I-AM: Improving Medication-taking After Liver Transplant

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Completed

CT.gov ID

NCT01960322

Collaborator

University of California, Los Angeles (Other), Children's Hospital Medical Center, Cincinnati (Other), University of Pittsburgh (Other), The Emmes Company, LLC (Industry)

Enrollment

Locations

Arm

Duration (Months)

2.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Nonadherence Tacrolimus Pediatric Liver Transplant Recipients	Behavioral: Telemetric	Phase 1

Detailed Description

Nonadherence (not taking the medications as prescribed) is the most common cause of late acute rejection in children who have had a liver transplant, and thus is associated with graft loss, increased expenditures on care, and ultimately death. Researchers in this application developed a biomarker to identify nonadherence, calculating the standard deviation (SD) of consecutive immunosuppressant blood levels for each patient to capture the degree of variability between individual levels (higher SD = less consistent levels). By applying a threshold, this marker identifies nonadherent patients. A consortium of transplant centers is currently testing this marker through the MALT (Medication Adherence in children who had a Liver Transplant) study. MALT investigators now propose to take advantage of this existing collaboration to pilot-test an intervention to improve adherence in patients who are identified by this marker.

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intervention After MALT (I-AM): Feasibility of Improving Adherence Among Pediatric and Adult Cardiac Transplant Patients Using a Telemetric Intervention

Study Start Date :

Aug 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telemetric Enrolled patients will be followed for 12 months during which they will receive the study telemetry intervention.	Behavioral: Telemetric A manualized behavioral management approach focusing on avoidance and addressing barriers to adherence, delivered via telephone or internet chat applications.

Arm

Intervention/Treatment

Experimental: Telemetric

Enrolled patients will be followed for 12 months during which they will receive the study telemetry intervention.

Behavioral: Telemetric

A manualized behavioral management approach focusing on avoidance and addressing barriers to adherence, delivered via telephone or internet chat applications.

Outcome Measures

Primary Outcome Measures

Change in Adherence [at baseline and one year]
Change in Adherence at one year compared to at baseline measured via the Standard Deviation of Tacrolimus levels obtained

Secondary Outcome Measures

Change in Incidence of rejection [at baseline and at one year]
Change in Incidence of rejection compared at one year to baseline
Liver Enzyme Levels [at baseline]
Liver Enzyme Levels [at one year]
Feasibility [at one year]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 19 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Mattell Children's Hospital	Los Angeles	California	United States	90095
2	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
3	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania	United States	15224