Clinical trial NCT05928026: Financial Support in an Underserved and Low-Income Population With Heart Failure
Official title: Financial Support in an Underserved and Low-Income Population With Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure, Systolic
Financial Stress
Medication Adherence
Quality of Life
Keywords: social determinants of health
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 1 month
measure: Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 2 months
Secondary outcomes:
measure: Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)
timeFrame: 1 month
measure: Self-reported medication adherence by Morisky Medication Adherence Scale
timeFrame: 1 month
measure: Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)
timeFrame: 2 months
measure: Self-reported medication adherence by Morisky Medication Adherence Scale
timeFrame: 2 months
measure: Change in social stress
timeFrame: 1 months
measure: Change in social stress
timeFrame: 2 months
Other outcomes:
measure: Psychologic Stress by Kessler Screening Scale
timeFrame: 1 Month
measure: Psychologic Stress by Kessler Screening Scale
timeFrame: 2 months
measure: Number of Emergency Room Visits
timeFrame: 1 Month
measure: Number of Emergency Room Visits
timeFrame: 2 Month
measure: Number of Hospitalizations
timeFrame: 1 Month
measure: Number of Hospitalizations
timeFrame: 2 months
measure: Appointment Completion Rate
timeFrame: 1 Month
measure: Appointment Completion Rate
timeFrame: 2 months
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Ambarish Pandey, MD,MSCS
role: PRINCIPAL_INVESTIGATOR
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