Mobile Video Directly Observed Therapy for Adolescent Heart Transplant Medication Adherence
This study is looking at a new way to help teenagers (ages 10-21) who have had a heart transplant take their immunosuppression medication regularly. Many young people struggle to take their medicines as prescribed, which can lead to serious problems like rejection of the new heart. The study will test a mobile app called eMocha DOT, which uses video to help track if you're taking your medication dose-by-dose. Researchers want to see if using this app improves how well you take your medicine and reduces the risk of your body rejecting the transplanted heart. The study aims to enroll 100 participants.
- Study design
- This is a randomized controlled trial, meaning participants will be randomly assigned to one of two groups. The study plans to enroll 100 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Medication adherence will be measured at 1 and 12 weeks. Late acute rejection will be measured at 6 months after the intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
At a glance
Conditions
NCT05732779
Where you'd take part
This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
FSU College of Medicine
Tallahassee, Floridastudy coordinator listed
Not yet recruiting
Joe DiMaggio Children's Hospital
Hollywood, Floridastudy coordinator listed
Recruiting
University of Florida
Gainesville, Floridastudy coordinator listed
Recruiting
University of Miami, Miller School of Medicine
Coral Gables, Floridastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Dipankar Gupta, MD · PRINCIPAL_INVESTIGATOR · University of Florida
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
What this trial measures
- Medication adherence based on medication level variability index12 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 adherence1 weeks
Number of doses observed and reviewed by nursing staff compare to number of prescribed doses per day
- Late Acute Rejection6 months post-intervention
Number of biopsy-proven rejection, clinician-assigned rejection
- Hospitalization6 months post-intervention
Number of hospitalizations
- Patient Activation MeasurePretest 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)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 appPretest at enrollment and posttest at 12 weeks
Collected using a modified version of the engagement index questionnaire used
- Engagement metricsPretest 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)Pretest at enrollment and posttest at 12 weeks
HRQOL
- Adolescent Medication Barriers Scale (AMBS)Pretest, posttest
To assess adolescent perceived barriers to medication adherence
- Parent Medication Barriers Scale (PMBS)Pretest at enrollment and posttest at 12 weeks
To assess parental perceived barriers to their child taking their medication