Clinical trial NCT05732779: Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients
Official title: Mobile Video Directly Observed Therapy (DOT) for Immunosuppression Medication Adherence in Adolescent Heart Transplant Recipients: Enhancing Technological Innovation and Strengthening the Role of Small Businesses in Meeting Needs of Adolescent Organ Transplant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Transplant Rejection
Immune Suppression
Pediatric Heart Transplant
Medication Nonadherence
Health Behavior
Remote Monitoring
Patient Engagement
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: emocha Mobile Health, Inc.
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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: 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

Primary outcomes:
measure: Medication adherence based on medication level variability index
timeFrame: 12 weeks
measure: Directly observed medication adherence
timeFrame: 1 weeks
measure: Late Acute Rejection
timeFrame: 6 months post-intervention
measure: Hospitalization
timeFrame: 6 months post-intervention
measure: Patient Activation Measure
timeFrame: Pretest at enrollment and posttest at 12 weeks
measure: Patient Assessment of Chronic Illness Care (PACIC)
timeFrame: Pretest at enrollment and posttest at 12 weeks
measure: Self-reported user satisfaction with the DOT app
timeFrame: Pretest at enrollment and posttest at 12 weeks
measure: Engagement metrics
timeFrame: Pretest at enrollment and posttest at 12 weeks
measure: PedsQL 3.0 Transplant Module (PedsQL-TM)
timeFrame: Pretest at enrollment and posttest at 12 weeks
measure: Adolescent Medication Barriers Scale (AMBS)
timeFrame: Pretest, posttest
measure: Parent Medication Barriers Scale (PMBS)
timeFrame: Pretest at enrollment and posttest at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami, Miller School of Medicine
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hollywood
country: United States
facility: Joe DiMaggio Children's Hospital
state: Florida
city: Tallahassee
country: United States
facility: FSU College of Medicine
state: Florida
Study officials:
affiliation: University of Florida
name: Dipankar Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References: