An interventional study of DOT intervention in Heart Transplant Rejection, Immune Suppression and Pediatric Heart Transplant, sponsored by University of Florida. Recruiting at 4 sites in United States. Open to participants aged 10 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
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.
937 studies on the registry are indexed under Medication Adherence; 159 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 768 interventional studies indexed under Medication Adherence.
Browse Medication Adherence studies →University of Florida is the lead sponsor of 1,287 studies on the registry; 199 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 143 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app)
Other: DOT intervention
Adolescent patients who continue enhanced goal-setting standard of care
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
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.
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
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Feb 2027, 28 months after the start.
Of 425 non-industry interventional studies with no phase under Medication Adherence, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's planned 28 months is above that.
Counting every sponsor, half of 442 studies reached it within 21 months; a quarter within 11 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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