Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure
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 2x2 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?
Conditions:
🦠 Heart Failure
🗓️ Study Start (Actual) 15 April 2024
🗓️ Primary Completion (Estimated) 1 January 2025
✅ Study Completion (Estimated) 1 May 2025
👥 Enrollment (Estimated) 150
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Dallas, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 October 2023
  • First Submitted that Met QC Criteria 31 October 2023
  • First Posted 3 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 16 April 2024
  • Last Update Posted 17 April 2024
  • Last Verified April 2024