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

225 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Health for Hearts United Delivery of Health, Health for Hearts United Planning for Health, Health for Hearts United Preparing for Health?

The research shows that coordinated quality improvement programs and disease management strategies have improved patient outcomes in heart failure and cardiovascular care, suggesting that similar approaches in the Health for Hearts United treatment could be effective in reducing cardiovascular disease. ^{1 2 3 4 5}

How is the Health for Hearts United treatment different from other cardiovascular disease treatments?

The Health for Hearts United treatment is unique because it combines lifestyle changes, risk factor control, and disease management strategies to prevent cardiovascular disease, focusing on increasing public awareness and implementing effective prevention programs. ^{6 7 8 9 10}

What is the purpose of this trial?

This proposed project will determine the effectiveness of Health for Hearts United Collaborative (HHUC) implementation strategies in relation to process outcomes and reducing cardiovascular disease (CVD) risk in African Americans (AAs),examining two possible strategies.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Outcomes measurement. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

First results of a national initiative to enable quality improvement of cardiovascular care by transparently reporting on patient-relevant outcomes. [2017]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiac surgical outcomes improvement led by a physician champion working with a nurse clinical coordinator. [2022]

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

The results of a randomized trial of a quality improvement intervention in the care of patients with heart failure. The MISCHF Study Investigators. [2019]

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

An evidence-based approach to improving care of patients with heart failure across the continuum. [2019]

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

Effects of Dietary Approaches to Stop Hypertension (DASH)-style diet on fatal or nonfatal cardiovascular diseases--incidence: a systematic review and meta-analysis on observational prospective studies. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Interventions for cardiovascular disease prevention. [2011]

8. Ukraine pubmed.ncbi.nlm.nih.gov

[Vertical integration--an important component of rehabilitation of patients with stroke]. [2016]

9. England pubmed.ncbi.nlm.nih.gov

Knowledge assessment regarding secondary prevention of coronary heart disease--a multi centre survey. [2021]

10. Chile pubmed.ncbi.nlm.nih.gov

[Achievement of cardiovascular prevention goals, pharmacologic prescription and major cardiovascular events among patients with coronary disease]. [2013]