Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DOT intervention.
- Who it may be relevant to
- Registry conditions: Heart Transplant Rejection, Immune Suppression, Pediatric Heart Transplant, Medication Nonadherence. Basic parameters: 10 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- 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
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- University of Miami, Miller School of Medicine — Coral Gables
- University of Florida — Gainesville
- Joe DiMaggio Children's Hospital — Hollywood
- FSU College of Medicine — Tallahassee
Identifiers
NCT: NCT05732779 · IRB202201809 · R44HL167591-01A1