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Financial Support for Heart Failure (FUND-HF Trial)

N/A

Recruiting

Led By Ambarish Pandey, MD,MSCS

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ejection Fraction <=40% and eligible for at least one component of GDMT

Age > 18

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 month

Awards & highlights

FUND-HF Trial Summary

This trial tests if giving low-income patients $500 in financial support can help them adhere to medication and improve their quality of life.

Who is the study for?

This trial is for adults over 18 with heart failure and reduced ejection fraction, living on a low income (below 130% of the Federal Poverty Limit), who have trouble paying bills and at least two other social challenges like food or housing issues. They must be English-speaking, from Dallas County, not in jail/prison, able to see well enough to participate, and willing to return for follow-up visits.Check my eligibility

What is being tested?

Researchers are testing if giving $500 can help patients with heart failure stick to their medication plans better and improve their quality of life. Half will get money right away; the other half later. Their medication use and life quality are checked after one month then again after two months for those who got money later.See study design

What are the potential side effects?

Since this trial involves financial support rather than medical treatment, there aren't direct side effects like you'd expect from drugs or surgery. However, receiving or not receiving money could affect participants' stress levels.

FUND-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's pumping ability is reduced, but I can receive some standard heart treatments.

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I am older than 18 years.

FUND-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in social stress

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

Self-reported medication adherence by Morisky Medication Adherence Scale

Other outcome measures

Appointment Completion Rate

Number of Emergency Room Visits

Number of Hospitalizations

+1 more

FUND-HF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Immediate Financial SupportExperimental Treatment1 Intervention

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

Group II: Delayed Financial SupportActive Control1 Intervention

This group will receive no financial support at their completion of their baseline visit, but will receive $500 at their 1-month visit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Financial Support

2015

N/A

~80

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,615 Total Patients Enrolled

Ambarish Pandey, MD,MSCSPrincipal InvestigatorUT Southwestern Medical Center

Media Library

Immediate Financial Support Clinical Trial Eligibility Overview. Trial Name: NCT05928026 — N/A

Financial Toxicity Research Study Groups: Delayed Financial Support, Immediate Financial Support

Financial Toxicity Clinical Trial 2023: Immediate Financial Support Highlights & Side Effects. Trial Name: NCT05928026 — N/A

Immediate Financial Support 2023 Treatment Timeline for Medical Study. Trial Name: NCT05928026 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this investigation welcoming individuals of more advanced age?

"This research is seeking participants who are more than 18 but not yet 80 years of age."

Answered by AI

Do I qualify for enrollment in this clinical trial?

"In order to be considered for this trial, applicants must have been diagnosed with heart failure and aged between 18-80 years old. The experiment is scheduled to include up to 120 participants in total."

Answered by AI

Are there currently any openings for participants in this research?

"As per the clinicaltrials.gov database, this trial is not currently taking on any more participants despite having been initially posted in July 9th 2023 and last revised June 28th 2023. But there are 1066 other medical studies that require patients right now."

Answered by AI