Financial Support for Heart Failure

(FUND-HF Trial)

Overseen By Ambarish Pandey, MD, MSCS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Jail, Outside Dallas, Legal blindness, others

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: 3

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test whether financial support in the form of a one-time $500 stipend would improve medication adherence and quality of life in low-income, socially-needy patients with heart failure with reduced ejection fraction in the post-discharge setting. The main questions it aims to answer are: * Will financial support improve heart failure quality of life? * Will financial support improve medication adherence? Participants will complete surveys on quality of life, social stress, and spending habits at their baseline visit. Participants will be randomly assigned to receive $500 at their baseline visit or $0 at their baseline visit. At their one month visit, quality of life and medication adherence will be assessed. These results will be compared between groups. The group that received $0 at their baseline visit will be provided $500 at their one-month visit and return for a two-month visit. At that visit, quality of life and medication adherence will be assessed. These results will be compared to their one-month results. Researchers will compare the 1-month quality of life scores and medication adherence scores between the immediate financial support vs delayed financial support. Researchers will also compare 1-month vs 2-month quality of life and adherence data for participants who were randomized to the delayed financial support group.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It focuses on financial support to improve medication adherence, so it's likely you will continue your current medications.

What data supports the effectiveness of the treatment Financial Support, Food Vouchers, Cash Assistance, Nutritional Support for heart failure?

Research shows that education and support programs for heart failure patients can improve outcomes, reduce hospital readmissions, and lower costs. These programs often involve patient education and support, which are considered effective non-drug therapies for managing heart failure. ^{1 2 3 4 5}

Is financial support for heart failure safe for humans?

The studies reviewed do not report any safety concerns related to financial support programs like food vouchers or cash assistance for various conditions, suggesting they are generally safe for humans. ^{6 7 8 9 10}

How does the treatment in the Financial Support for Heart Failure trial differ from other treatments for heart failure?

The treatment in this trial is unique because it focuses on providing financial support, such as food vouchers, to improve dietary habits and health outcomes, rather than using traditional medical interventions. This approach aims to address financial barriers to healthy eating, which can indirectly benefit heart health. ^{6 8 11 12 13}

Research Team

Ambarish Pandey, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for adults over 18 with heart failure and reduced ejection fraction, living on a low income (below 130% of the Federal Poverty Limit), who have trouble paying bills and at least two other social challenges like food or housing issues. They must be English-speaking, from Dallas County, not in jail/prison, able to see well enough to participate, and willing to return for follow-up visits.

Inclusion Criteria

I face at least two challenges like trouble affording care, not enough food, unstable housing, transportation issues, joblessness, crowded living conditions, high rent burden, lack of support, experiencing violence or discrimination.

My heart's pumping ability is reduced, but I can receive some standard heart treatments.

I struggle to pay my monthly bills.

Exclusion Criteria

I am not willing to return for follow-up visits 1 and 2 months after treatment.

You live outside of Dallas County.

I struggle to answer basic questions about where I am or what time it is.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Visit

Participants complete surveys on quality of life, social stress, and spending habits. Random assignment to receive $500 or $0.

1 day

1 visit (in-person)

1-Month Follow-up

Quality of life and medication adherence are assessed. Participants in the delayed financial support group receive $500.

1 month

1 visit (in-person)

2-Month Follow-up

Quality of life and medication adherence are assessed for the delayed financial support group.

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention period.

2 months

Treatment Details

Interventions

• Financial Support

Trial Overview Researchers are testing if giving $500 can help patients with heart failure stick to their medication plans better and improve their quality of life. Half will get money right away; the other half later. Their medication use and life quality are checked after one month then again after two months for those who got money later.

Participant Groups

Group I: Immediate Financial Support Experimental Treatment 1 Intervention

This group will receive $500 at the completion of their baseline visit

Group II: Delayed Financial Support Active Control 1 Intervention

This group will receive no financial support at their completion of their baseline visit, but will receive $500 at their 1-month visit.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Findings from Research

A telephone support program for heart transplant patients significantly improved communication with healthcare providers, with 28 calls made over approximately 194 days, addressing medication adjustments and lifestyle issues.

This program helped enhance medication compliance and early detection of complications, potentially reducing unnecessary hospital visits and improving overall patient management post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support program for heart transplant patients: initial experience. Moro, JA., Almenar, L., Martńez-Dolz, L., et al.[2008]

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]

Multidisciplinary care programs for chronic heart failure, which include specialized teams and dedicated nurses, have been shown to improve patient outcomes by reducing hospital readmissions and enhancing the quality and cost-effectiveness of care.

Patient education and support interventions, even without direct medical management, have proven effective in lowering readmissions and in-hospital costs, suggesting that these strategies should be recognized as important non-pharmacological therapies for heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Educating and communicating: non-pharmacologic treatment for patients with chronic heart failure?]. De Feo, S., Opasich, C.[2016]

The Center for Medicare and Medicaid Services (CMS) is actively working to enhance care for Medicare beneficiaries with heart failure through quality improvement initiatives, including the National Heart Failure project.

Data collected from the National Heart Failure project is crucial for guiding and evaluating quality improvement efforts in hospitals, focusing on key indicators like ejection fraction documentation and the prescription of angiotensin-converting enzyme inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from the national heart failure project: a center for medicare and medicaid services initiative to improve the care of medicare beneficiaries with heart failure. Havranek, EP., Masoudi, FA., Smith, GL., et al.[2019]

In a study of 230 heart failure patients, standard information provided before hospital discharge did not significantly differ in effectiveness from additional education using an interactive CD-ROM, with 52% of the standard group and 49% of the education group reaching the endpoint of readmission or death within 6 months.

