Extending Veteran Participation in the Validation of the Spinal Cord Injury-Quality Of Life/Computerized Adaptive Test (SCI-QOL/CAT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01238549|
Recruitment Status : Active, not recruiting
First Posted : November 10, 2010
Last Update Posted : August 18, 2016
The field of spinal cord injury (SCI) rehabilitation medicine lacks a reliable, patient reported, health-related quality of life measurement tool. The National Institute of Health has provided funding to develop a SCI-specific, quality of life (QOL) survey tool in non-Veterans with SCI called the SCI-QOL. This quality of life survey asks questions regarding physical/medical, emotional, and social health as it relates to individuals with spinal cord injury.
The purpose of this study is to include a Veteran population in the making of the quality of life survey. Each participant will be asked to complete a packet of quality of life questions. Participants will be given the opportunity to take the survey a second time, either 7-14 days or 5-7 months after the first survey. Taking the survey twice will allow the research team to test the reliability of the survey. Comparing the SCI-QOL with other legacy measures will allow the investigators to test the validity of the survey.
Additionally, the investigators will be testing the SCI-QOL between Veterans and non-Veterans with SCI to determine if there are differences in their self-reported quality of life.
This study will be recruiting participants at the James J. Peters Veterans Affairs Medical Center (VAMC) in Bronx, New York and the James A. Haley Veterans Affairs (VA) Hospital in Tampa, Florida. The James J. Peters VAMC will be recruiting 125 participants and the James A. Haley VAH will be recruiting 275.
|Condition or disease|
|Spinal Cord Injuries|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Extending Veteran Participation in the Validation of the SCI-QOL/CAT|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
Spinal Cord Injury
Participants with SCI
- Quality of Life Questionnaires [ Time Frame: 2 weeks or up to 7 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238549
|United States, Florida|
|James A. Haley Veterans' Hospital, Tampa, FL|
|Tampa, Florida, United States, 33612|
|United States, New York|
|James J. Peters VA Medical Center, Bronx, NY|
|Bronx, New York, United States, 10468|
|Principal Investigator:||Ann M Spungen, EdD||VA Office of Research and Development|