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Behavioral Intervention

Blood Pressure Lowering Strategies for High Blood Pressure (BLESSED Trial)

N/A

Recruiting

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Black or African American men or women aged ≥18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 6, 12, and 18 months

Awards & highlights

BLESSED Trial Summary

This trial aims to reduce hypertension disparities in Black communities in the US using a CHW-led intervention in churches.

Who is the study for?

The BLESSED trial is for Black adults with high blood pressure who are part of the Greater New Orleans area churches. Participants must be willing to join the study, sign consent, and have a systolic BP ≥130 mmHg or diastolic BP ≥80 mmHg. Excluded are those recently hospitalized for heart issues, undergoing cancer treatment, on chronic dialysis or transplant due to kidney disease, pregnant or planning pregnancy soon.Check my eligibility

What is being tested?

This trial tests a community health worker-led intervention based on the latest hypertension guidelines against enhanced usual care in Black communities. The goal is to see if this approach can better control high blood pressure over an 18-month period with follow-up at 24 months.See study design

What are the potential side effects?

Since this trial focuses on behavioral interventions rather than medications, side effects may include discomfort from lifestyle changes such as diet and exercise adjustments but no medical side effects like those from drugs.

BLESSED Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a Black or African American adult.

BLESSED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 6, 12, and 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 6, 12, and 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 6, 12, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Difference in mean change of systolic blood pressure

Implementation fidelity summary score

Secondary outcome measures

Acceptability

Adoption (Churches)

Adoption (Providers)

+20 more

Other outcome measures

Change in quality of life

BLESSED Trial Design

2Treatment groups

Experimental Treatment

Group I: Group-based Education StrategyExperimental Treatment1 Intervention

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 II: Community health worker-led implementation strategyExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,505,674 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,215,183 Total Patients Enrolled

Tulane UniversityLead Sponsor

115 Previous Clinical Trials

225,326 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unoccupied slots available in this medical experiment?

"As reported on clinicaltrials.gov, this medical trial has ceased recruitment of patients. The study was initially posted in November 1st 2023 and its last update occurred on the 10th day of that month. Although not currently looking for research participants, there are 776 other trials actively seeking enrolment at present."

Answered by AI

What are the key objectives of this investigation?

"The primary objective of this experiment, spanning 18 months from the initial baseline, is to measure adherence to implementation strategies. Secondary goals include comparison in diastolic blood pressure (DBP) between intervention and control groups over time, assessing sustaining fidelity with a score ranging from 0 to 6 wherein higher numbers reflect greater commitment, as well medication side effects and adverse events changes. This scoring system encompasses attendance at health education sessions; discussion session participation; physical activity duration; fruits/vegetables consumption rate per week; home BP monitoring frequency for hypertensive patients; provider visit reliability among all patients involved and antihypertensive medications taken by those suffering hypertension"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)

Jiang He, MD, PhD 2023. "Blood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06133322.

All > New Orleans