Patients who received the interactive education showed improved knowledge about heart failure, suggesting that while the education did not significantly reduce readmission rates, better understanding of the condition may lead to marginally better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an interactive CD-program on 6 months readmission rate in patients with heart failure - a randomised, controlled trial [NCT00311194]. Linné, AB., Liedholm, H.[2018]

In a study involving 33 cancer patients receiving food vouchers, participants spent 50% of their funds on healthy items like animal protein, fruits, and vegetables, indicating a positive shift in their food purchasing behaviors.

The supplemental food voucher program led to patients purchasing more healthy foods than national averages, particularly among those born outside the U.S. or with limited English proficiency, highlighting the program's potential effectiveness in improving dietary choices for food insecure cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food Purchasing Behavior of Food Insecure Cancer Patients Receiving Supplemental Food Vouchers. Paolantonio, L., Kim, SY., Ramirez, J., et al.[2023]

The NOSH study, involving interviews with 38 women and 53 healthcare providers, found that both groups preferred shopping vouchers over cash incentives for breastfeeding support, with a suggested total incentive amount of £200-250.

Concerns were raised about the potential negative impact of requiring proof of breastfeeding on women's relationships with healthcare providers, leading to a preferred method where women simply sign a statement co-signed by a healthcare professional to confirm breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encouraging breastfeeding: financial incentives. Whitford, H., Whelan, B., van Cleemput, P., et al.[2022]

The Fruit and Vegetable Prescription (FVRx) program significantly increased the consumption of dark green vegetables among participants compared to those in the Ad hoc Nutrition Education and Control groups, indicating its effectiveness in promoting healthier eating habits.

Participants in the FVRx program also showed improved food purchasing practices and financial management, suggesting that combining nutrition education with produce prescriptions can enhance food security and resource management for low-income adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. Slagel, N., Newman, T., Sanville, L., et al.[2022]

A systematic review of 10 studies on food provision programs for patients with type 2 diabetes or prediabetes showed that those including nutrition education consistently reduced HbA1c levels, indicating improved diabetes management.

Programs varied widely in their design and implementation, but those that incorporated nutrition education—covering topics like general nutrition and fruit/vegetable consumption—tended to yield better dietary quality and health outcomes compared to those without such education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. Schier, HE., Chetty, KS., Garrity, K., et al.[2023]

A study involving 50 participants with food insecurity showed that using a prefilled, nutritionally balanced online grocery shopping cart led to significantly healthier purchases compared to just reviewing nutrition information.

Participants using the default shopping cart bought more whole grains, fruits, and vegetables, while also selecting foods lower in sodium, cholesterol, and unhealthy fats, indicating that this approach can effectively promote better nutrition in financially constrained individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity. Coffino, JA., Udo, T., Hormes, JM.[2021]

A pilot study involving 66 vulnerable individuals showed that a 10-week nutrition education program, combined with food vouchers, led to higher adherence to the Mediterranean Diet and improved health parameters like weight status and lipid levels.

Despite initial improvements in the intervention group, the benefits diminished after the education program ended, highlighting that simply providing food vouchers is not enough; ongoing nutrition education is essential for sustained healthy eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Food Vouchers and an Educational Intervention on Promoting Healthy Eating in Vulnerable Families: A Pilot Study. Miguel-Berges, ML., Jimeno-Martínez, A., Larruy-García, A., et al.[2022]

A survey of physician directors of nutrition support services revealed current billing practices and reimbursement challenges related to nutrition support, highlighting the need for better understanding among practitioners.

The study aimed to provide insights into how different practices and institutions approach billing for nutrition support services, which could help improve financial management in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition support billing practices: results of a nationwide survey and responses from the Health Care Financing Administration. Flancbaum, L., Burge, JC., Choban, PS.[2019]

In Singapore, while there are funding options like MediSave and MediShield Life for nutritional support, these may not be adequate for patients requiring long-term care, highlighting a gap in financial resources.

There is an urgent need for improved funding mechanisms and targeted financial assistance to ensure that vulnerable populations, such as the elderly and low-income individuals, can access necessary nutritional support to prevent adverse health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of healthcare financing and reimbursement of nutritional support for patients in Singapore. Wong, A., Goh, SN., Sowa, PM., et al.[2021]

References

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

Support program for heart transplant patients: initial experience. [2008]

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

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

3. Italy pubmed.ncbi.nlm.nih.gov

[Educating and communicating: non-pharmacologic treatment for patients with chronic heart failure?]. [2016]

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

Lessons learned from the national heart failure project: a center for medicare and medicaid services initiative to improve the care of medicare beneficiaries with heart failure. [2019]

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

Effects of an interactive CD-program on 6 months readmission rate in patients with heart failure - a randomised, controlled trial [NCT00311194]. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Food Purchasing Behavior of Food Insecure Cancer Patients Receiving Supplemental Food Vouchers. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Encouraging breastfeeding: financial incentives. [2022]

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

Effects of a Fruit and Vegetable Prescription Program With Expanded Education for Low-Income Adults. [2022]

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

A narrative review of clinic-community food provision interventions aimed at improving diabetes outcomes among food-insecure adults: examining the role of nutrition education. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Food Vouchers and an Educational Intervention on Promoting Healthy Eating in Vulnerable Families: A Pilot Study. [2022]

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

Nutrition support billing practices: results of a nationwide survey and responses from the Health Care Financing Administration. [2019]

13. Ireland pubmed.ncbi.nlm.nih.gov

A narrative review of healthcare financing and reimbursement of nutritional support for patients in Singapore. [2021]