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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
A manualized behavioral management approach focusing on avoidance and addressing barriers to adherence, delivered via telephone or internet chat applications.
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
Change in Adherence
Change in Adherence at one year compared to at baseline measured via the Standard Deviation of Tacrolimus levels obtained
Time frame: at baseline and one year
Change in Incidence of rejection
Change in Incidence of rejection compared at one year to baseline
Time frame: at baseline and at one year
Liver Enzyme Levels
Time frame: at baseline
Liver Enzyme Levels
Time frame: at one year
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)
Time frame: at one year
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