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

NCT05732779 | Recruiting

• 2 other identifiers: IRB202201809R44HL167591-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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; Remote Monitoring; Patient Engagement

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

Study Arms (2)

eMocha intervention

EXPERIMENTAL

Adolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app)

Other: DOT intervention

Standard of care

NO INTERVENTION

Adolescent patients who continue enhanced goal-setting standard of care

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

eMocha intervention

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• emocha Mobile Health, Inc.: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (4)

University of Miami, Miller School of Medicine

Coral Gables, Florida, 33146, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021, United States

RECRUITING

FSU College of Medicine

Tallahassee, Florida, 32306, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Medication Adherence; Health Behavior; Patient Participation

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Behavior

Study Officials

• Dipankar Gupta, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dipankar Gupta, MD

CONTACT

352-273-5422; dgupta@ufl.edu

Dalia Lopez-Colon, PhD

CONTACT

352-281-6723; dalylc@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 17, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)