NCT06133322 · Tulane University
Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)
(BLESSED)
What this study is about
The burden of hypertension and related cardiovascular diseases, stroke, and end-stage kidney disease is disproportionately high in Black populations, especially in the South.
View original scientific description
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.
Interventions
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
Primary outcome measures
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where
- New Orleans, Louisiana
Collaborators
National Institutes of Health (NIH), National Institute on Minority Health and Health Disparities (NIMHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 21, 2025 · Source of record for eligibility and locations