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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
University of Miami, Miller School of Medicine
Coral Gables, Florida, United States
RECRUITINGUniversity of Florida
Gainesville, Florida, United States
RECRUITINGJoe DiMaggio Children's Hospital
Hollywood, Florida, United States
RECRUITINGFSU College of Medicine
Tallahassee, Florida, United States
NOT_YET_RECRUITINGMedication 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.
Time frame: 12 weeks
Directly observed medication adherence
Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day
Time frame: 1 weeks
Late Acute Rejection
Number of biopsy-proven rejection, clinician-assigned rejection
Time frame: 6 months post-intervention
Hospitalization
Number of hospitalizations
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Pretest at enrollment and posttest at 12 weeks
Engagement metrics
Standard engagement metrics or paradata (e.g., amount, frequency, duration, and depth of use)
Time frame: Pretest at enrollment and posttest at 12 weeks
PedsQL 3.0 Transplant Module (PedsQL-TM)
HRQOL
Time frame: Pretest at enrollment and posttest at 12 weeks
Adolescent Medication Barriers Scale (AMBS)
To assess adolescent perceived barriers to medication adherence
Time frame: Pretest, posttest
Parent Medication Barriers Scale (PMBS)
To assess parental perceived barriers to their child taking their medication
Time frame: Pretest at enrollment and posttest at 12 weeks
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