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

NCT05928026 | Completed

• 1 other identifier: STU-2022-1033
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

social determinants of health

Outcome Measures

Primary Outcomes (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.

  1 month

• 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.

  2 months

Secondary Outcomes (6)

• Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)

  1 month

• Self-reported medication adherence by Morisky Medication Adherence Scale

  1 month

• Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT)

  2 months

• Self-reported medication adherence by Morisky Medication Adherence Scale

  2 months

• Change in social stress

  1 months

Other Outcomes (8)

• Psychologic Stress by Kessler Screening Scale

  1 Month

• Psychologic Stress by Kessler Screening Scale

  2 months

• Number of Emergency Room Visits

  1 Month

Study Arms (2)

Immediate Financial Support

EXPERIMENTAL

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

Behavioral: Financial Support

Delayed Financial Support

ACTIVE COMPARATOR

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

Interventions

Financial Support BEHAVIORAL

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

Delayed Financial Support; Immediate Financial Support

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (13)

• 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.

  PMID: 23616602 BACKGROUND

• 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.

  PMID: 30025570 BACKGROUND

• 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.

  PMID: 29600819 BACKGROUND

• 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.

  PMID: 19185635 BACKGROUND

• 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.

  PMID: 22647773 BACKGROUND

• 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.

  PMID: 35418247 BACKGROUND

• 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.

  PMID: 29317456 BACKGROUND

• 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.

  PMID: 22746258 BACKGROUND

• 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.

  PMID: 23478997 BACKGROUND

• 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.

  PMID: 18489197 BACKGROUND

• 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.

  PMID: 33034639 BACKGROUND

• 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.

  PMID: 19102784 BACKGROUND

• 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.

  PMID: 28654972 BACKGROUND

MeSH Terms

Conditions

Heart Failure, Systolic; Financial Stress; Medication Adherence

Interventions

Financial Support

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Stress, Psychological; Behavioral Symptoms; Behavior; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations

Study Officials

• Ambarish Pandey, MD,MSCS

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 3, 2023
• Study Start: June 9, 2023
• Primary Completion: April 11, 2025
• Study Completion: May 1, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)