NCT00148187

Brief Summary

The purpose of this study is to quantitate pre-transplant medication compliance, dialysis compliance, and related psychological variables, and then examine their validity as predictors of post-transplant noncompliant behaviors and clinically relevant outcomes (acute rejection, graft loss, or death). Hypothesis: Noncompliance with pre-transplant medication or with the dialysis prescription, and specific psychological variables predict similarly noncompliant behaviors after transplantation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

June 1, 2015

Status Verified

May 1, 2015

Enrollment Period

11.8 years

First QC Date

September 2, 2005

Last Update Submit

May 28, 2015

Conditions

Kidney Transplantation

Keywords

Medication adherencePatient complianceKidney transplantOrgan rejectionAllograft lossDrug monitoring

Outcome Measures

Primary Outcomes (1)

  • Prediction of early medication adherence

    Prediction of declining medication adherence during first three months post kidney transplantation.

    3 months

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pre-operative renal transplant recipients

You may qualify if:

  • Adult hemodialysis patients in renal transplant evaluation
  • Able to read test forms
  • Responsible for their own medications

You may not qualify if:

  • Patients with a major 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 who do not speak English.
  • Patients who live and will be followed outside 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.
  • Patients who are younger than 14 years old
  • Patients who will receive an extra renal organ (except pancreas), either simultaneously or previously.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Medication AdherencePatient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Thomas E Nevins, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

January 1, 2003

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

June 1, 2015

Record last verified: 2015-05

Locations

US(1)