Actively Recruiting

Phase Not Applicable
Age: 10Years - 21Years
All Genders
NCT05732779

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

Led by University of Florida · Updated on 2026-02-27

100

Participants Needed

4

Research Sites

134 weeks

Total Duration

On this page

Sponsors

U

University of Florida

Lead Sponsor

E

emocha Mobile Health, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 10Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 10 and 21 years
  • Received a heart transplant and followed at participating pediatric heart transplant centers
  • Speaks English or Spanish
  • Owns a smartphone or can access the mobile app via other devices
  • Willing to receive information through the app
  • Has a medication level variability index (MLVI) score greater than 2.0 over the last year
Not Eligible

You will not qualify if you...

  • Cognitive impairments preventing the ability to provide informed assent

AI-Screening

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Trial Site Locations

Total: 4 locations

1

University of Miami, Miller School of Medicine

Coral Gables, Florida, United States, 33146

Actively Recruiting

2

University of Florida

Gainesville, Florida, United States, 32610

Actively Recruiting

3

Joe DiMaggio Children's Hospital

Hollywood, Florida, United States, 33021

Actively Recruiting

4

FSU College of Medicine

Tallahassee, Florida, United States, 32306

Not Yet Recruiting

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Research Team

D

Dipankar Gupta, MD

CONTACT

D

Dalia Lopez-Colon, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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