Predictors and Intervention for Noncompliance

University of Minnesota273 enrolled

Overview

This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss. Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss.

Our original studies demonstrated "early" noncompliant behavior predicted adverse transplantation outcomes including acute graft rejection and graft loss. In this study, we are randomly assigning a telephone intervention in a prospective cohort of medically noncompliant patients. Standard therapy includes specifically warning patients about the risks of noncompliant behavior, and the formal intervention is randomized so half of these patients will also receive intensive telephone followup, intended to improve medication compliance and reduce adverse events.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

273

Conditions

Kidney Transplantation

Interventions

Intensive telephone followupBEHAVIORAL

Telephone calling

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Kidney transplant * Discharged from hospital with functioning graft Exclusion Criteria: * Risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal,segmental glomerulosclerosis with nephrotic syndrome * Patients with active psychosis * Patients not using azathioprine, sirolimus, or mycophenolate mofetil for immunosuppression at the time of discharge * Patients taking the liquid form of azathioprine or mycophenolate mofetil * Patients who are younger than 14 yrs. old * Patients who do not speak English * Receiving extra-renal organ except for pancreas,either simultaneously or previously * Patients who live and will be followed outside of the United States, except Canada * Patients who are physically unable to open the Medication Event Monitoring System(MEMS)cap * Patients who are not responsible for taking their own medications, e.g. living in a medical care facility

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Graft loss

Time frame: prospective

Secondary Outcomes

Acute rejection

Time frame: prospective

Death

Time frame: prospective

Data from ClinicalTrials.gov

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