Predictors and Intervention for Noncompliance

This study is currently recruiting participants.

Verified April 2012 by University of Minnesota - Clinical and Translational Science Institute

Sponsor:

Collaborator:

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

Information provided by (Responsible Party):

Thomas E. Nevins, University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT00148174

First received: September 2, 2005

Last updated: April 27, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

April 27, 2012

Start Date ^ICMJE

August 1998

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Graft loss [ Time Frame: prospective ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Graft loss
Acute rejection
Death

Change History

Complete list of historical versions of study NCT00148174 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Acute rejection [ Time Frame: prospective ] [ Designated as safety issue: No ]
Death [ Time Frame: prospective ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Predictors and Intervention for Noncompliance

Official Title ^ICMJE

Predictors and Intervention for Noncompliance

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Kidney Transplantation

Intervention ^ICMJE

Behavioral: Intensive telephone followup

Telephone calling

Study Arm (s)

Active Comparator: Phone calling
Active adherence intervention by telephone

Intervention: Behavioral: Intensive telephone followup
No Intervention: Standard care
Standard of care

Intervention: Behavioral: Intensive telephone followup

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Estimated Completion Date

August 2013

Estimated Primary Completion Date

August 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 MEMS cap
Patients who are not responsible for taking their own medications, e.g. living in a medical care facility

Gender

Both

Ages

14 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Thomas E Nevins, MD

612-626-2922

nevin001@umn.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00148174

Other Study ID Numbers ^ICMJE

9611M11943, 2P01DK013083-40A1

Has Data Monitoring Committee

Yes

Responsible Party

Thomas E. Nevins, University of Minnesota - Clinical and Translational Science Institute

Study Sponsor ^ICMJE

University of Minnesota - Clinical and Translational Science Institute

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Thomas E Nevins, MD

University of Minnesota - Clinical and Translational Science Institute

Information Provided By

University of Minnesota - Clinical and Translational Science Institute

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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