Community Support Programs for Heart Failure

(UNLOAD-HF Trial)

Recruiting at 1 trial location

Overseen By Melissa Minotti, MPH, RPSGT, CCRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Weight loss medications

Disqualifiers: Heart failure, Uncontrolled glycemia, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a six-month program for individuals with early heart problems, type 2 diabetes, and obesity. The "Community Champions" group receives problem-solving training, exercise sessions, and support from community health workers. The "Homegrown Heroes" group receives a gym membership and educational newsletters on managing diabetes and heart health. The trial seeks participants in Baltimore City or Hagerstown with low income and early signs of heart issues. Those interested in becoming active with community support may find this trial a good fit. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance community health programs.

Do I need to stop my current medications for 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that social support and community involvement can greatly enhance health and well-being. This principle is central to the "Community Champions" program. One study found that working with community health workers and attending group support sessions helps people manage their health more effectively. This approach poses no major safety concerns, as it emphasizes behavior change and support rather than medication.

In the "Homegrown Heroes" group, participants receive a YMCA membership and educational newsletters. Exercise and health management education are generally safe and offer well-known benefits. These low-risk activities aim to promote a healthy lifestyle.

Both programs emphasize support and education, which are generally safe methods to improve health. No serious problems have been reported with these activities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these programs for heart failure because they focus on community-based support and behavioral changes rather than just medication. The "Community Champions" intervention is unique because it includes bi-weekly problem-solving training sessions with groups and support from community health workers, along with a YMCA membership for guided exercise, promoting a holistic approach to health. Meanwhile, the "Homegrown Heroes" program offers educational newsletters on diabetes self-management and heart health, alongside a YMCA membership, making it an accessible option for lifestyle improvement. Both programs emphasize empowering individuals to manage their health actively, which could lead to better long-term outcomes than relying solely on standard medical treatments.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that community programs, such as "Community Champions," one of the treatment arms in this trial, can lead to small but meaningful improvements in heart health. For example, a study found that participants working with community health workers experienced a slight decrease in heart disease risk. This indicates that regular support and guidance can help individuals better care for their heart.

Similarly, "Homegrown Heroes," another treatment arm in this trial, focuses on education and self-care. Studies have shown that this approach reduces hospital visits for heart failure by almost 12%. This underscores the importance of learning about and managing one's own health to prevent problems.

Both strategies in this trial demonstrate the benefits of community support and education in improving heart health, particularly for individuals with conditions like diabetes and obesity. ^{5 6 7 8 9}

Who Is on the Research Team?

Chiadi Ndumele, MD, PhD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults with low socioeconomic status, obesity (BMI≥30), type 2 diabetes, and early signs of heart failure in Baltimore City or Hagerstown. Participants must have evidence of cardiac dysfunction and be from specific medical centers in Maryland.

Inclusion Criteria

My BMI is 30 or higher.

I have heart issues shown by tests.

I have type 2 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-month multilevel intervention involving problem-solving training, exercise training, and support from community health workers

6 months

Bi-weekly problem-solving sessions, monthly community health worker visits

Follow-up

Participants are monitored for changes in health outcomes such as hemoglobin A1c, cardiac biomarkers, and self-care measures

6 months

Follow-up assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Community Champions
• Homegrown Heroes

Trial Overview

The study tests a 6-month intervention combining problem-solving training, exercise support by community health workers against just education and access to a community exercise facility. It aims to improve outcomes for those with diabetes at risk of heart failure.

How Is the Trial Designed?

Group I: Community Champions Experimental Treatment 1 Intervention

Participants assigned to the "Community Champions" group will undergo a six-month behavioral intervention. This intervention involves bi-weekly problem-solving training sessions (DECIDE) conducted in groups of 6-10 individuals, along with support from community health workers. Additionally, participants will receive a YMCA membership to exercise with a professional health coach.

Group II: Homegrown Heroes Active Control 1 Intervention

Participants assigned to the "Homegrown Heroes" will receive a YMCA membership for exercise and a monthly newsletters for 6 months that include education about diabetes self-management, healthy lifestyle and heart failure prevention .

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Patients with heart failure reported positive perceptions of the care received from the innovative community-based service (CH-CSSS-CSHFP), highlighting the importance of staying home and receiving health-related monitoring.

The study identified key themes such as the desire for connection to the healthcare system, which can inform healthcare professionals in designing more effective services for managing heart failure in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A "basket of care" for heart failure patients managing at home: evaluating a community-based nursing intervention from a patient's perspective. Young, B., Purden, M., Sauvé, N., et al.[2008]

Patient-reported outcomes (PROs) are essential for capturing the real-life impact of heart failure on patients, including their symptoms and quality of life, but are not routinely included in clinical trials.

