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

NCT00856895 | Active Not Recruiting

• 1 other identifier: STU14943 (2689-001)
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transplant; Failure, Kidney

Keywords

Improved Life Quality

Outcome Measures

Primary Outcomes (1)

• Evaluate the QOL in Hispanic and non-Hispanic Kidney Transplant Recipients

  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 Outcomes (1)

• Evaluate Long Term QOL Outcomes in Hispanic and Non-Hispanic Kidney Transplant Recipients

  Oct. 2007 - December 2015

Other Outcomes (2)

• To determine the differences in QOL outcomes in Hispanic and Non-Hispanic kidney transplant recipients

  Oct. 2007 - December 2015

• To Assess the social impact that services that Northwestern Memorial Hospital's Hispanic Transplant Program

  Oct. 2007 - December 2015

Study Arms (2)

Hispanic

Non-Hispanic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern Memorial Hospital: collaborator

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Study Officials

• Juan Carlos Caicedo, MD

  Northwestern University, Northwestern Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery; Directory of Hispanic Transplant Program,Division of Organ Transplantation, Dept of Surgery

Study Record Dates

• First Submitted: March 3, 2009
• First Posted: March 6, 2009
• Study Start: October 1, 2007
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)