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Extending Veteran Participation in the Validation of the Spinal Cord Injury-Quality Of Life/Computerized Adaptive Test (SCI-QOL/CAT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01238549
First received: November 8, 2010
Last updated: August 17, 2016
Last verified: August 2016
  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 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 (VAMC) in Bronx, New York and the James A. Haley Veterans Affairs (VA) Hospital in Tampa, Florida. The James J. Peters VAMC will be recruiting 125 participants and the James A. Haley VAH will be recruiting 275.


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

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spinal Cord Injury
Participants with SCI

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Veterans at the James J. Peters VAMC or the James A. Haley VA Hospital with spinal cord injury
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238549

Locations
United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
United States, New York
James J. Peters VA Medical Center, Bronx, NY
Bronx, New York, United States, 10468
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Ann M Spungen, EdD VA Office of Research and Development
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01238549     History of Changes
Other Study ID Numbers: B7566-R 
Study First Received: November 8, 2010
Last Updated: August 17, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by VA Office of Research and Development:
Spinal Cord Injuries
Quality of Life

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on September 27, 2016