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

Not Applicable

Recruiting

• Conditions: Immune Suppression; Pediatric Heart Transplant; Health Behavior; Heart Transplant Rejection; Medication Nonadherence; Remote Monitoring; Patient Engagement
• Interventions: Other: DOT intervention

• Registration Number: NCT05732779
• Lead Sponsor: University of Florida

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.

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 Timeline

• Study First Submitted: 2023-02-06
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Study Start: 2024-10-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
PedsQL 3.0 Transplant Module (PedsQL-TM)	Pretest at enrollment and posttest at 12 weeks	HRQOL
Medication adherence based on medication level variability index	12 weeks	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.
Directly observed medication adherence	1 weeks	Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day
Hospitalization	6 months post-intervention	Number of hospitalizations
Patient Activation Measure	Pretest at enrollment and posttest at 12 weeks	A 13-item scale designed to measure a patient's perception of their knowledge, skill and confidence in managing their chronic health condition
Engagement metrics	Pretest at enrollment and posttest at 12 weeks	Standard engagement metrics or paradata (e.g., amount, frequency, duration, and depth of use)
Adolescent Medication Barriers Scale (AMBS)	Pretest, posttest	To assess adolescent perceived barriers to medication adherence
Parent Medication Barriers Scale (PMBS)	Pretest at enrollment and posttest at 12 weeks	To assess parental perceived barriers to their child taking their medication
Late Acute Rejection	6 months post-intervention	Number of biopsy-proven rejection, clinician-assigned rejection
Patient Assessment of Chronic Illness Care (PACIC)	Pretest at enrollment and posttest at 12 weeks	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.
Self-reported user satisfaction with the DOT app	Pretest at enrollment and posttest at 12 weeks	Collected using a modified version of the engagement index questionnaire used

Trial Locations

Locations (4)

University of Florida; 🇺🇸 Gainesville, Florida, United States

University of Miami, Miller School of Medicine; 🇺🇸 Coral Gables, Florida, United States

Joe DiMaggio Children's Hospital; 🇺🇸 Hollywood, Florida, United States

FSU College of Medicine; 🇺🇸 Tallahassee, Florida, United States