Heart Failure Clinical Trial

Financial Support in an Underserved and Low-Income Population With Heart Failure

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 medication adherence?
Will financial support improve heart failure quality of life?

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, medication adherence and quality of life 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, medication adherence and quality of life will be assessed. These results will be compared to their one-month results.

Researchers will compare the 1-month medication adherence and quality of life scores between the immediate financial support vs delayed financial support. Researchers will also compare 1-month vs 2-month adherence and quality of life data for participants who were randomized to the delayed financial support group.

View Eligibility Criteria

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
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.

Study is for people with:

Heart Failure

Estimated Enrollment:

120

Study ID:

NCT05928026

Recruitment Status:

Recruiting

Sponsor:

University of Texas Southwestern Medical Center

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There is 1 Location for this study

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UT Southwestern Medical Center
Dallas Texas, 75235, United States More Info
Ambarish Pandey, MD,MSCS
Contact
214-645-9762

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

120

Study ID:

NCT05928026

Recruitment Status:

Recruiting

Sponsor:


University of Texas Southwestern Medical Center

How clear is this clinincal trial information?

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