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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Behavioral: Financial Support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Financial Support<br>This group will receive $500 at the completion of their baseline visit | Behavioral: Financial Support<br>* A debit card will be loaded with $500 and can be used like a typical debit card.<br>|
| Active Comparator: Delayed Financial Support<br>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<br>* A debit card will be loaded with $500 and can be used like a typical debit card.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT) | 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. | 1 month | 
| Detection of Serum Levels of Guideline Directed Medical Therapies (GDMT) | 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 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month | 
| 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. | 2 months | 
| 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. | 1 months | 
| 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. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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social determinants of health