COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-09
Study Completion:2025-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05928026

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18
  2. * English speaking participants who completed SOCIAL-HF study surveys
  3. * Ejection Fraction \<=40% and eligible for at least one component of GDMT
  4. * Has at least some difficulty paying monthly bills (Somewhat Difficult and Very Difficult)
  5. * Annual household income \<130% Federal Poverty Limit
  6. * Have at least two additional social needs based on the following domains:
  7. * Cost-related nonadherence
  8. * Food Insecurity
  9. * Housing Instability
  10. * Transportation Difficulty
  11. * Unemployment
  12. * Household Crowding: Person/Room Ratio \>1
  13. * Rent Burden: Rent/Income Ratio \>30%
  14. * Low social support
  15. * Interpersonal Violence
  16. * History of Discrimination
  1. * Unwilling to return for 1 and 2-month follow-up visits.
  2. * Currently in jail or prison
  3. * Primary residence outside Dallas County
  4. * Legal Blindness
  5. * Systolic blood pressure \<90 mmHg on screening
  6. * Contraindications or Intolerance all medications available for therapeutic drug monitoring (metoprolol, losartan, lisinopril, valsartan, and spironolactone)
  7. * Unable to answer orientation questions.

Contacts and Locations

Principal Investigator

Ambarish Pandey, MD,MSCS
PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Ambarish Pandey, MD,MSCS, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-09
Study Completion Date2025-05-01

Study Record Updates

Study Start Date2023-06-09
Study Completion Date2025-05-01

Terms related to this study

Keywords Provided by Researchers

  • social determinants of health

Additional Relevant MeSH Terms

  • Heart Failure, Systolic
  • Financial Stress
  • Medication Adherence
  • Quality of Life