NCT03691220

Improving Medication Adherence in Adolescents Who Had a Liver Transplant

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 148 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 12 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The study's aim is to test a tailored telemetric intervention to reduce rejection incidence by improving medication adherence in a group of adolescent liver transplant recipients identified as nonadherent by a marker (the Medication Level Variability Index, MLVI).

Detailed description

This is a prospective, multi-center, randomized controlled trial. The study will be conducted in transplant centers in the United States and Canada. Estimated final sample size of 140 after attrition. Pediatric adolescent and young adult (age at enrollment ≥12 and \< 20) transplant recipients will be eligible for participation in the study. Eligible participants will be randomly assigned to intervention or control group. An interim analysis to evaluate efficacy will be performed. Missing data will not be imputed for secondary analyses.

Conditions

• Transplant

Interventions

Type	Name	Description
BEHAVIORAL	Telemetric Intervention	Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.

Timeline

• Start date: 2018-11-14
• Primary completion: 2025-10-22
• Completion: 2025-10-22
• First posted: 2018-10-01
• Last updated: 2026-01-07

Locations

13 sites across 2 countries: United States, Canada