Community Health Worker Program for Cardiovascular Disease

(H2H Trial)

Recruiting at 1 trial location

Overseen By Lena Mathews, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Dementia, Severe psychiatric disorders, others

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

Compensation: Varies

Number of Visits: 7

50 Participants Needed

Trial Summary

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's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Heart to Heart in the Community Health Worker Program for Cardiovascular Disease?

Research shows that community health workers can effectively help reduce the risk of heart disease by identifying and managing risk factors like high blood pressure and unhealthy lifestyle habits. Programs using community health workers have been successful in improving heart health in various communities, suggesting that the Heart to Heart treatment could be effective in similar ways. ^{1 2 3 4 5}

Is the Community Health Worker Program for Cardiovascular Disease safe for humans?

Research shows that Community Health Workers (CHWs) are effective in improving care for chronic diseases like heart disease and high blood pressure, and they help people access and stick to their treatments. There is no specific mention of safety issues, suggesting that the program is generally considered safe for humans. ^{1 3 6 7 8}

How does the Community Health Worker Program for Cardiovascular Disease differ from other treatments?

This treatment is unique because it uses community health workers (CHWs) to prevent and manage cardiovascular disease, especially in underserved populations. Unlike traditional medical treatments, this approach focuses on community-based interventions and education to reduce risk factors and improve health outcomes. ^{1 2 6 9 10}

What is the purpose of this trial?

This study is being done to evaluate whether a program called Heart to Heart, that helps patients make a more informed decision about cardiac rehab (CR), is interesting, acceptable to participants, and whether participants would recommend it to others.

Research Team

Lena Matthews, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for individuals with cardiovascular disease who are considering cardiac rehabilitation (CR). The study aims to help patients make informed decisions about CR and assess the program's appeal and recommendation potential.

Inclusion Criteria

Low socioeconomic status defined by Medicaid insurance, or top quartile of the area deprivation index in Baltimore city

Willing to be audio-recorded

I am 21 years old or older.

Exclusion Criteria

Formal diagnosis of dementia or cognitive impairment in the Electronic Health Record (EHR) that would prohibit completion of study activities

I do not have a severe psychiatric disorder that would stop me from completing study tasks.

Unwilling or unable to follow study procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline survey and medical record abstraction is conducted

1 week

1 visit (in-person or virtual)

Intervention

Participants receive the H2H intervention with 4 to 8 coaching sessions over 3 months

3 months

4-8 sessions (telephone/video chat)

Follow-up

Participants are monitored for changes in health-related quality of life, depressive symptoms, perceived stress, and physical activity

3 months

2 visits (in-person or virtual)

Long-term Follow-up

Participants are monitored for all-cause hospitalization and mortality

6 months

Treatment Details

Interventions

• Heart to Heart

Trial Overview The intervention being tested is a program called Heart to Heart, which includes education, social support, and assistance with navigating the health system to increase participation in cardiac rehab.

Participant Groups

Group I: H2H Intervention Experimental Treatment 1 Intervention

Providing the H2H Intervention to Participants

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

A community health worker (CHW) program in rural Colorado successfully improved coronary heart disease (CHD) risk factors among 4743 participants, with significant enhancements in diet, weight, blood pressure, and lipid levels.

Participants who had successful follow-up interactions with CHWs showed a statistically significant reduction in their 10-year Framingham Risk Score, indicating that personalized support and referrals were effective in managing CHD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a community health worker cardiovascular risk reduction program in public health and health care settings. Krantz, MJ., Coronel, SM., Whitley, EM., et al.[2021]

Community health workers (CHWs) have shown effectiveness in managing cardiovascular risk factors in low- and middle-income countries, as evidenced by 11 studies, including 4 randomized controlled trials.

Eight of these studies reported positive outcomes, such as reduced blood pressure and blood glucose levels, increased smoking cessation rates, and improved diet and physical activity among participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Community Health Workers for CVD Prevention in LMIC. Khetan, AK., Purushothaman, R., Chami, T., et al.[2022]

A study involving 105 rural high-risk adults showed that a Community Health Worker (CHW) intervention significantly reduced blood pressure and body weight, indicating its effectiveness in managing cardiovascular disease risk factors.

Participants experienced a mean reduction of 5.4 mmHg in systolic blood pressure and 3.8 lbs in body weight after receiving 80% of the planned intervention visits, demonstrating the potential of CHWs in improving health outcomes in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strengthening community-clinical linkages to reduce cardiovascular disease risk in rural NC: feasibility phase of the CHANGE study. Samuel-Hodge, CD., Gizlice, Z., Allgood, SD., et al.[2022]

Community health workers (CHWs) significantly improve care quality and health outcomes for chronic diseases, particularly hypertension, by enhancing access to care and treatment adherence among underserved populations.

CHWs play vital roles in patient education, monitoring health, and facilitating communication between patients and providers, but challenges remain in integrating them into healthcare teams effectively, requiring sustainable funding and policy changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers as interventionists in the prevention and control of heart disease and stroke. Brownstein, JN., Bone, LR., Dennison, CR., et al.[2022]

References

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

Effectiveness of a community health worker cardiovascular risk reduction program in public health and health care settings. [2021]

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

Referral outcomes of individuals identified at high risk of cardiovascular disease by community health workers in Bangladesh, Guatemala, Mexico, and South Africa. [2022]

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

A Hybrid Implementation-Effectiveness Study of a Community Health Worker-Delivered Intervention to Reduce Cardiovascular Disease Risk in a Rural, Underserved Non-Hispanic Black Population: The CHANGE Study. [2022]

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

Salud Para Su Corazon (health for your heart) community health worker model: community and clinical approaches for addressing cardiovascular disease risk reduction in Hispanics/Latinos. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of Community Health Workers for CVD Prevention in LMIC. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Strengthening community-clinical linkages to reduce cardiovascular disease risk in rural NC: feasibility phase of the CHANGE study. [2022]

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

Community health workers as interventionists in the prevention and control of heart disease and stroke. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

Challenges Facing Successful Scaling Up of Effective Screening for Cardiovascular Disease by Community Health Workers in Mexico and South Africa: Policy Implications. [2023]

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

Effectiveness of community health worker training programmes for cardiovascular disease management in low-income and middle-income countries: a systematic review. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Cardiovascular disease prevention in Ghana: feasibility of a faith-based organizational approach. [2021]