Recruiting

Mobile Video DOT

Sponsor:

University of Florida

Code:

NCT05732779

Conditions

Heart Transplant Rejection

Immune Suppression

Pediatric Heart Transplant

Medication Nonadherence

Health Behavior

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Not accepted

Interventions

DOT intervention

Study Details

Brief 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.

Conditions

Heart Transplant Rejection

Immune Suppression

Pediatric Heart Transplant

Medication Nonadherence

Health Behavior

Study ID

NCT05732779

Start date

Oct 1, 2024

Status verified date

Feb, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Eligible participants are 10-21 years of age
  • Have received a heart transplant and are followed participating pediatric heart transplant 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 Criteria:

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

DOT intervention

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

Primary outcome measure

  • Medication adherence based on medication level variability index [ Time Frame: 12 weeks ]
  • Directly observed medication adherence [ Time Frame: 1 weeks ]
  • Late Acute Rejection [ Time Frame: 6 months post-intervention ]
  • Hospitalization [ Time Frame: 6 months post-intervention ]
  • Patient Activation Measure [ Time Frame: Pretest at enrollment and posttest at 12 weeks ]
  • Patient Assessment of Chronic Illness Care (PACIC) [ Time Frame: Pretest at enrollment and posttest at 12 weeks ]
  • Self-reported user satisfaction with the DOT app [ Time Frame: Pretest at enrollment and posttest at 12 weeks ]
  • Engagement metrics [ Time Frame: Pretest at enrollment and posttest at 12 weeks ]
  • PedsQL 3.0 Transplant Module (PedsQL-TM) [ Time Frame: Pretest at enrollment and posttest at 12 weeks ]
  • Adolescent Medication Barriers Scale (AMBS) [ Time Frame: Pretest, posttest ]
  • Parent Medication Barriers Scale (PMBS) [ Time Frame: Pretest at enrollment and posttest at 12 weeks ]

Central Contacts and Locations

Central contacts

Dipankar Gupta, MD

352-273-5422dgupta@ufl.edu

Dalia Lopez-Colon, PhD

352-281-6723dalylc@ufl.edu

Locations

University of Miami, Miller School of Medicine

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Olena Ashworth, MD

801-310-9452osa5040@med.miami.edu

Principal Investigator:

Paolo Rosconi, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Dipankar Gupta, MD

352-273-7770dgupta@ufl.edu

Principal Investigator:

Dipankar Gupta, MD

Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Svetlana B Shugh, MD

954-265-3437sshugh@mhs.net

Principal Investigator:

Svetlana B Shuh, MD

More Information

Sponsor

University of Florida

Last update posted

Jul 16, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Florida on 2026-07-16.