COMPLETED

Food Supplementation Delivered Conditionally vs Not Among Patients With Heart Failure

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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?

Official Title

Examining the Impact of Medically Tailored Meals vs Produce Supplements Delivered Conditionally vs Not on Health Engagement and Health Outcomes Among Patients With Heart Failure

Quick Facts

Study Start:2024-04-15
Study Completion:2025-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06115369

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults over 18 years age with a recent hospitalization for acute decompensated HF
  1. * Baseline hyperkalemia with K \> 5.5 mEq/L or history of hyperkalemia requiring hospitalization for urgent treatment,
  2. * Receipt of a heart transplant or left ventricular assist device,
  3. * Use of inotropic therapy at hospital discharge,
  4. * Discharge to a skilled nursing facility or long-term care facility that provides prepared patient meals, comorbidity with expected survival \< 6 months, and
  5. * Inability to provide an address to receive produce shipments (including unhoused individuals or individuals residing in temporary housing shelters).
  6. * Pregnancy

Contacts and Locations

Principal Investigator

Ambarish Pandey
PRINCIPAL_INVESTIGATOR
UT Southwestern

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Ambarish Pandey, PRINCIPAL_INVESTIGATOR, UT Southwestern

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

Study Start Date2024-04-15
Study Completion Date2025-10-30

Study Record Updates

Study Start Date2024-04-15
Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

  • Heart Failure
  • Produce
  • Medically Tailored Meals
  • Patient Participation

Additional Relevant MeSH Terms

  • Heart Failure