NCT05732779 · University of Florida
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
What this study is about
We will conduct a two-group randomly assigned 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.
View original scientific description
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.
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
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
Time frame: 1 weeks
Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day
Late Acute Rejection
Time frame: 6 months post-intervention
Number of biopsy-proven rejection, clinician-assigned rejection
Hospitalization
Time frame: 6 months post-intervention
Number of hospitalizations
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
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.
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
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)
PedsQL 3.0 Transplant Module (PedsQL-TM)
Time frame: Pretest at enrollment and posttest at 12 weeks
HRQOL
Adolescent Medication Barriers Scale (AMBS)
Time frame: Pretest, posttest
To assess adolescent perceived barriers to medication adherence
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Coral Gables, Florida
- Gainesville, Florida
- Hollywood, Florida
- Tallahassee, Florida
Collaborators
emocha Mobile Health, Inc., National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations