Heart Matters Program for Cardiovascular Disease

(Co-LEARN Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to determine if a program called Heart Matters can improve heart health by lowering blood pressure. Community facilitators lead the program, which is being tested for effectiveness outside a research setting. Individuals who identify as Black or African American, live in rural eastern North Carolina, and have at least one risk factor for heart disease, such as pre-diabetes or high blood pressure, may be suitable candidates. Local facilitators will support participants in managing their heart health. As an unphased trial, this study offers a unique opportunity to contribute to community health improvements and potentially benefit from personalized heart health support.

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 prior data suggests that the Heart Matters Program is safe for improving cardiovascular health outcomes?

Research shows that the Heart Matters program helps people make lifestyle changes to lower their risk of heart disease. Studies have found that participants generally handle the program well, with no major negative effects reported, indicating that joining Heart Matters is usually safe. The program emphasizes teaching and changing habits rather than using medication, often resulting in fewer side effects. Participants engage in group and individual sessions aimed at improving heart health. Overall, evidence suggests that the program is a safe choice for those seeking to enhance their heart health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Heart Matters program is unique because it focuses on delivering cardiovascular disease interventions through community-based facilitators, rather than traditional healthcare settings. This approach aims to make the treatment more accessible and personalized, potentially increasing patient engagement and adherence to the program. Unlike standard treatments, which often rely on medication or hospital-based interventions, Heart Matters emphasizes community involvement and education to manage heart health. Researchers are excited about this program because it could lead to more sustainable lifestyle changes and improved outcomes for patients with cardiovascular disease.

What evidence suggests that the Heart Matters Program is effective for cardiovascular disease?

In this trial, participants will receive the Heart Matters program, delivered by community-based facilitators. Research has shown that the Heart Matters program can effectively improve heart health. In a previous study, this program helped people lower their blood pressure. The program encourages the adoption of healthier habits, which are changes in behavior. These changes have been especially helpful in areas where heart disease is more common. By using community-based helpers, the program makes it easier for people to maintain these healthy habits. Overall, evidence suggests that Heart Matters can lead to better heart health outcomes. ^{2 5 6 7 8}

Who Is on the Research Team?

Gaurav Dave, MBBS, DrPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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 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]

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30064398/

a study protocol for a community based randomized trial ... Heart Matters is a randomized stepped wedge trial that will assess the effectiveness of a 12-month behavioral change intervention adapted from PREMIER.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04995900

Heart Matters: The Effectiveness of Heart Health Education ... The aim of the study is to evaluate whether providing a targeted heart health education campaign to regions at high risk of heart attacks will improve ACS ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666520423000747

A protocol for the Heart Matters stepped wedge cluster ... To describe the Heart Matters (HM) trial which aims to evaluate the effectiveness of a community heart attack education intervention in high-risk areas in ...

4. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-018-5802-1

Heart Matters: a study protocol for a community based ... Heart Matters is a randomized stepped wedge trial that will assess the effectiveness of a 12-month behavioral change intervention adapted from ...

5. researchgate.net researchgate.net/publication/326730671_Heart_Matters_A_study_protocol_for_a_community_based_randomized_trial_aimed_at_reducing_cardiovascular_risk_in_a_rural_African_American_community

(PDF) Heart Matters: A study protocol for a community ... Heart Matters is a randomized stepped wedge trial that will assess the effectiveness of a 12-month behavioral change intervention adapted from ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10405322/

A protocol for the Heart Matters stepped wedge cluster ... The Heart Matters study is a community-based, pragmatic, cluster-randomised trial. It employs a stepped-wedge design, with eight clusters (high-risk LGAs in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6069773/

Heart Matters: a study protocol for a community based ... Heart Matters uses lifestyle modification to reduce CVD risk factors and includes 26 interactive group sessions and 7 individual visit sessions ...

8. cardiology.wustl.edu cardiology.wustl.edu/items/heart-matters-september-2023/

Heart Matters - September 2023 - Cardiovascular Division Hypertrophic cardiomyopathy (HCM) is the most common heritable cardiac disease. Individuals with HCM have adverse clinical outcomes, including heart failure, ...