Improving Medication-taking After Liver Transplant (NCT01960322) | Clinical Trial Compass
CompletedPhase 1
Improving Medication-taking After Liver Transplant
United States7 participantsStarted 2014-08
Plain-language summary
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.
Who can participate
Age range11 Years – 19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 a…