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NCT05928026 | RECRUITING | Heart Failure, Systolic

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

University of Texas Southwestern Medical Center

Information provided by (Responsible Party):

Ambrish Pandey

Brief Summary:

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.

Condition or disease

Heart Failure, Systolic

Financial Stress

Medication Adherence

Quality of Life

Intervention/treatment

Financial Support

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Financial Support in an Underserved and Low-Income Population With Heart Failure
Actual Study Start Date : 2023-06-09
Estimated Primary Completion Date : 2024-10-01
Estimated Study Completion Date : 2024-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Financial Support in an Underserved and Low-Income Population With Heart Failure

Location Details

NCT05928026

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Locations

RECRUITING

United States, Texas

UT Southwestern Medical Center

dallas, Texas, United States, 75235