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?

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.

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.

Is the treatment generally safe for humans?

The treatment strategies, including lifestyle changes and community health worker interventions, are generally safe and focus on improving diet, physical activity, and medication adherence to manage high blood pressure. ^{1 2 3 4 5}

How is the Community Health Worker-led multifaceted intervention treatment for high blood pressure different from other treatments?

This treatment is unique because it involves community health workers who provide culturally sensitive education and support to help people follow lifestyle changes and medication plans, which can improve blood pressure control. Unlike traditional treatments that focus solely on medication, this approach emphasizes community involvement and lifestyle modifications, such as diet and physical activity, to manage high blood pressure. ^{3 6 7 8 9}

What data supports the effectiveness of this treatment for lowering high blood pressure?

Research shows that community-based programs, including those led by community health workers, can effectively improve blood pressure control by raising awareness and promoting healthy lifestyle changes. Additionally, lifestyle interventions recommended by the 2017 ACC/AHA hypertension guideline can reduce the need for medication by lowering blood pressure to safer levels. ^{1 2 3 6 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

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]

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]

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]

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]

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]

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]

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 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]

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]

Citations

1. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Lifestyle Interventions Reduce the Need for Guideline-Directed Antihypertensive Medication. [2023]

3. India 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Role of community programs in controlling blood pressure. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Hypertension guideline update: A new guideline for a new era. [2018]

6. Belgium pubmed.ncbi.nlm.nih.gov

[Treatment of arterial hypertension: 1993 recommendations]. [2006]

7. United States pubmed.ncbi.nlm.nih.gov

Heart 2 Heart: Pilot Study of a Church-Based Community Health Worker Intervention for African Americans with Hypertension. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The primary prevention of high blood pressure: a population approach. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Physical activity recommendation for hypertension management: does healthcare provider advice make a difference? [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Primary prevention of hypertension: clinical and public health advisory from The National High Blood Pressure Education Program. [2022]