Ferdinand KC, Anderson AH, Dorans KS, Vasan RS, Mills KT, Chen J. Social, Behavioral, and Metabolic Risk Factors and Racial Disparities in Cardiovascular Disease Mortality in U.S. Adults : An Observational Study. Ann Intern Med. 2023 Sep;176(9):1200-1208. doi: 10.7326/M23-0507. Epub 2023 Aug 15.
PMID: 37579311BACKGROUNDBundy JD, Mills KT, He H, LaVeist TA, Ferdinand KC, Chen J, He J. Social determinants of health and premature death among adults in the USA from 1999 to 2018: a national cohort study. Lancet Public Health. 2023 Jun;8(6):e422-e431. doi: 10.1016/S2468-2667(23)00081-6.
PMID: 37244672BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director Tulane University Translational Science Institute
Study Record Dates
First Submitted
November 1, 2023
First Posted
November 15, 2023
Study Start
November 1, 2023
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
March 21, 2025
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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
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.