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.
Conditions:
🦠 Heart Failure, Systolic 🦠 Financial Stress 🦠 Medication Adherence 🦠 Quality of Life
🗓️ Study Start (Actual) 9 June 2023
🗓️ Primary Completion (Estimated) 1 July 2024
✅ Study Completion (Estimated) 1 December 2024
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Dallas, Texas, United States

📋 Eligibility Criteria

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.
Ages Eligible for Study: 18 Years to 80 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 5 June 2023
  • First Submitted that Met QC Criteria 28 June 2023
  • First Posted 3 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 April 2024
  • Last Update Posted 19 April 2024
  • Last Verified April 2024