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.
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
None
Parallel
DOT intervention
Other interventionA 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
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.
Directly observed medication adherence
Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day
Late Acute Rejection
Number of biopsy-proven rejection, clinician-assigned rejection
Hospitalization
Number of hospitalizations
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University of Florida
Lead sponsor
emocha Mobile Health, Inc.
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
