Predictors and Intervention for Noncompliance

University of Minnesota (UMN) logo

University of Minnesota (UMN)

Status

Completed

Conditions

Kidney Transplantation

Treatments

Behavioral: Intensive telephone followup

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00148174
2P01DK013083-40A1 (U.S. NIH Grant/Contract)
9611M11943

Details and patient eligibility

About

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.

Full 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.

Enrollment

273 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

273 participants in 1 patient group

Phone calling
Experimental group
Description:
Phone calling to encourage improved adherence
Treatment:
Behavioral: Intensive telephone followup

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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