Blood Pressure Lowering Strategies for High Blood Pressure

(BLESSED Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Heart failure, Cancer, Kidney disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 18 months

1176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to manage high blood pressure in Black communities in the Greater New Orleans area. It will test two approaches: group education and personalized coaching and support led by community health workers. The goal is to determine which method more effectively helps people maintain blood pressure control over time. Individuals with frequent blood pressure readings of 130/80 or higher who are part of the participating churches may be suitable candidates for this trial. As an unphased trial, this study offers participants the opportunity to contribute to community-focused research that seeks to improve health outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this multifaceted intervention is safe for hypertension control?

Research has shown that programs led by community health workers are usually safe and well-received by patients. For instance, a study in Argentina found that community health workers effectively managed blood pressure without major safety concerns. Patients in these programs receive support through education and health coaching, which are simple and focus on lifestyle changes. Another study found similar results, indicating that these programs do not cause significant side effects. This evidence suggests that the approach used in this trial should be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these blood pressure-lowering strategies because they focus on community-driven, personalized health interventions rather than traditional medication alone. Unlike standard treatments that often rely on individual prescriptions and clinic visits, these strategies involve group-based education and community health worker-led initiatives within church settings. The group-based approach integrates local primary care providers, dieticians, and educators to foster a supportive learning environment, while the community health worker-led strategy offers personalized coaching and brings healthcare directly to patients' homes. This innovative approach could empower individuals to manage their blood pressure more effectively by making healthcare accessible and tailored to their communities.

What evidence suggests that this trial's treatments could be effective for hypertension?

Research has shown that programs led by community health workers (CHWs), which participants in this trial may receive, can effectively lower high blood pressure. These programs often include health coaching and support, which have significantly reduced blood pressure levels. For instance, a study in Argentina found that a similar CHW-led program helped low-income patients better control their blood pressure. Additionally, programs led by non-doctors have successfully reduced heart problems and death rates.

Another group of participants in this trial will receive group education sessions that follow well-established guidelines for managing high blood pressure. These sessions use the 2017 ACC/AHA guidelines, supported by evidence showing they effectively lower blood pressure. Both methods in this trial aim to help participants better manage their high blood pressure. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to sign written informed consent

People who are part of the churches involved in the study (church members, their families, and friends).

Your blood pressure is higher than 130/80 mmHg.

Exclusion Criteria

I have advanced kidney disease and need dialysis or have had a transplant.

I was hospitalized for heart failure or a heart attack in the last 3 months.

I need chemotherapy or radiation for my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a CHW-led multifaceted intervention for hypertension control, including health coaching, exercise, and medication adherence support

18 months

Regular visits at 6, 12, and 18 months

Follow-up

Participants are monitored for sustainability of intervention effects and health outcomes

6 months post-intervention

1 visit at 24 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

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.

How Is the Trial Designed?

Group I: Group-based Education Strategy Experimental Treatment 1 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 strategy Experimental Treatment 1 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.

Behavioral: Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline is already approved in United States for the following indications:

Approved in United States as Evidence-based interventions recommended by the 2017 ACC/AHA hypertension clinical guideline for:

• Hypertension control in Black communities

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Community-based programs have been effective in raising awareness and promoting healthier behaviors to control high blood pressure, emphasizing partnerships and resident involvement in screening and education.

Utilizing trained community health workers to deliver culturally sensitive education on heart health has been shown to enhance the effectiveness of these programs, potentially leading to better blood pressure management in communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of community programs in controlling blood pressure. Fulwood, R., Guyton-Krishnan, J., Wallace, M., et al.[2019]

Only about one-third of hypertensive patients received counseling from healthcare providers to engage in physical activity, despite its importance in managing blood pressure.

Patients who followed physical activity recommendations experienced an average reduction in systolic blood pressure of 3-4 mm Hg, highlighting the effectiveness of counseling when it occurs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity recommendation for hypertension management: does healthcare provider advice make a difference? Halm, J., Amoako, E.[2018]

The updated recommendations for preventing hypertension emphasize both a population-based approach and targeted strategies for individuals at high risk, highlighting the importance of addressing hypertension on multiple levels.

