Actively Recruiting
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
Led by University of Florida · Updated on 2026-02-27
100
Participants Needed
4
Research Sites
12 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
Researchers are evaluating a mobile video directly observed therapy (DOT) intervention to support medication adherence in adolescent heart transplant recipients. Medication nonadherence in this group is a major cause of late acute rejection, hospitalizations, graft failure, and mortality. This trial aims to improve adherence and patient outcomes using innovative technology, addressing challenges unique to youth managing complex post-transplant regimens. Participants are randomly assigned to one of two groups: those using the eMocha DOT app, which allows asynchronous mobile video observation of medication taking, and those receiving enhanced goal-setting as standard care. The study monitors medication adherence and patient engagement over 12 weeks and tracks clinical outcomes including rejection episodes and hospitalizations for 6 months post-intervention. During the study, participants will complete assessments including medication adherence measured by medication level variability index and direct observation, patient activation, chronic illness care evaluation, user satisfaction, and quality of life questionnaires at enrollment and after 12 weeks. Researchers will also monitor late acute rejection and hospitalizations over 6 months. The total participation period includes 12 weeks of intervention and follow-up evaluations extending to 6 months.
CONDITIONS
Brief Title
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 10 to 21 years
- Have received a heart transplant and are followed at participating pediatric heart transplant centers
- Speak English or Spanish
- Own a smartphone or have access to the mobile app through other devices
- Willing to receive information through the app
- Have a medication level variability index (MLVI) score greater than 2.0 over the last year
You will not qualify if you...
- Cognitive impairments that prevent providing informed assent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - 12 weeks
Participants use the asynchronous mobile video directly observed therapy (DOT) app or continue standard care to promote medication adherence.
Weekly visits (in-person or remote) for medication adherence monitoring and assessments
Duration - 6 months post-intervention
Participants are monitored for late acute rejection, hospitalizations, and continued medication adherence outcomes.
Periodic visits or remote assessments over 6 months post-treatment
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
Research Team
D
Dipankar Gupta, MD
D
Dalia Lopez-Colon, PhD
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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