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NCT Number: NCT05732779

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

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.

Recruiting

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Key information

Conditions

Heart Transplant Rejection Behavior Health Behavior Immune Suppression Medication Adherence Medication Nonadherence Patient Acceptance of Health Care Patient Compliance Patient Engagement Patient Participation Pediatric Heart Transplant Remote Monitoring Treatment Adherence and Compliance

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Medication adherence based on medication level variability index

    Time frame: 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.

  2. Directly observed medication adherence

    Time frame: 1 weeks

    Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day

  3. Late Acute Rejection

    Time frame: 6 months post-intervention

    Number of biopsy-proven rejection, clinician-assigned rejection

  4. Hospitalization

    Time frame: 6 months post-intervention

    Number of hospitalizations

  5. Patient Activation Measure

    Time frame: 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

  6. Patient Assessment of Chronic Illness Care (PACIC)

    Time frame: 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.

  7. Self-reported user satisfaction with the DOT app

    Time frame: Pretest at enrollment and posttest at 12 weeks

    Collected using a modified version of the engagement index questionnaire used

  8. Engagement metrics

    Time frame: Pretest at enrollment and posttest at 12 weeks

    Standard engagement metrics or paradata (e.g., amount, frequency, duration, and depth of use)

  9. PedsQL 3.0 Transplant Module (PedsQL-TM)

    Time frame: Pretest at enrollment and posttest at 12 weeks

    HRQOL

  10. Adolescent Medication Barriers Scale (AMBS)

    Time frame: Pretest, posttest

    To assess adolescent perceived barriers to medication adherence

  11. Parent Medication Barriers Scale (PMBS)

    Time frame: Pretest at enrollment and posttest at 12 weeks

    To assess parental perceived barriers to their child taking their medication

Study contacts

Contact information is provided by the study sponsor or research team.

Dalia Lopez-Colon, PhD

CONTACT

[email protected]

352-281-6723

Dipankar Gupta, MD

CONTACT

[email protected]

352-273-5422

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • emocha Mobile Health, Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 17, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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