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Heart Failure, SystolicFUND-HFNCT05928026

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

A study testing Financial Support in people with Heart Failure, Systolic and Financial Stress, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Financial Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
153 participants
Where
1 siteUnited States
Study dates
9 Jun 2023to 1 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 16Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UT Southwestern Medical Center

    Dallas, Texas, 75235

Other trials in United States

About this study

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?
Read more

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.

Being tested
Financial Support
Keywords
social determinants of health
Medical subject headings
Heart Failure, Systolic, Financial Stress, Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Financial SupportBehavioural

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

Study groups in NCT05928026
Study groupRoleWhat they receive
Immediate Financial SupportExperimentalThis group will receive $500 at the completion of their baseline visit
Receives: Behavioral: Financial Support
Delayed Financial SupportActive comparatorThis group will receive no financial support at their completion of their baseline visit, but will receive $500 at their 1-month visit.
Receives: Behavioral: Financial Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    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.

    Measured: 1 month

  2. Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ)

    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.

    Measured: 2 months

Secondary outcomes (6)

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

    This will be ascertained using serum therapeutic drug monitoring of guideline-directed medical therapies.

    Measured: 1 month

  2. Self-reported medication adherence by Morisky Medication Adherence Scale

    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.

    Measured: 1 month

  3. Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)

    This will be ascertained using serum therapeutic drug monitoring of guideline directed medical therapies.

    Measured: 2 months

  4. Self-reported medication adherence by Morisky Medication Adherence Scale

    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.

    Measured: 2 months

  5. Change in social stress

    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.

    Measured: 1 months

  6. Change in social stress

    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.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start9 Jun 2023
  3. Primary completion11 Apr 2025
  4. Study completion1 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05928026
Sponsor's protocol ID
STU-2022-1033
Acronym
FUND-HF
Status last verified
Jul 2025
First submitted
5 Jun 2023
Last updated
8 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heidenreich PA, Albert NM, Allen LA, Bluemke DA, Butler J, Fonarow GC, Ikonomidis JS, Khavjou O, Konstam MA, Maddox TM, Nichol G, Pham M, Pina IL, Trogdon JG; American Heart Association Advocacy Coordinating Committee; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Stroke Council. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013 May;6(3):606-19. doi: 10.1161/HHF.0b013e318291329a. Epub 2013 Apr 24.

    PubMed 23616602

  • Greene SJ, Butler J, Albert NM, DeVore AD, Sharma PP, Duffy CI, Hill CL, McCague K, Mi X, Patterson JH, Spertus JA, Thomas L, Williams FB, Hernandez AF, Fonarow GC. Medical Therapy for Heart Failure With Reduced Ejection Fraction: The CHAMP-HF Registry. J Am Coll Cardiol. 2018 Jul 24;72(4):351-366. doi: 10.1016/j.jacc.2018.04.070.

    PubMed 30025570

  • Hood SR, Giazzon AJ, Seamon G, Lane KA, Wang J, Eckert GJ, Tu W, Murray MD. Association Between Medication Adherence and the Outcomes of Heart Failure. Pharmacotherapy. 2018 May;38(5):539-545. doi: 10.1002/phar.2107. Epub 2018 Apr 30.

    PubMed 29600819

  • Wu JR, Moser DK, De Jong MJ, Rayens MK, Chung ML, Riegel B, Lennie TA. Defining an evidence-based cutpoint for medication adherence in heart failure. Am Heart J. 2009 Feb;157(2):285-91. doi: 10.1016/j.ahj.2008.10.001. Epub 2008 Dec 24.

    PubMed 19185635

  • Riegel B, Lee CS, Ratcliffe SJ, De Geest S, Potashnik S, Patey M, Sayers SL, Goldberg LR, Weintraub WS. Predictors of objectively measured medication nonadherence in adults with heart failure. Circ Heart Fail. 2012 Jul 1;5(4):430-6. doi: 10.1161/CIRCHEARTFAILURE.111.965152. Epub 2012 May 30.

    PubMed 22647773

  • Henderson KH, Helmkamp LJ, Steiner JF, Havranek EP, Vupputuri SX, Hanratty R, Blair IV, Maertens JA, Dickinson M, Daugherty SL. Relationship Between Social Vulnerability Indicators and Trial Participant Attrition: Findings From the HYVALUE Trial. Circ Cardiovasc Qual Outcomes. 2022 May;15(5):e007709. doi: 10.1161/CIRCOUTCOMES.120.007709. Epub 2022 Apr 14.

    PubMed 35418247

  • Akwo EA, Kabagambe EK, Harrell FE Jr, Blot WJ, Bachmann JM, Wang TJ, Gupta DK, Lipworth L. Neighborhood Deprivation Predicts Heart Failure Risk in a Low-Income Population of Blacks and Whites in the Southeastern United States. Circ Cardiovasc Qual Outcomes. 2018 Jan;11(1):e004052. doi: 10.1161/CIRCOUTCOMES.117.004052.

    PubMed 29317456

  • Wu JR, Frazier SK, Rayens MK, Lennie TA, Chung ML, Moser DK. Medication adherence, social support, and event-free survival in patients with heart failure. Health Psychol. 2013 Jun;32(6):637-46. doi: 10.1037/a0028527. Epub 2012 Jul 2.

    PubMed 22746258

  • Wu JR, Holmes GM, DeWalt DA, Macabasco-O'Connell A, Bibbins-Domingo K, Ruo B, Baker DW, Schillinger D, Weinberger M, Broucksou KA, Erman B, Jones CD, Cene CW, Pignone M. Low literacy is associated with increased risk of hospitalization and death among individuals with heart failure. J Gen Intern Med. 2013 Sep;28(9):1174-80. doi: 10.1007/s11606-013-2394-4. Epub 2013 Mar 12.

    PubMed 23478997

  • Liao L, Allen LA, Whellan DJ. Economic burden of heart failure in the elderly. Pharmacoeconomics. 2008;26(6):447-62. doi: 10.2165/00019053-200826060-00001.

    PubMed 18489197

  • Barankay I, Reese PP, Putt ME, Russell LB, Loewenstein G, Pagnotti D, Yan J, Zhu J, McGilloway R, Brennan T, Finnerty D, Hoffer K, Chadha S, Volpp KG. Effect of Patient Financial Incentives on Statin Adherence and Lipid Control: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2019429. doi: 10.1001/jamanetworkopen.2020.19429.

    PubMed 33034639

  • Volpp KG, Loewenstein G, Troxel AB, Doshi J, Price M, Laskin M, Kimmel SE. A test of financial incentives to improve warfarin adherence. BMC Health Serv Res. 2008 Dec 23;8:272. doi: 10.1186/1472-6963-8-272.

    PubMed 19102784

  • Volpp KG, Troxel AB, Mehta SJ, Norton L, Zhu J, Lim R, Wang W, Marcus N, Terwiesch C, Caldarella K, Levin T, Relish M, Negin N, Smith-McLallen A, Snyder R, Spettell CM, Drachman B, Kolansky D, Asch DA. Effect of Electronic Reminders, Financial Incentives, and Social Support on Outcomes After Myocardial Infarction: The HeartStrong Randomized Clinical Trial. JAMA Intern Med. 2017 Aug 1;177(8):1093-1101. doi: 10.1001/jamainternmed.2017.2449.

    PubMed 28654972

Questions about this trial

What is this clinical trial studying?

A study testing Financial Support in people with Heart Failure, Systolic and Financial Stress, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Failure Quality of Life by Kansas City Cardiomyopathy Questionnaire (KCCQ) (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05928026, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.

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