Extending Veteran Participation in the Validation of the Spinal Cord Injury-Quality Of Life/Computerized Adaptive Test (SCI-QOL/CAT)
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Purpose
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 our 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. Each site will be recruiting 200 participants.
| Condition |
|---|
|
Spinal Cord Injuries |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Extending Veteran Participation in the Validation of the SCI-QOL/CAT |
- Quality of Life Questionnaires [ Time Frame: 2 weeks or up to 7 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Group 1
Veterans with traumatic spinal cord injury
|
Eligibility| Ages Eligible for Study: | 18 Years to 89 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Contacts and Locations| Contact: Kel G Morin | (718) 584-9000 ext 5129 | Kel.Morin@va.gov |
| United States, Florida | |
| James A. Haley Veterans' Hospital, Tampa, FL | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Barbara McKenzie, MA 813-558-3914 Barbara.McKenzie@VA.GOV | |
| United States, New York | |
| VA Medical Center, Bronx | Recruiting |
| Bronx, New York, United States, 10468 | |
| Contact: Kel G Morin 718-584-9000 ext 5129 Kel.Morin@va.gov | |
| Principal Investigator: Ann M. Spungen, EdD | |
| Principal Investigator: | Ann M. Spungen, EdD | VA Medical Center, Bronx |
More Information
No publications provided
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01238549 History of Changes |
| Other Study ID Numbers: | B7566-R |
| Study First Received: | November 8, 2010 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Spinal Cord Injuries Quality of Life |
Additional relevant MeSH terms:
|
Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013