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Predictors and Intervention for Noncompliance

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00148174
First received: September 2, 2005
Last updated: May 28, 2015
Last verified: May 2015

September 2, 2005
May 28, 2015
August 1998
November 2014   (final data collection date for primary outcome measure)
Graft loss [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Acute rejection
  • Graft loss
  • Death
Complete list of historical versions of study NCT00148174 on ClinicalTrials.gov Archive Site
  • Acute rejection [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Death [ Time Frame: prospective ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Predictors and Intervention for Noncompliance
Predictors and Intervention for Noncompliance

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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Transplantation
Behavioral: Intensive telephone followup
Telephone calling
Experimental: Phone calling
Phone calling to encourage improved adherence
Intervention: Behavioral: Intensive telephone followup
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
273
December 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
14 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00148174
9611M11943, 2P01DK013083-40A1
Yes
Not Provided
Not Provided
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Thomas E Nevins, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
May 2015

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