Predictors and Intervention for Noncompliance

NCT ID: NCT00148174

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 273 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31
• Study Completion Date: 2014-12-31

Brief Summary

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

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.

Conditions

Kidney Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phone calling

Phone calling to encourage improved adherence

Group Type: EXPERIMENTAL

Intensive telephone followup

Intervention Type: BEHAVIORAL

Telephone calling

Interventions

Intensive telephone followup

Telephone calling

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas E Nevins, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

2P01DK013083-40A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

9611M11943

Identifier Type: -

Identifier Source: org_study_id