Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: eMocha intervention Adolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app) |
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
|
| No Intervention: Standard of care Adolescent patients who continue enhanced goal-setting standard of care |
Outcome Measures
Primary Outcome Measures
- Medication adherence [12 weeks]
medication level variability index (MLVI)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Eligible participants are 10-21 years of age
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Have received a heart transplant and are followed participating pediatric heart transplant centers
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English-speaking or Spanish-speaking
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Own a smart-phone or have access to the mobile app through other devices
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Are willing to receive information through it
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Florida | Gainesville | Florida | United States | 32610 |
Sponsors and Collaborators
- University of Florida
- emocha Mobile Health, Inc.
Investigators
- Principal Investigator: Dipankar Gupta, MD, University of Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB202201809