Six effective strategies for hypertension prevention include engaging in moderate physical activity, maintaining a healthy weight, limiting alcohol and sodium intake, ensuring adequate potassium consumption, and following a diet rich in fruits, vegetables, and low-fat dairy while reducing saturated fats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary prevention of hypertension: clinical and public health advisory from The National High Blood Pressure Education Program. Whelton, PK., He, J., Appel, LJ., et al.[2022]

Recent guidelines emphasize the importance of thorough evaluation of hypertension and cardiovascular risk factors before starting treatment, ensuring a tailored approach to managing high blood pressure.

Lifestyle modifications, such as weight loss, regular exercise, and sodium restriction, are strongly recommended alongside initial drug therapy, which typically includes low-dose diuretics or beta-blockers, depending on individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of arterial hypertension: 1993 recommendations]. Leeman, M.[2006]

In a study of 144 adults with untreated hypertension, lifestyle modifications, specifically the DASH diet combined with behavioral weight management, significantly reduced the 10-year cardiovascular disease risk from 5.7% to 4.4%.

These lifestyle changes also led to a dramatic decrease in the number of participants needing antihypertensive medication, dropping from 51% to 18% in the DASH + weight management group, highlighting the efficacy of non-pharmacological interventions in managing blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Interventions Reduce the Need for Guideline-Directed Antihypertensive Medication. Hinderliter, AL., Smith, P., Sherwood, A., et al.[2023]

A unified community-based approach to prevent high blood pressure is essential, emphasizing lifestyle changes that are safe and culturally appropriate, which can lead to significant health benefits.

Combining medical strategies with community programs can enhance the effectiveness of hypertension prevention efforts, highlighting the importance of collaboration between health professionals and community leaders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The primary prevention of high blood pressure: a population approach. Blackburn, H., Grimm, R., Luepker, RV., et al.[2019]

Hypertension affects approximately one-third of adults in the U.S. and is a major contributor to serious health issues, including stroke and heart failure, highlighting the importance of effective management.

The 2017 ACC/AHA guidelines introduced significant changes, including reclassifying blood pressure stages and lowering treatment goals, which aim to improve hypertension management and reduce related health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension guideline update: A new guideline for a new era. DePalma, SM., Himmelfarb, CD., MacLaughlin, EJ., et al.[2018]

A pilot study involving 79 African American adults with poorly controlled hypertension showed that a church-based community health worker (CHW) intervention led to a significant average reduction in systolic blood pressure of -5 mm/Hg over 6 months, with greater reductions in those with higher baseline blood pressure.

Participants reported high acceptability of the intervention, preferring it to clinical settings, although the intervention's implementation fidelity was low, indicating that while the approach is promising, improvements in adherence to the intervention protocol are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart 2 Heart: Pilot Study of a Church-Based Community Health Worker Intervention for African Americans with Hypertension. Lynch, EB., Tangney, C., Ruppar, T., et al.[2023]

A community intervention targeting hypertension in predominantly racial/ethnic minority neighborhoods led to significant blood pressure improvements, especially in individuals with severely elevated blood pressure (≥160/100 mmHg), who saw a reduction from 165.4/98.3 mmHg to 150.4/90.8 mmHg.

After 3 months, 55.2% of participants with severely elevated blood pressure achieved controlled levels, demonstrating the effectiveness of education and empowerment strategies in managing hypertension in high-risk communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Targeting of Uncontrolled Hypertension: Results of a Hypertension Screening and Education Intervention in Community Churches Serving Predominantly Racial/Ethnic Minority Populations. Prendergast, HM., Escobar-Schulz, S., Del Rios, M., et al.[2022]

Structured health education for community health workers significantly improved hypertensive patients' knowledge about hypertension, leading to better medication adherence, which increased from 20% to 70%.

The intervention also resulted in a notable improvement in low salt diet compliance among patients, rising from 39% to 85%, while the control group showed no significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Intervention Study for Impact Assessment of Health Education by Empowered Community Health Workers in Improving Treatment and Diet Adherence in Hypertension. Lukitasari, M., Nugroho, DA., Rohman, MS., et al.[2022]

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