Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00856895 |
| Other study ID # |
STU14943 (2689-001) |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 2007 |
| Est. completion date |
March 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Northwestern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of study is to measure the quality of life (QOL) of patients pre and post kidney
transplant by asking them to fill out a survey. Patients will be asked to fill out the survey
before transplant, 3 months post-transplant, and 1 year post-transplant to see how the
transplant relates to any progression in quality of life.
QOL will be assessed to correlate the quality of life and aspects of renal function
prospectively at pre and post-transplant across all ethnicities and variances of donor types
at three time points. First, there will be a prospective assessment of QOL in the Hispanic
and Non-Hispanic kidney recipients before and after transplant at NMH and Colombiana de
Transplantes. Second, there will be an assessment of the Hispanic kidney patients that have
been transplanted over the last 10 years at NMH and Colombiana de Transplantes, in a
cross-sectional fashion. Third, there will be a comparison and determination of the
differences in QOL in the Hispanic population before and after the Hispanic Transplant
program was initiated in November 2006. Lastly, there will be an assessment of the social
impact of the services that NMH's Hispanic Transplant Program provides to patients.
The questionnaires completed by the subjects at NMH will be the same questionnaires completed
by the subjects in Colombia. The data obtained from Colombiana de Transplantes will be
de-identified data and provided to us via a password protected excel file delivered to the
principal investigator electronically.
Description:
AIM 1: To evaluate the Quality of life in Hispanic and Non-Hispanic Kidney transplant
recipients in a prospective longitudinal study using QOL questionnaires before and after the
transplant. We propose to perform a prospective evaluation of QOL using the KDQOL-SF in every
kidney recipient that is going to be transplanted at NMH. In addition to parameters included
in the QOL instrument, we will consider ethnic background, renal function at the time of the
evaluation and type of donor (deceased vs. living donor, expanded criteria donor vs. standard
criteria donor), all of which has implications for the medical outcome of the transplant. An
enrollment for Northwestern University is set at 750 subjects with a total approved
enrollment for both sites of 1200 subjects. We plan to perform three assessments: the first
before transplant, the second three months after transplant, and the third at the one year
anniversary of the transplant. These milestones coincide with standard of care medical visits
to the transplant center at NMH. This prospective study is going to start after the
initiation of the Hispanic Kidney Transplant Program.
AIM 2: To evaluate long term QOL in Hispanic kidney transplant recipients in a
cross-sectional study of NMH patients from the last 10 years using QOL questionnaires. We
propose to enroll an equal number of Hispanic kidney recipients and Non-Hispanic kidney
recipients transplanted over the last 10 years. We will use the KDQOL-SF to assess the
current QOL in three groups according to the era of kidney transplantation: 1) Less than 1
year after transplant 2) 1-5 years after transplant and 3) 5 to 10 years post-transplant. In
addition to the KDQOL-SF, we will examine their current level of renal function and the type
of donor as was mention in the prospective part of this proposal.
AIM 3: To determine differences in QOL in Hispanic kidney transplant recipients before and
after the Hispanic transplant program at NMH was developed.
In this specific aim, we will test the hypothesis that the cultural and educational oriented
approach through the Hispanic transplant program will improve the QOL of Hispanic kidney
transplant recipients and minimize differences compared to Non-Hispanic kidney recipients. To
achieve this we will compare information from the cross-sectional evaluation in Aim 2 and the
prospective evaluation in Aim 1 providing information before and after the inception of the
Hispanic transplant program.
AIM 4: To Evaluate the social impact that the services of the NMH Hispanic Transplant program
provides to the patients that participate in it. Subjects will be given a survey to complete
about their experience and/or asked to participate in an interview about their experience
with Northwestern Memorial's Transplant Program. If subject has participated or received a
transplant and is no longer at Northwestern Memorial, a survey and letter asking for their
participation may be mailed to their residence. All names will be kept confidential. Expected
duration of subject participation is either a survey (15-20 min) or an interview (up to 1
hour).
