Clinical trial NCT01238549: Extending Veteran Participation in the Validation of the SCI-QOL/CAT
Official title: Extending Veteran Participation in the Validation of the SCI-QOL/CAT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injuries
Quality of Life
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-11-10
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans at the James J. Peters Veterans Affairs Medical Center or the James A. Haley Veterans Affairs Hospital with spinal cord injury

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.


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.

Primary outcomes:
measure: SCI-QoL Independence
timeFrame: Baseline
Secondary outcomes:
measure: SCI-QoL Ability to Participate in Social Roles and Activities
timeFrame: Baseline
measure: SCI-QoL Anxiety
timeFrame: Baseline
measure: SCI-QoL Bowel Management Difficulties
timeFrame: Baseline
measure: SCI-QoL Bladder Management Difficulties
timeFrame: Baseline
measure: SCI-QoL Depression
timeFrame: Baseline
measure: SCI-QoL Pain Behavior
timeFrame: Baseline
measure: SCI-QoL Pain Interference
timeFrame: Baseline
measure: SCI-QoL Positive Affect and Well-being
timeFrame: Baseline
measure: SCI-QoL Resilience
timeFrame: Baseline
measure: SCI-QoL Satisfaction With Social Roles and Activities
timeFrame: Baseline
measure: SCI-QoL Stigma
timeFrame: Baseline
measure: SCI-QoL Trauma
timeFrame: Baseline
Other outcomes:
measure: SCI-QoL Grief Loss
timeFrame: Baseline
Locations:
city: Tampa
country: United States
facility: James A. Haley Veterans' Hospital
state: Florida
city: Bronx
country: United States
facility: James J. Peters VA Medical Center
state: New York
Study officials:
affiliation: James J. Peters Veterans Affairs Medical Center
name: Ann M Spungen, EdD
role: PRINCIPAL_INVESTIGATOR
References: