NCT01960322

Improving Medication-taking After Liver Transplant

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 11 Years – 19 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Nonadherence
• Tacrolimus
• Pediatric Liver Transplant Recipients

Interventions

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

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2013-10-10
• Last updated: 2016-07-01

Locations

3 sites across 1 country: United States