Health Strategies for Cardiovascular Disease Reduction

(HHUC Trial)

Overseen By

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Non-African American, Under 18, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to identify the most effective way to help African Americans reduce their risk of cardiovascular disease through community health programs. It will test three approaches: collaborating with internal leaders (Health for Hearts United Delivery of Health), involving expert professionals (Health for Hearts United Planning for Health), and using a comparison group (Health for Hearts United Preparing for Health). The study seeks African American participants who have not been hospitalized or experienced major medical issues in the past six months. As an unphased trial, it offers participants the opportunity to contribute to important research that could improve community health strategies.

Do I need to stop taking my current medications for this trial?

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

What prior data suggests that these health strategies are safe for reducing cardiovascular disease risk in African Americans?

Research has shown that the Health for Hearts United (HHU) strategies are safe and help lower the risk of heart disease. These strategies improve community health by involving local health leaders to promote heart-healthy activities.

Early results indicate that participants experience few side effects because the strategies rely on education and support rather than medication or surgery, making the program generally safe. The HHU approach, tested in churches, has shown promise in reducing heart disease risk, especially among African Americans.

In summary, the HHU strategies focus on community and education, making them likely to be safe and well-received by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Health for Hearts United strategies because they aim to empower communities in a novel way to improve cardiovascular health. Unlike typical medical treatments that focus on medications or procedures, these strategies involve training health leaders in churches to plan and implement heart health programs. This approach leverages the influence of local leaders and professionals to foster community-wide lifestyle changes. By focusing on education, leadership, and community engagement, these strategies could offer a sustainable and supportive framework for reducing cardiovascular disease risk.

What evidence suggests that this trial's strategies could be effective for reducing cardiovascular disease risk in African Americans?

Research has shown that the "Health for Hearts United" strategies aim to reduce heart disease risk in African Americans. In this trial, participants may engage in different strategies. The Internal Champion (IC) Strategy, which trains health leaders within churches, shows promise in encouraging healthy changes. These leaders use strong leadership skills to plan and promote heart health activities effectively.

Another arm of the trial, the Expert Professional (EP) Strategy, involves outside professionals assisting church health leaders. This approach also appears promising, as it provides structured support for planning heart health programs. Both strategies focus on empowering community leaders to improve heart health, and early results suggest they could be effective. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for African American adults over the age of 18 who haven't been pregnant or hospitalized with a significant medical condition in the past six months. It aims to reduce cardiovascular disease risk within this group.

Inclusion Criteria

Not pregnant in the last six months

I haven't been hospitalized or had a serious illness in the last 6 months.

African American

Exclusion Criteria

Pregnant in the last six months

Not being African American

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Planning for Health

Health leaders are identified and trained in transformational leadership principles or assisted by external professionals to plan cardiovascular health programming

12 months

Regular meetings with health leaders

Implementation and Monitoring

Implementation of health interventions and monitoring of process outcomes, including participant reach and intervention adoption

12 months

Ongoing monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health for Hearts United Delivery of Health
• Health for Hearts United Planning for Health
• Health for Hearts United Preparing for Health

Trial Overview The effectiveness of two strategies by Health for Hearts United Collaborative (HHUC) is being tested to see how well they work at reducing cardiovascular disease risk and improving health processes among African Americans.

How Is the Trial Designed?

Group I: Internal Champion (IC) Strategy Experimental Treatment 3 Interventions

In the Planning for Health intervention, the IC implementation strategy will include trainings on transformational leadership principles that address challenges that health leaders face in the church setting to assist them in independently planning the cardiovascular health programming for congregants. Limited assistance from staff will be provided in the Preparing for Health and the Delivery of Health interventions.

Group II: Expert Professional (EP) Strategy Experimental Treatment 3 Interventions

In the Planning for Health intervention, the EP implementation strategy will include the use of external professionals to assist health leaders in the planning of cardiovascular health programming for congregants. Staff will assist health leaders in the Preparing for Health and the Delivery of Health interventions.

Group III: Comparison Group Strategy Active Control 1 Intervention

In the Planning for Health intervention, the Comparison Group strategy will include process activities with the health leaders (identification of health leaders, meetings of health leaders, assistance of health leaders with recruitment of congregants for research). Except for data collection, participants (health leaders and congregants) will not be involved in the Preparing for Health or the Delivery of Health interventions.

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

University of Georgia

Collaborator

Trials

109

Recruited

43,500+

Published Research Related to This Trial

A community hospital significantly improved its cardiac surgical outcomes through a collaborative effort between a physician champion and a nurse clinical coordinator, implementing systematic changes like nurse checklists and preoperative risk assessments.

The hospital's quality rating improved from 1 star (bottom 12%) in 2006 to 3 stars (top 12%) by 2009, demonstrating that addressing both clinical strategies and hospital culture is essential for enhancing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac surgical outcomes improvement led by a physician champion working with a nurse clinical coordinator. Stanford, JR., Swaney-Berghoff, L., Recht, K.[2022]

A new department is being established to focus on improving patient outcomes in cardiovascular care by addressing key issues like definitions, measurement, and data sources.

The initiative aims to foster discussion and research that will enhance understanding and practices related to nurse-sensitive and multidisciplinary outcomes in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes measurement. Deaton, C.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666535225000527

The Health for Hearts United Dissemination Trial We report on the implementation costs of disseminating Health for Hearts United (HH), a church-based intervention designed to reduce CVD in African Americans.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9424356/

Dissemination trial for Health for Hearts United: Model ... This paper describes the model development, preliminary health outcomes, and lessons learned from the Health for Hearts United (HHU) dissemination trial.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5245604/

The Development of Health for Hearts United This article describes Health for Hearts United, a longitudinal church-based intervention to reduce cardiovascular disease (CVD) risk in mid-life and older ...

4. researchgate.net researchgate.net/publication/312566878_The_Development_of_Health_for_Hearts_United_A_Longitudinal_Church-based_Intervention_to_Reduce_Cardiovascular_Risk_in_Mid-life_and_Older_African_Americans

A Longitudinal Church-based Intervention to Reduce ... The Development of Health for Hearts United: A Longitudinal Church-based Intervention to Reduce Cardiovascular Risk in Mid-life and Older African Americans.

5. ctv.veeva.com ctv.veeva.com/study/the-health-for-hearts-united-collaborative

The Health for Hearts United Collaborative - ClinicalTrials.Veeva This proposed project will determine the effectiveness of Health for Hearts United Collaborative (HHUC) implementation strategies in ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36052174/

Dissemination trial for Health for Hearts United - PubMed - NIH Although preliminary, the results suggest that the HHU dissemination model has promise for reducing CVD risk in AA's. Keywords: African ...

7. bhlcenter.fsu.edu bhlcenter.fsu.edu/health-hearts-united-project-dissemination-project

Health for Hearts United Project Dissemination Project The specific purpose of the Health for Hearts United Dissemination Project was to disseminate the best practices of the Reducing CVD Risk Study to 30 additional ...