Financial support for low-income heart failure patients
Financial Support in an Underserved and Low-Income Population With Heart Failure
NA · University of Texas Southwestern Medical Center · NCT05928026
This study is testing if giving low-income heart failure patients a one-time $500 payment can help them stick to their medications and feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT05928026 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if a one-time financial stipend of $500 can enhance medication adherence and improve quality of life for low-income patients with heart failure and reduced ejection fraction. Participants will be randomly assigned to receive either the stipend or no financial support at the start, and their quality of life and medication adherence will be assessed after one month. Those who initially receive no stipend will be given the financial support at the one-month mark and will return for a follow-up assessment at two months. The study focuses on the impact of financial stress on health outcomes in an underserved population.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults over 18 with heart failure, reduced ejection fraction, and significant financial stress.
Not a fit: Patients who are currently incarcerated or have legal blindness may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life and medication adherence for low-income heart failure patients.
How similar studies have performed: While financial support interventions are relatively novel in this context, similar studies have shown promise in improving health outcomes through addressing social determinants of health.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Ambarish Pandey, MD,MSCS — UT Southwestern Medical Center
- Study coordinator: Ambarish Pandey, MD, MSCS
- Email: ambarish.pandey@utsouthwestern.edu
- Phone: 214-645-9762
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Systolic, Financial Stress, Medication Adherence, Quality of Life, social determinants of health