To improve the relevance of PROs in heart failure research and patient care, there is a need for standardized measures and methods for data collection and analysis, as well as further research to establish clinically important thresholds for these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures and patient engagement in heart failure clinical trials: multi-stakeholder perspectives. Zannad, F., Alikhaani, J., Alikhaani, S., et al.[2023]

A randomized controlled trial involving 9 trained mentors showed that peer support significantly improved heart failure self-care among patients over a 3-month period (P < .05).

Despite the positive impact on self-care, the intervention group experienced a 96% higher heart failure readmission rate compared to the control group, indicating that while peer support can help with self-management, it may not reduce hospitalizations without additional professional education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is individual peer support a promising intervention for persons with heart failure? Riegel, B., Carlson, B.[2019]

Heart failure is a significant health issue in Canada, affecting over 500,000 people, with a high five-year mortality rate of 45%, highlighting the urgent need for effective management strategies.

Disease management programs for heart failure patients have been shown to improve outcomes, reduce hospitalizations, and lower costs, yet there is a lack of national benchmarks for timely access to necessary cardiovascular care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating the right patient at the right time: access to heart failure care. Ross, H., Howlett, J., Arnold, JM., et al.[2022]

Heart failure (HF) is a significant global health issue with poor outcomes, partly due to the lack of understanding and treatment for specific HF sub-types.

Registry-based randomized clinical trials, like those from the Swedish Heart Failure Registry, offer a practical and cost-effective way to improve HF research and patient care, addressing unmet needs in treatment implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure registries - Future directions. Pol, T., Karlström, P., Lund, LH.[2023]

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]

A 12-week telehealth program significantly improved heart failure symptoms and adherence to treatment in 425 discharged patients, indicating its effectiveness in managing heart failure post-discharge.

The program also enhanced patients' self-care skills and mental health, suggesting that telehealth can play a crucial role in supporting heart failure patients and reducing hospital readmissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telehealth program benefits discharged patients with heart failure. Cao, G., Fan, C., Liu, Y., et al.[2023]

Chronic heart failure (CHF) is most prevalent in areas with older populations and higher Indigenous populations, yet there is a significant lack of CHF management programs in rural regions, with only 4 programs outside major cities serving a small number of patients.

Patients with CHF face considerable distances to access management programs, averaging 332 km to the nearest program, highlighting a major inequity in healthcare access for rural Australians compared to urban areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inequitable provision of optimal services for patients with chronic heart failure: a national geo-mapping study. Clark, RA., Driscoll, A., Nottage, J., et al.[2020]

The Heart Failure Collaboratory developed a streamlined case report form (CRF) for heart failure clinical trials, reducing the number of data items from 176 to 75 baseline items and 6 events, which aims to improve trial efficiency and reduce administrative burdens.

This new consensus CRF, created with input from various stakeholders including patients and the FDA, is designed to enhance data compatibility across trials, ultimately improving the integrity of evidence collected in heart failure device development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a "Lean" Case Report Form for Heart Failure Therapeutic Development. Psotka, MA., Fiuzat, M., Carson, PE., et al.[2020]

A program designed to teach heart failure patients effective self-management has expanded its reach from 40 to 100 patients, indicating its growing success and importance in healthcare.

This initiative addresses the financial strain on hospitals caused by heart failure admissions, highlighting the need for effective patient education to improve outcomes and reduce costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth helps hospital cut readmissions by 75%. [2019]

Enrolling patients in nurse-led disease management programs after hospitalization for heart failure significantly reduces the likelihood of re-admissions within 30 and 90 days, highlighting the importance of post-discharge care.

Factors such as living alone, cognitive impairment, and depression were linked to higher risks of re-admission and death, indicating that addressing these issues may further improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of post-discharge management on rates of early re-admission and death after hospitalisation for heart failure. Huynh, Q., Negishi, K., De Pasquale, C., et al.[2020]

An open access heart failure service effectively diagnosed and managed chronic heart failure in 963 patients over eight years, with only 30.8% diagnosed with left ventricular systolic dysfunction (LVSD).

Key predictors of LVSD included male gender, age over 60, diabetes, ischaemic heart disease, atrial fibrillation, abnormal ECG, and a cardiothoracic ratio greater than 0.5, suggesting that these factors can help identify at-risk patients in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chronic heart failure in the community: role of a hospital based open access heart failure service. Shah, S., Davies, MK., Cartwright, D., et al.[2018]

A systematic review of 33 studies involving 3355 participants identified key mechanisms in heart failure management programs, highlighting the importance of increasing patient understanding of heart failure and self-care practices.

Effective heart failure programs should focus on enhancing patient self-efficacy, involving caregivers, and improving psychosocial well-being, rather than just copying existing program components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the main mechanisms of heart failure disease management interventions. Clark, AM., Wiens, KS., Banner, D., et al.[2022]

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