NCT05732779 Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
| NCT ID | NCT05732779 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Heart Transplant Rejection |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2027-02-01 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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