Extending Veteran Participation in the Validation of the SCI-QOL/CAT

VA Office of Research and Development

Status: Completed

Conditions: Spinal Cord Injuries

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT01238549

B7566-R

Details and patient eligibility

About

The field of spinal cord injury 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 spinal cord injury-specific, quality of life survey tool in non-Veterans with spinal cord injury called the spinal cord injury-quality of life (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, Bronx, New York and the James A. Haley Veterans Affairs Hospital, Tampa, Florida.

Enrollment: 284 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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 spinal cord injury ("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.

Trial design

284 participants in 1 patient group

Spinal Cord Injury

Description:

Participants with SCI