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

NCT01238549 | Completed Results

• 1 other identifier: B7566-R
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 2

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

Keywords

Spinal Cord Injuries; Quality of Life

Outcome Measures

Primary Outcomes (1)

• SCI-QoL Independence

  Average score on a questionnaire about level of independence. The minimum score on the scale is 24.6 and the maximum is 68.9. Fifty is the average score. Values below 50 indicate a worse outcome. Values above 50 represent a better outcome.

  Baseline

Secondary Outcomes (12)

• SCI-QoL Ability to Participate in Social Roles and Activities

  Baseline

• SCI-QoL Anxiety

  Baseline

• SCI-QoL Bowel Management Difficulties

  Baseline

• SCI-QoL Bladder Management Difficulties

  Baseline

• SCI-QoL Depression

  Baseline

Other Outcomes (1)

• SCI-QoL Grief Loss

  Baseline

Study Arms (1)

Spinal Cord Injury

Participants with SCI

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

James A. Haley Veterans' Hospital

Tampa, Florida, 33612, United States

Location

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

This study was designed to determine validity and reliability of the SCI QOL in Veterans with SCI. It was not designed to determine their quality of life.

Results Point of Contact

• Title: Dr. Ann Spungen
• Organization: VAORD

ann.spungen@va.gov

718-584-9000

Study Officials

• Ann M Spungen, EdD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 10, 2010
• Study Start: May 1, 2012
• Primary Completion: December 31, 2015
• Study Completion: December 31, 2016
• Last Updated: November 29, 2018
• Results First Posted: November 2, 2018

Record last verified: 2018-11

Locations

US (2)