Tacrolimus Clinical Trial
— I-AMOfficial title:
Intervention After MALT (I-AM): Feasibility of Improving Adherence Among Pediatric and Adult Cardiac Transplant Patients Using a Telemetric Intervention
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 11 Years to 19 Years |
Eligibility |
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 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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | UCLA Mattell Children's Hospital | Los Angeles | California |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai | Children's Hospital Medical Center, Cincinnati, Children's Hospital of Pittsburgh, The EMMES Corporation, University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Adherence | Change in Adherence at one year compared to at baseline measured via the Standard Deviation of Tacrolimus levels obtained | at baseline and one year | No |
Secondary | Change in Incidence of rejection | Change in Incidence of rejection compared at one year to baseline | at baseline and at one year | No |
Secondary | Liver Enzyme Levels | at baseline | No | |
Secondary | Liver Enzyme Levels | at one year | No | |
Secondary | Feasibility | Participation in the intervention (receive all of the remote interactions called for in the manual, presented as a percentage of received / offered during the intervention active phase, 1 year) | at one year | No |
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