Financial Support in an Underserved and Low-Income Population With Heart Failure
- Conditions
- Medication AdherenceHeart Failure, SystolicQuality of LifeFinancial Stress
- Interventions
- Behavioral: Financial Support
- Registration Number
- NCT05928026
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
-
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Delayed Financial Support Financial Support This group will receive no financial support at their completion of their baseline visit, but will receive $500 at their 1-month visit. Immediate Financial Support Financial Support This group will receive $500 at the completion of their baseline visit
- Primary Outcome Measures
Name Time Method Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ) 2 months Quality of life will be ascertained using the KCCQ-12, a validated measure of quality of life among patients with heart failure. The score contains four domains, physical limitation, symptom frequency, quality of life, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 denoting the best possible health. These scores are averaged and presented as a summary score.
- Secondary Outcome Measures
Name Time Method Self-reported medication adherence by Morisky Medication Adherence Scale 2 months Self-reported medication adherence will be captured by the Morisky Medication Adherence Scale. This scale is an eight-item survey. The score ranges from 0-8, with higher scores denoting greater adherence.
Change in social stress 2 months This will be captured using the perceived stress scale. This is a ten-item survey assessing perceived stress over the last month. The scores range from 0-40, with higher scores denoting higher perceived stress.
Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT) 2 months This will be ascertained using serum therapeutic drug monitoring of guideline directed medical therapies.
Trial Locations
- Locations (1)
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States