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

The University of Texas System (UT)

Status: Completed

Conditions: Medication Adherence; Heart Failure, Systolic; Financial Stress; Quality of Life

Treatments: Behavioral: Financial Support

Study type: Interventional

Funder types: Other

Identifiers

NCT05928026

STU-2022-1033

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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153 participants in 2 patient groups

Immediate Financial Support

Experimental group

Description:

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

Treatment:

Behavioral: Financial Support

Delayed Financial Support

Active Comparator group

Description:

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

Treatment:

Behavioral: Financial Support