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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05928026
Collaborator
(none)
120
Enrollment
1
Location
2
Arms
16.8
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Financial Support
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Financial Support in an Underserved and Low-Income Population With Heart Failure
Anticipated Study Start Date :
Jul 9, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Immediate Financial Support

This group will receive $500 at the completion of their baseline visit

Behavioral: Financial Support
A debit card will be loaded with $500 and can be used like a typical debit card.
Active Comparator: Delayed 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.

Behavioral: Financial Support
A debit card will be loaded with $500 and can be used like a typical debit card.

Outcome Measures

Primary Outcome Measures

  1. Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT) [1 month]

    The first co-primary outcome will be a medication adherence outcome. This will be ascertained using serum therapeutic drug monitoring of guideline directed medical therapies.

  2. Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT) [2 months]

    The first co-primary outcome will be a medication adherence outcome. This will be ascertained using serum therapeutic drug monitoring of guideline directed medical therapies.

  3. Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ) [1 month]

    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.

  4. 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

  1. Self-reported medication adherence by Morisky Medication Adherence Scale [1 month]

    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.

  2. 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.

  3. Change in social stress [1 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.

  4. 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.

Other Outcome Measures

  1. Psychologic Stress by Kessler Screening Scale [1 Month]

    This is a ten-item instrument measuring psychological distress. Each item has a five-level response scale. The range is 10-50, with higher scores denoting greater psychological distress.

  2. Psychologic Stress by Kessler Screening Scale [2 months]

    This is a ten-item instrument measuring psychological distress. Each item has a five-level response scale. The range is 10-50, with higher scores denoting greater psychological distress.

  3. Number of Emergency Room Visits [1 Month]

    This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium

  4. Number of Emergency Room Visits [2 Month]

    This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium

  5. Number of Hospitalizations [1 Month]

    This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium

  6. Number of Hospitalizations [2 months]

    This outcome will be captured through review of the electronic medical record and adjudicated using the DFW Hospital Consortium

  7. Appointment Completion Rate [1 Month]

    This outcome will be captured through review of the electronic medical records

  8. Appointment Completion Rate [2 months]

    This outcome will be captured through review of the electronic medical records

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 UT Southwestern Medical Center Dallas Texas United States 75235

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Ambarish Pandey, MD,MSCS, UT Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ambarish Pandey, Assistant Professor of Internal Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT05928026
Other Study ID Numbers:
  • STU-2022-1033
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 3, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ambarish Pandey, Assistant Professor of Internal Medicine, University of Texas Southwestern Medical Center
social determinants of health
Additional relevant MeSH terms:
Heart Failure
Heart Failure, Systolic
Financial Stress

Study Results

No Results Posted as of Jul 3, 2023