Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure (NCT06115369) | Clinical Trial Compass
CompletedNot Applicable
Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure
United States150 participantsStarted 2024-04-15
Plain-language summary
The current study proposes to investigate if the provision of healthy food can improve outcomes following discharge after HF hospitalization. To investigate this in an efficient and pragmatic manner, a factorial randomized control trial design will be utilized to simultaneously investigate two separate, important food-related questions:
* Does the provision of 90 days of either medically-tailored meals or fresh produce boxes improve 90-day patient outcomes among those with HF relative to a control group not receiving food supplements and instead receiving an equivalent monetary supplement?
* Does receipt of the supplement in a conditional fashion, where the supplement is continued only if the participant attends follow-up visits or fills prescribed medications at the pharmacy, have more impact than providing unconditional supplementation?
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults over 18 years age with a recent hospitalization for acute decompensated HF
Exclusion Criteria:
* Baseline hyperkalemia with K \> 5.5 mEq/L or history of hyperkalemia requiring hospitalization for urgent treatment,
* Receipt of a heart transplant or left ventricular assist device,
* Use of inotropic therapy at hospital discharge,
* Discharge to a skilled nursing facility or long-term care facility that provides prepared patient meals, comorbidity with expected survival \< 6 months, and
* Inability to provide an address to receive produce shipments (including unhoused individuals or individuals residing in temporary housing shelters).
* Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with a readmission or emergency department visit for HF
Timeframe: 90 days
Trial details
NCT IDNCT06115369
SponsorUniversity of Texas Southwestern Medical Center