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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Patient Engagement; Health Behavior; Immune Suppression; Heart Transplant Rejection; Medication Nonadherence; Remote Monitoring; Pediatric Heart Transplant
• Intervention / Treatment: Other: DOT intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dipankar Gupta, MD; Phone Number: 352-273-5422; Email: dgupta@ufl.edu
• Study Contact Backup: Name: Dalia Lopez-Colon, PhD; Phone Number: 352-281-6723; Email: dalylc@ufl.edu

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Recruiting
      • University of Miami, Miller School of Medicine
      • Contact: Olena Ashworth, MD; Phone Number: 801-310-9452; Email: osa5040@med.miami.edu
      • Principal Investigator: Paolo Rosconi, MD
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
      • Contact: Dipankar Gupta, MD; Phone Number: 352-273-7770; Email: dgupta@ufl.edu
      • Principal Investigator: Dipankar Gupta, MD
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • Joe DiMaggio Children's Hospital
      • Contact: Svetlana B Shugh, MD; Phone Number: 954-265-3437; Email: sshugh@mhs.net
      • Principal Investigator: Svetlana B Shuh, MD
    • Tallahassee, Florida, United States, 32306
      • Not yet recruiting
      • FSU College of Medicine
      • Contact: Mike Killian, PhD; Phone Number: 850-644-7094; Email: mkillian@fsu.edu
      • Contact: Sonnie Mayewski; Email: smayewski@fsu.edu
      • Principal Investigator: Mike Killian, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication adherence based on medication level variability index	medication level variability index (MLVI). MLVI is calculated as the Standard Deviation of a set of at least 3 tacrolimus trough blood levels for each participant.	12 weeks
Directly observed medication adherence	Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day	1 weeks
Late Acute Rejection	Number of biopsy-proven rejection, clinician-assigned rejection	6 months post-intervention
Hospitalization	Number of hospitalizations	6 months post-intervention
Patient Activation Measure	A 13-item scale designed to measure a patient's perception of their knowledge, skill and confidence in managing their chronic health condition	Pretest at enrollment and posttest at 12 weeks
Self-reported user satisfaction with the DOT app	Collected using a modified version of the engagement index questionnaire used	Pretest at enrollment and posttest at 12 weeks
Engagement metrics	Standard engagement metrics or paradata (e.g., amount, frequency, duration, and depth of use)	Pretest at enrollment and posttest at 12 weeks
PedsQL 3.0 Transplant Module (PedsQL-TM)	HRQOL	Pretest at enrollment and posttest at 12 weeks
Adolescent Medication Barriers Scale (AMBS)	To assess adolescent perceived barriers to medication adherence	Pretest, posttest
Parent Medication Barriers Scale (PMBS)	To assess parental perceived barriers to their child taking their medication	Pretest at enrollment and posttest at 12 weeks
Patient Assessment of Chronic Illness Care (PACIC)	A 20-item scale with five subscales (scale of 1 (none) to 5 (always), total score 20 to 200, higher score being better outcome) that assess patient activation, delivery system design, goal setting, problem-solving and contextual counseling, and follow-up and coordination.	Pretest at enrollment and posttest at 12 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); emocha Mobile Health, Inc.
• Investigators: Principal Investigator: Dipankar Gupta, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 6, 2023
• First Submitted That Met QC Criteria: February 8, 2023
• First Posted (Actual): February 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Patient Compliance; Patient Acceptance of Health Care; Health Behavior; Medication Adherence; Patient Participation
• Other Study ID Numbers: IRB202201809; R44HL167591-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No