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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
  Purpose

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.


Condition Intervention
Kidney Transplantation
 Behavioral: Intensive telephone followup

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Predictors and Intervention for Noncompliance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Graft loss [ Time Frame: prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute rejection [ Time Frame: prospective ] [ Designated as safety issue: No ]
  • Death [ Time Frame: prospective ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: August 1998
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Phone calling
Active adherence intervention by telephone
 Behavioral: Intensive telephone followup
Telephone calling
No Intervention: Standard care
Standard of care
 Behavioral: Intensive telephone followup
Telephone calling

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.

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 MEMS cap
  • Patients who are not responsible for taking their own medications, e.g. living in a medical care facility
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148174

Contacts
Contact: Thomas E Nevins, MD 612-626-2922 nevin001@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Thomas E Nevins, MD     612-626-2922     nevin001@umn.edu    
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Thomas E Nevins, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Thomas E. Nevins, MD, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00148174     History of Changes
Other Study ID Numbers: 9611M11943, 2P01DK013083-40A1
Study First Received: September 2, 2005
Last Updated: April 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Medication adherence
Patient compliance
Kidney transplant
 Organ rejection
Allograft loss
Drug monitoring

ClinicalTrials.gov processed this record on May 16, 2013