Clinical trial NCT03691220: Improving Medication Adherence in Adolescents Who Had a Liver Transplant
Official title: Improving Medication Adherence in Adolescents Who Had a Liver Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transplant
Keywords: Intervention
Adherence
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Baylor College of Medicine
name: University of Pittsburgh
name: University of California, San Francisco
name: Children's Hospital of Michigan
name: Children's Hospital of Philadelphia
name: Emory-Children's Center
name: The Hospital for Sick Children
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Columbia University
name: Seattle Children's Hospital
name: University of Miami
name: Children's Hospital Los Angeles
First posted: 2018-10-01
Enrollment: 148
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be randomized to receive the telemetric intervention or standard of care.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* The patient is ≥ 12 and \< 20 years of age at enrollment.
* ≥2.5 years after last liver transplantation.
* Guardian's consent, adolescent assent at enrollment.
* The patient is prescribed tacrolimus.
* The patient's MLVI (SD of tacrolimus) was \> 2 when calculated by the site for a period of 2 years prior to the review date

Exclusion Criteria:

* The patient has had transplant of an organ other than liver.
* The patient is currently listed for any organ transplantation.
* The patient is expected to transition to another service (e.g., adult clinic, another
* hospital) during the two years of the study.
* Pregnant patients.
* A temporary exclusion: the patient is not medically stable or was hospitalized for \>48 consecutive hours in the past three months.
* Site PI, study PI, or Medical Monitor determines that the patient should not be a candidate for the intervention due to factors that are not covered in the above criteria.

Primary outcomes:
measure: Incidence of Rejection
timeFrame: 2 Years
Secondary outcomes:
measure: The Standard Deviation of A Series Of Tacrolimus Levels (MLVI)
timeFrame: 2 Years
measure: Incidence of Locally Determined Biopsy Proven Rejection
timeFrame: 2 Years
measure: Rate Of Locally Determined Biopsy Proven Rejection
timeFrame: 2 Years
measure: Rate of Centrally Determined Biopsy Proven Rejection
timeFrame: 2 Years
measure: Time to Rejection From Enrollment
timeFrame: 2 Years
measure: Occurrence of Death
timeFrame: 2 Years
measure: Occurrence of Re-Listing For Transplantation
timeFrame: 2 Years
measure: Mean ALT
timeFrame: 2 Years
measure: Mean maximal ALT
timeFrame: 2 Years
measure: Mean gGT
timeFrame: 2 Years
measure: Mean maximal gGT
timeFrame: 2 Years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Los Angeles
country: United States
facility: Mattel Children's Hospital UCLA
state: California
city: San Francisco
country: United States
facility: Benioff Children's Hospital UCSF
state: California
city: Miami
country: United States
facility: Miami Transplant Institute
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta/Emory
state: Georgia
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Ann Arbor
country: United States
facility: C.S.Mott Children's Hospital
state: Michigan
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Toronto
country: Canada
facility: The Hospital For Sick Children Toronto
state: Ontario
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Eyal Shemesh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.