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

University of Florida

Status: Enrolling

Conditions: Pediatric Heart Transplant; Heart Transplant Rejection; Remote Monitoring; Medication Nonadherence; Health Behavior; Patient Engagement; Immune Suppression

Treatments: Other: DOT intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05732779

R44HL167591-01A1 (U.S. NIH Grant/Contract)

IRB202201809

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 10 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

eMocha intervention

Experimental group

Description:

Adolescent patients randomized to the use of asynchronous mobile video directly observed therapy (DOT) intervention (eMocha DOT app)

Treatment:

Other: DOT intervention

Standard of care

No Intervention group

Description:

Adolescent patients who continue enhanced goal-setting standard of care