Predictors and Intervention for Noncompliance

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Predictors and Intervention for Noncompliance

Conditions
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Kidney Transplantation

Intervention / Treatment
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* Behavioral: Intensive telephone followup


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phone calling<br>Phone calling to encourage improved adherence | Behavioral: Intensive telephone followup<br>* Telephone calling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft loss |  | prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute rejection |  | prospective | 
| Death |  | prospective | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, Patient compliance, Kidney transplant, Organ rejection, Allograft loss, Drug monitoring