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

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
University of Florida
Study ID
NCT05732779
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
10 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • DOT intervention — OTHER
    A mobile health application developed by eMocha Health Inc. facilitates asynchronous mobile video directly observed therapy (DOT) intervention, empowering users to track dose-by-dose medication adherence

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Feb 2026
Primary completion
Feb 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: eMocha intervention
    Adolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app)
  • No Intervention: Standard of care
    Adolescent patients who continue enhanced goal-setting standard of care

Primary Outcome Measure

Medication adherence based on medication level variability index [ Time Frame: 12 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of Miami, Miller School of MedicineCoral GablesFlorida33146
Olena Ashworth, MD
[email protected]
801-310-9452
Paolo Rosconi, MD (PRINCIPAL_INVESTIGATOR)
University of FloridaGainesvilleFlorida32610
Dipankar Gupta, MD
[email protected]
352-273-7770
Dipankar Gupta, MD (PRINCIPAL_INVESTIGATOR)
Joe DiMaggio Children's HospitalHollywoodFlorida33021
Svetlana B Shugh, MD
[email protected]
954-265-3437
Svetlana B Shuh, MD (PRINCIPAL_INVESTIGATOR)
FSU College of MedicineTallahasseeFlorida32306
Mike Killian, PhD
[email protected]
850-644-7094
Sonnie Mayewski
[email protected]
Mike Killian, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Coral Gables, FL

By research site
University of Miami, Miller School of Medicine· Coral Gables, FLUniversity of Florida· Gainesville, FLJoe DiMaggio Children's Hospital· Hollywood, FLFSU College of Medicine· Tallahassee, FL

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