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

Last updated: February 25, 2025
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

DOT intervention

Clinical Study ID

NCT05732779
IRB202201809
R44HL167591-01A1
  • Ages 10-21
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eligible participants are 10-21 years of age

  • Have received a heart transplant and are followed participating pediatric hearttransplant centers

  • English-speaking or Spanish-speaking

  • Own a smart-phone or have access to the mobile app through other devices

  • Are willing to receive information through it

  • Have a MLVI score of greater than 2.0 over the last year

Exclusion

Exclusion Criteria:

• Those with cognitive impairments will not be eligible for enrollment due to inability to provide informed assent

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: DOT intervention
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
March 31, 2026

Study Description

Few interventions have proven to be successful in promoting medication adherence and impacting short- and long-term post-transplant outcomes in adolescent heart transplant (HT) recipients. Improving adherence is a persistent challenge with youth experiencing chronic health conditions, especially among adolescent transplant recipients. Adolescent organ transplant recipients experience unique challenges remaining adherent to the complex post-transplant regimen, with rates of non-adherence as high as 40% to 60%. In this population, medication non-adherence 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.

Connect with a study center

  • University of Miami, Miller School of Medicine

    Coral Gables, Florida 33146
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Joe DiMaggio Children's Hospital

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • FSU College of Medicine

    Tallahassee, Florida 32306
    United States

    Site Not Available

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