Community Health Worker Program for Cardiovascular Disease

(H2H Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Heart to Heart program assists patients in making informed decisions about joining cardiac rehab after heart problems. The trial will assess participants' satisfaction with the program and whether they would recommend it to others. It suits individuals hospitalized for heart issues who are eligible for cardiac rehab, particularly those facing financial challenges. Participants should be comfortable with audio recording during the study. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance support for cardiac rehab decisions.

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 prior data suggests that the Heart to Heart program is safe?

Research has shown that Heart to Heart is a community program designed to help people make informed choices about heart health. While specific safety details for Heart to Heart are not provided, the program emphasizes lifestyle changes and peer support, which are generally safe and well-received.

As this program is not a medication or medical procedure, the risks are likely lower. However, participants should consider their own health needs and consult a healthcare professional before joining. Overall, Heart to Heart seems to be a supportive and educational program rather than a traditional medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Heart to Heart (H2H) Intervention because it represents a novel approach to managing cardiovascular disease by leveraging community health workers. Unlike traditional treatments that often focus on medication or lifestyle changes individually, this intervention emphasizes personalized support and education delivered by trained community members. This method aims to enhance patient engagement and adherence to treatment plans, potentially leading to better long-term health outcomes. By integrating community support, the H2H Intervention could address barriers to care that standard treatments might overlook, making it a promising addition to current cardiovascular care strategies.

What evidence suggests that the Heart to Heart program is effective for cardiovascular disease?

Research has shown that the Heart to Heart program, included in this trial as part of the H2H Intervention, helps individuals make informed decisions about heart health recovery. A previous study found it effective in reducing the 10-year risk of heart disease using a well-known calculation. The program also promotes heart health beyond regular healthcare settings by encouraging healthier lifestyle choices and preventing heart disease. Early results suggest that these community-based efforts can effectively benefit heart health. ^{6 7 8 9 10}

Who Is on the Research Team?

Lena Matthews, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11831262/

Heart2Heart: a digital peer support programme for people with ... The aim of the study is to determine whether the effectiveness of a digital peer support programme for people living with heart disease is effective.

2. hpdp.unc.edu hpdp.unc.edu/completed-research/heart-to-health/

Heart to Health The primary outcome was a reduction in the estimated 10-year risk of coronary heart disease as determined by the Framingham equation. Changes in dietary intake, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25819980/

findings from the walk your heart to health intervention - PubMed The purpose of this study was to evaluate the effectiveness of the Walk Your Heart to Health (WYHH) intervention, one component of the multilevel Community ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001349

Implementation of Evidence-Based Behavioral ... Extending cardiovascular disease prevention beyond health care settings is needed to improve population health and to advance health equity.

5. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-020-8223-x

feasibility phase of the CHANGE study - BMC Public Health This feasibility study demonstrated preliminary implementation and program effectiveness of a CHW-delivered intervention to reduce ...

6. bmjopen.bmj.com bmjopen.bmj.com/content/15/2/e088740

Heart2Heart: a digital peer support programme for people ... Heart2Heart is a community-based randomised controlled trial with 6 months follow-up for the primary outcome and 6 and 12 months for secondary outcomes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8020477/

Results of a prospective cardiovascular disease prevention ... The Cardiovascular Health Program (CHP) Registry is a 12-month, prospective study of therapeutic lifestyle change (TLC).

8. mayo.edu mayo.edu/research/centers-programs/cardiovascular-disease-outcomes-research-program/overview

Cardiovascular Disease and Outcomes Research Program The Cardiovascular Disease and Outcomes Research Program is a group of physicians and scientists working together to conduct patient-centered research.

9. ahajournals.org ahajournals.org/doi/10.1161/JAHA.124.039031

Impact of Social Determinants of Health on Cardiovascular ... In conclusion, SDoHs significantly impact cardiovascular morbidity and death and specific outcomes of patients with cardiovascular disease.

10. cdc.gov cdc.gov/cardiovascular-resources/php/data-research/surveillance-evaluation-data-resource-guide.html

Surveillance and Evaluation Data Resource Guide An at-a-glance compilation of data sources useful for heart disease and stroke prevention programs conducting policy or data surveillance and/or evaluation.