Improving Medication-taking After Liver Transplant

Completed · Phase 1

Conditions studied: Nonadherence, Tacrolimus, Pediatric Liver Transplant Recipients

In brief

The specific aim is to pilot-test our developed intervention manual's ability to improve patients' adherence to medications and medical outcomes (rejection rate, liver enzyme levels) in participating centers.

Key facts

Study ID

NCT01960322

Run by

Icahn School of Medicine at Mount Sinai

People needed

7

Starts

2014-08-01

Expected to finish

2016-05-01

Last updated by the study team

2016-07-01

Who can join

Age: 11 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient is between 11-19 years of age at enrollment.
• Guardian's consent, child assent (in accordance with each institution's IRB policies).
• The patient is prescribed tacrolimus (either brand or generic formulation).
• The patient has been seen in the enrolling center's clinic at least once in the last two years.
• The patient's SD of tacrolimus was > 2.0 in the year prior to enrollment, with at least 3 levels present to make this determination.
• The patient and at least one guardian speaks English or Spanish at a level that allows her / him to understand the study procedures and consent to the study.

You may not qualify if…

• The patient received a liver transplant less than 1 year prior to enrollment.
• The patient has had more than one transplant (including marrow replacement).
• The patient has had biopsy-proven rejection within the past six months.
• The patient has been diagnosed with Hepatitis C.
• The treating physician has instructed the patient not to obtain tacrolimus levels for at least one year in the past year.
• The guardian or child (in a developmentally-appropriate manner) do not understand the study procedures. This will be verified by asking both guardian and child to repeat the study procedures.
• The patient is only seen for consultation - most or all of the child's routine care is provided at another center (or in a community clinic).
• Either the patient or the guardian is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severely mentally retarded as defined in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).
• The patient is not medically stable or is hospitalized.

Where it is running

• UCLA Mattell Children's Hospital — Los Angeles, California, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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