Prediction of Medication Compliance Following Renal Transplantation
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Purpose
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.
| Condition |
|---|
|
Kidney Transplantation |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prediction of Medication Compliance Following Renal Transplantation |
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
This pilot study is intended to provide preliminary data about the feasibility of recruiting a cohort of subjects on hemodialysis and following them prospectively through the transplant procedure. The study will document patient adherence to medications and treatment, both before and after surgery. These preliminary data will permit appropriate design and power calculations for a future study assessing our ability to predict post-transplant compliance, based on pre-transplant behaviors.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Pre-operative renal transplant recipients
Inclusion Criteria:
- Adult hemodialysis patients in renal transplant evaluation
- Able to read test forms
- Responsible for their own medications
Exclusion Criteria:
- 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 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.
Contacts and Locations| Contact: Thomas E Nevins, MD | 612-626-2922 | nevin001@umn.edu |
| United States, Minnesota | |
| University of Minnesota | Recruiting |
| Minneapolis, Minnesota, United States, 55455 | |
| Contact: Thomas E Nevins, MD 612-626-2922 nevin001@umn.edu | |
| 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: | NCT00148187 History of Changes |
| Other Study ID Numbers: | 0202M17442, 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 June 17, 2013