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Completed

NCT Number: NCT00148174

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.

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Key information

Conditions

Kidney Transplantation Behavior Health Behavior Medication Adherence Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intensive telephone followup

Behavioral

Telephone calling

Primary outcomes

  1. Graft loss

    Time frame: prospective

Secondary outcomes

  1. Acute rejection

    Time frame: prospective

  2. Death

    Time frame: prospective

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

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

Registry information

Important dates

Study start
1998
Primary completion
2014
Study completion
2014
First posted
Sep 7, 2005
Registry last updated
Jun 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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