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

NCT ID: NCT01238549

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 284 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-01
• Study Completion Date: 2016-12-31

Brief Summary

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.

Conditions

Spinal Cord Injuries

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Spinal Cord Injury

Participants with SCI

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann M Spungen, EdD

Role: PRINCIPAL_INVESTIGATOR

James J. Peters Veterans Affairs Medical Center

Locations

James A. Haley Veterans' Hospital

Tampa, Florida, United States

James J. Peters VA Medical Center

The Bronx, New York, United States

Countries

United States

Other Identifiers

B7566-R

Identifier Type: -

Identifier Source: org_study_id