RECRUITING

Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients

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

We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes.

Official Title

Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients: Enhancing Technological Innovation and Strengthening the Role of Small Businesses in Meeting Needs of Adolescent Organ Transplant

Quick Facts

Study Start:2024-10-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05732779

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:10 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Eligible participants are 10-21 years of age
  2. * Have received a heart transplant and are followed participating pediatric heart transplant centers
  3. * English-speaking or Spanish-speaking
  4. * Own a smart-phone or have access to the mobile app through other devices
  5. * Are willing to receive information through it
  6. * Have a MLVI score of greater than 2.0 over the last year
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Dipankar Gupta, MD
CONTACT
352-273-5422
dgupta@ufl.edu
Dalia Lopez-Colon, PhD
CONTACT
352-281-6723
dalylc@ufl.edu

Principal Investigator

Dipankar Gupta, MD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Miami, Miller School of Medicine
Coral Gables, Florida, 33146
United States
University of Florida
Gainesville, Florida, 32610
United States
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
United States
FSU College of Medicine
Tallahassee, Florida, 32306
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Dipankar Gupta, MD, PRINCIPAL_INVESTIGATOR, University of Florida

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 Date2024-10-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Transplant Rejection
  • Immune Suppression
  • Pediatric Heart Transplant
  • Medication Nonadherence
  • Health Behavior
  • Remote Monitoring
  • Patient Engagement