Heart Matters Program for Cardiovascular Disease

(Co-LEARN Trial)

Recruiting at 10 trial locations

Overseen By Kristen Witkemper, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Unstable cardiovascular disease, Cognitive impairment

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: 6

Duration: 12 months

173 Participants Needed

Trial Summary

Do I need to stop my current medications to join the 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 Heart Matters Program treatment for cardiovascular disease?

The effectiveness of the Heart Matters Program for cardiovascular disease may be supported by similar programs that focus on outcomes management, which have shown improved patient outcomes in heart failure and coronary artery disease by regularly measuring and providing feedback on patient progress. ^{1 2 3 4 5}

What makes the Heart Matters Program treatment unique for cardiovascular disease?

The Heart Matters Program is unique because it focuses on a multidisciplinary, behavior-oriented approach that includes lifestyle changes like diet and exercise, similar to the Heart Smart Program, which has shown positive results in reducing cardiovascular risk factors in families. This program is adaptable to clinical practice and emphasizes active communication between patients and health professionals to improve health outcomes. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this non-randomized, propensity-matched-controlled study is to assess the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy in NCT02707432 -- in improving cardiovascular health outcomes (change in systolic and diastolic blood pressure, primary outcomes) when implemented by community-based facilitators.

Research Team

Gaurav Dave, MBBS, DrPH

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for individuals with cardiovascular disease living in rural areas. Participants should be interested in improving their heart health and willing to work with community-based facilitators.

Inclusion Criteria

Identify as Black or African American

Reside in rural, eastern North Carolina

I have a risk factor for heart disease like pre-diabetes, high blood pressure, obesity, or a family history of it.

Exclusion Criteria

I am able to understand and give informed consent.

I have heart problems that are currently not stable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Heart Matters intervention delivered by community-based facilitators

12 months

Regular visits as per intervention schedule

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up assessments at 6 and 12 months

Treatment Details

Interventions

• Heart Matters

Trial Overview The study tests the 'Heart Matters' program, which aims to improve blood pressure (both systolic and diastolic) as primary outcomes. It's a non-randomized study comparing participants who receive the program against those who do not.

Participant Groups

Group I: Intervention Group Experimental Treatment 1 Intervention

This group will receive the Heart Matters intervention, delivered by community-based facilitators. All participants consenting to the present study will be assigned to this arm.

Group II: Propensity-matched Control Group (Retrospective) Active Control 1 Intervention

This group received the Heart Matters intervention, delivered by researchers, under NCT02707432.

Heart Matters is already approved in United States for the following indications:

Approved in United States as Heart Matters Program for:

• Cardiovascular health improvement
• Hypertension management

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

James McFarlin Community Development, Inc.

Collaborator

Trials

2

Recruited

350+

Opportunities Industrialization Center, Inc.

Collaborator

Trials

1

Recruited

210+

Project Momentum, Inc.

Industry Sponsor

Trials

2

Recruited

350+

James McFarlin Community Development, Inc.

Collaborator

Trials

2

Recruited

350+

Findings from Research

The International Consortium for Health Outcomes Measurement (ICHOM) has established a consensus standard set of 13 outcome measures for tracking and improving care in patients with coronary artery disease (CAD), which includes both immediate and long-term health outcomes.

These measures are designed to be applicable to all CAD patients, including those with acute myocardial infarction and asymptomatic CAD, and aim to enhance the quality of care by providing relevant data for physicians and hospitals to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). McNamara, RL., Spatz, ES., Kelley, TA., et al.[2022]

St. Luke's Episcopal Hospital has successfully improved patient outcomes in interventional cardiology over a decade by implementing an outcomes management approach.

The article details the specific processes used and the positive results achieved, highlighting the effectiveness of structured management in enhancing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenge of managing interventional cardiology patients over a decade. Scroggins, NM., Houston, S., Clark, M., et al.[2019]

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]

The heart failure program implements innovative strategies like quarterly monitoring reports and customized patient summary sheets to enhance patient outcomes.

Care management programs are also a key component of the initiative, aiming to provide tailored support for individuals with heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kaiser Permanente reports improved outcomes for heart failure patients. [2007]

The CABG outcomes management program has led to ongoing improvements in the effectiveness and efficiency of care for patients undergoing coronary artery bypass grafting (CABG), demonstrating a commitment to continuous quality enhancement.

