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. Identifier: NCT01238549
Recruitment Status : Active, not recruiting
First Posted : November 10, 2010
Last Update Posted : August 18, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Spinal Cord Injury
Participants with SCI

Primary Outcome Measures :
  1. Quality of Life Questionnaires [ Time Frame: 2 weeks or up to 7 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Veterans at the James J. Peters VAMC or the James A. Haley VA Hospital with spinal cord injury

Inclusion Criteria:

  • Male and female Veterans with traumatic spinal cord injury
  • At least 18 years old
  • Persons judged by their primary care doctor to be competent
  • Able to read
  • Fluent in English.

Exclusion Criteria:

  • Veterans with non-traumatic SCI ("non-traumatic" is defined as any injury from a chronic condition that resulted in decline of function due to the paralysis. These conditions include, but are not limited to: multiple sclerosis, arteriole-venous malformation, nerve impingement syndromes, congenital birth defects, or other)
  • Diagnosis of a cognitive impairment (in the clinical chart) such that it limit the subject's ability to read, understand, and respond to statements about quality of life
  • Not fluent in English.

Information from the National Library of Medicine

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 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
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Ann M Spungen, EdD VA Office of Research and Development

Responsible Party: VA Office of Research and Development Identifier: NCT01238549     History of Changes
Other Study ID Numbers: B7566-R
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: August 18, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
Spinal Cord Injuries
Quality of Life

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System