Financial Support in an Underserved and Low-Income Population With Heart Failure (FUND-HF)

July 5, 2025 updated by: Ambarish Pandey, University of Texas Southwestern Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age > 18
  • English speaking participants who completed SOCIAL-HF study surveys
  • Ejection Fraction <=40% and eligible for at least one component of GDMT
  • Has at least some difficulty paying monthly bills (Somewhat Difficult and Very Difficult)
  • Annual household income <130% Federal Poverty Limit

  • Have at least two additional social needs based on the following domains:

    • Cost-related nonadherence
    • Food Insecurity
    • Housing Instability
    • Transportation Difficulty
    • Unemployment
    • Household Crowding: Person/Room Ratio >1
    • Rent Burden: Rent/Income Ratio >30%
    • Low social support
    • Interpersonal Violence
    • History of Discrimination

Exclusion Criteria:

  • Unwilling to return for 1 and 2-month follow-up visits.
  • Currently in jail or prison
  • Primary residence outside Dallas County
  • Legal Blindness
  • Systolic blood pressure <90 mmHg on screening
  • Contraindications or Intolerance all medications available for therapeutic drug monitoring (metoprolol, losartan, lisinopril, valsartan, and spironolactone)
  • Unable to answer orientation questions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Financial Support
This group will receive $500 at the completion of their baseline visit
Behavioral: Financial Support
A debit card will be loaded with $500 and can be used like a typical debit card.
Active Comparator: Delayed Financial Support
This group will receive no financial support at their completion of their baseline visit, but will receive $500 at their 1-month visit.
Behavioral: Financial Support
A debit card will be loaded with $500 and can be used like a typical debit card.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 1 month
Quality of life will be ascertained using the KCCQ-12, a validated measure of quality of life among patients with heart failure. The score contains four domains, physical limitation, symptom frequency, quality of life, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 denoting the best possible health. These scores are averaged and presented as a summary score.
1 month
Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 2 months
Quality of life will be ascertained using the KCCQ-12, a validated measure of quality of life among patients with heart failure. The score contains four domains, physical limitation, symptom frequency, quality of life, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 denoting the best possible health. These scores are averaged and presented as a summary score.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported medication adherence by Morisky Medication Adherence Scale
Time Frame: 1 month
Self-reported medication adherence will be captured by the Morisky Medication Adherence Scale. This scale is an eight-item survey. The score ranges from 0-8, with higher scores denoting greater adherence.
1 month
Self-reported medication adherence by Morisky Medication Adherence Scale
Time Frame: 2 months
Self-reported medication adherence will be captured by the Morisky Medication Adherence Scale. This scale is an eight-item survey. The score ranges from 0-8, with higher scores denoting greater adherence.
2 months
Change in social stress
Time Frame: 1 months
This will be captured using the perceived stress scale. This is a ten-item survey assessing perceived stress over the last month. The scores range from 0-40, with higher scores denoting higher perceived stress.
1 months
Change in social stress
Time Frame: 2 months
This will be captured using the perceived stress scale. This is a ten-item survey assessing perceived stress over the last month. The scores range from 0-40, with higher scores denoting higher perceived stress.
2 months
Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)
Time Frame: 1 month
This will be ascertained using serum therapeutic drug monitoring of guideline-directed medical therapies.
1 month
Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)
Time Frame: 2 months
This will be ascertained using serum therapeutic drug monitoring of guideline directed medical therapies.
2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychologic Stress by Kessler Screening Scale
Time Frame: 1 Month
This is a ten-item instrument measuring psychological distress. Each item has a five-level response scale. The range is 10-50, with higher scores denoting greater psychological distress.
1 Month
Psychologic Stress by Kessler Screening Scale
Time Frame: 2 months
This is a ten-item instrument measuring psychological distress. Each item has a five-level response scale. The range is 10-50, with higher scores denoting greater psychological distress.
2 months
Number of Emergency Room Visits
Time Frame: 1 Month
This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium
1 Month
Number of Emergency Room Visits
Time Frame: 2 Month
This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium
2 Month
Number of Hospitalizations
Time Frame: 1 Month
This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium
1 Month
Number of Hospitalizations
Time Frame: 2 months
This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium
2 months
Appointment Completion Rate
Time Frame: 1 Month
This outcome will be captured through review of the electronic medical records
1 Month
Appointment Completion Rate
Time Frame: 2 months
This outcome will be captured through review of the electronic medical records
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Ambarish Pandey, MD,MSCS, UT Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2023

Primary Completion (Actual)

April 11, 2025

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

June 5, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 5, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2022-1033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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