The success of this program has inspired the development of similar quality improvement initiatives for other patient populations, highlighting its positive impact on both patient care and organizational outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linking outcomes management and practice improvement. The link between outcomes management and JCAHO functions. Luquire, R., Houston, S.[2019]

The HEARTS initiative in Mexico aims to improve cardiovascular disease management through a 'Healthy-lifestyle counselling' module, emphasizing a person-centered approach in primary health care.

An interdisciplinary advisory group was crucial in designing the implementation of this module, promoting effective communication between patients and health professionals to enhance patient engagement and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Implementation design of the HEARTS healthy-lifestyle counselling module at the first level of care in MexicoDelineamento da implementação do módulo de hábitos e estilos de vida saudáveis da Iniciativa HEARTS na atenção primária do México]. González, N., Vega, L., Gloria, L., et al.[2022]

The 'Heart Smart' cardiovascular health project, implemented in a K-6 school environment through collaboration among a medical school, university, and community, demonstrates the effectiveness of interdisciplinary approaches in promoting heart health among children.

Preliminary findings suggest that comprehensive health promotion models like 'Heart Smart' are essential for reducing cardiovascular disease risk, highlighting the importance of engaging multiple professionals in health education initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health promotion model for "Heart Smart": the medical school, university, and community. Downey, AM., Greenberg, JS., Virgilio, SJ., et al.[2007]

The Heart Smart Family Health Promotion Program, involving 19 high-risk children and 23 parents over 12 weeks, successfully improved eating habits, physical activity, and cardiovascular knowledge, leading to significant health benefits.

Both children and parents experienced positive changes, including reduced blood pressure and stabilized weight gain in children, demonstrating the program's effectiveness as a cardiovascular risk intervention that can be adapted for clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular intervention for high-risk families: the Heart Smart Program. Johnson, CC., Nicklas, TA., Arbeit, ML., et al.[2019]

A modified version of the Cardiovascular Health Awareness Program (CHAP) was implemented for 281 adults on a waiting list for primary care, revealing that many participants had significant cardiovascular disease (CVD) risk factors, including high blood pressure and a high risk for diabetes.

The program successfully referred 41.6% of participants to local health promotion programs or medical assistance, highlighting the potential benefits of community-based interventions for individuals lacking regular access to primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Modified Cardiovascular Health Awareness Program for Canadian Adults on a Waiting List for a Family Physician. Kaczorowski, J., Lussier, MT., Girard, M., et al.[2021]

The Canadian Heart Health Initiative has successfully shifted its focus from single-disease strategies to integrated chronic disease prevention, enhancing public health capacity through partnerships and resource development.

Key informant interviews and policy reviews revealed that the initiative has effectively placed chronic disease prevention on health agendas and provided community-based models for public health policy development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From heart health promotion to chronic disease prevention: contributions of the Canadian Heart Health Initiative. Robinson, K., Farmer, T., Elliott, SJ., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Standardized Outcome Measurement for Patients With Coronary Artery Disease: Consensus From the International Consortium for Health Outcomes Measurement (ICHOM). [2022]

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

Challenge of managing interventional cardiology patients over a decade. [2019]

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

Outcomes measurement. [2019]

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

Kaiser Permanente reports improved outcomes for heart failure patients. [2007]

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

Linking outcomes management and practice improvement. The link between outcomes management and JCAHO functions. [2019]

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

[Implementation design of the HEARTS healthy-lifestyle counselling module at the first level of care in MexicoDelineamento da implementação do módulo de hábitos e estilos de vida saudáveis da Iniciativa HEARTS na atenção primária do México]. [2022]

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

Health promotion model for "Heart Smart": the medical school, university, and community. [2007]

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

Cardiovascular intervention for high-risk families: the Heart Smart Program. [2019]

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

Implementation of Modified Cardiovascular Health Awareness Program for Canadian Adults on a Waiting List for a Family Physician. [2021]

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

From heart health promotion to chronic disease prevention: contributions of the Canadian Heart Health Initiative. [2018]