Financial Support in an Underserved and Low-Income Population With Heart Failure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure, Systolic
- Sponsor
- University of Texas Southwestern Medical Center
- Enrollment
- 153
- Locations
- 1
- Primary Endpoint
- Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
- Status
- Completed
- Last Updated
- 9 months ago
Overview
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.
Investigators
Ambarish Pandey
Assistant Professor of Internal Medicine
University of Texas Southwestern Medical Center
Eligibility 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
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.
Outcomes
Primary Outcomes
Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 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 Outcomes
- Self-reported medication adherence by Morisky Medication Adherence Scale(2 months)
- Change in social stress(2 months)
- Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)(2 months)