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Completed

NCT Number: NCT05928026

Financial Support in an Underserved and Low-Income Population With Heart Failure

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.

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Key information

Conditions

Heart Failure, Systolic Behavior Behavioral Symptoms Cardiovascular Diseases Financial Stress Health Behavior Heart Diseases Heart Failure Medication Adherence Patient Acceptance of Health Care Patient Compliance Quality of Life Stress, Psychological Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Financial Support

Behavioral

A debit card will be loaded with $500 and can be used like a typical debit card.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. Appointment Completion Rate

    Time frame: 1 Month

    This outcome will be captured through review of the electronic medical records

  8. Appointment Completion Rate

    Time frame: 2 months

    This outcome will be captured through review of the electronic medical records

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: FUND-HF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2023
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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