NCT05928026Completed
Financial Support in an Underserved and Low-Income Population With Heart Failure
Source: ClinicalTrials.gov · Last updated 8 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 153 (actual)
- First submitted
- 5 Jun 2023
- Start date
- 9 Jun 2023
- Primary completion date
- 11 Apr 2025
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Heart failure
- NCT number
- NCT05928026
What you commit to
- Study type: Interventional
- Participants enrolled: 153
- From 9 Jun 2023 to the primary completion date, 11 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications or Intolerance all medications available for therapeutic drug monitoring (metoprolol, losartan, lisinopril, valsartan, and spironolactone)
Other
- 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
- Unable to answer orientation questions.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.