Quality of Life in Pre and Post Renal Transplant in Hispanic and Non-Hispanic Recipients (QOL)

April 24, 2025 updated by: Juan Caicedo, Northwestern University

Evaluation of Quality of Life Pre and Post Renal Transplant in Hispanic and Non-Hispanic Recipients

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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).

Study Type

Observational

Enrollment (Estimated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A total of 1779 kidney transplants have been performed in the last 10 years in NMH, and 220 of those kidney transplants were done in Hispanics recipients. Informed consent will be required to participate in the study.

Description

Inclusion Criteria:

  • Pre or post renal transplant recipients ≥ 18 years of age
  • Male or female
  • Receiving medical care at Northwestern Memorial Hospital
  • Able to read, understand and have the ability to sign the consent form and authorization for research

Exclusion Criteria:

  • Pre or post renal transplant recipients < 18 years of age
  • Received transplant outside of Northwestern Memorial Hospital
  • Those unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Hispanic
Non-Hispanic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the QOL in Hispanic and non-Hispanic Kidney Transplant Recipients
Time Frame: Oct. 2007 - December 2015
To evaluate long term QOL outcomes in Hispanic and Non-Hispanic kidney transplant recipients in a prospective longitudinal study using QOL questionnaires before and after transplant.
Oct. 2007 - December 2015

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate Long Term QOL Outcomes in Hispanic and Non-Hispanic Kidney Transplant Recipients
Time Frame: Oct. 2007 - December 2015
To evaluate long term QOL outcomes in Hispanic and Non-hispanic kidney transplant recipients in a cross-sectional study of Northwestern Memorial Hospital patients from the last 10 years using QOL questionnaires.
Oct. 2007 - December 2015

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the differences in QOL outcomes in Hispanic and Non-Hispanic kidney transplant recipients
Time Frame: Oct. 2007 - December 2015
To determine the differences in QOL outcomes in Hispanic kidney transplant recipients before and after recently implemented Hispanic transplant program was developed.
Oct. 2007 - December 2015
To Assess the social impact that services that Northwestern Memorial Hospital's Hispanic Transplant Program
Time Frame: Oct. 2007 - December 2015
To Assess the social impact that services that Northwestern Memorial Hospital's Hispanic Transplant Program provides to its patients.
Oct. 2007 - December 2015

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Northwestern Memorial Hospital

Investigators

  • Principal Investigator: Juan Carlos Caicedo, MD, Northwestern University, Northwestern Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 4, 2009

First Posted (Estimated)

March 6, 2009

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU14943 (2689-001)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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