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NCT05732779NARecruiting

Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients

University of Florida

Start Date

10/1/2024

Completion Date

5/1/2027

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.

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.

Eligibility Criteria

Age Range: 10 years to 21 years

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

Interventions

OTHER

DOT intervention

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Conditions

Heart Transplant RejectionImmune SuppressionPediatric Heart TransplantMedication NonadherenceHealth BehaviorRemote MonitoringPatient Engagement

Locations

University of Miami, Miller School of Medicine

Coral Gables, Florida 33146

United States

University of Florida

Gainesville, Florida 32610

United States

Joe DiMaggio Children's Hospital

Hollywood, Florida 33021

United States

FSU College of Medicine

Tallahassee, Florida 32306

United States