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

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ClinicalTrials.gov Identifier: NCT01238549
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : November 2, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.


Condition or disease
Spinal Cord Injuries

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Study Type : Observational
Actual Enrollment : 284 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Extending Veteran Participation in the Validation of the SCI-QOL/CAT
Actual Study Start Date : May 1, 2012
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Spinal Cord Injury
Participants with SCI



Primary Outcome Measures :
  1. SCI-QoL Independence [ Time Frame: Baseline ]
    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.


Secondary Outcome Measures :
  1. SCI-QoL Ability to Participate in Social Roles and Activities [ Time Frame: Baseline ]
    Average score on a SCI-QoL Ability to Participate in Social Roles and Activities scale. The minimum score on the scale is 25.1 and the maximum is 61.1. A higher score represents better functioning (more ability to participate in social roles and activities).

  2. SCI-QoL Anxiety [ Time Frame: Baseline ]
    Average score on SCI-QoL Anxiety. The minimum score on the scale is 36.3 and the maximum is 84.2. A higher score represents more anxiety (worse functioning). A lower score represents less anxiety (better functioning).

  3. SCI-QoL Bowel Management Difficulties [ Time Frame: Baseline ]
    Average score on SCI-QoL Bowel Management Difficulties. The minimum score on the scale is 39.2 and the maximum is 76.3. A higher score represents more bowel management difficulties (worse functioning). A lower score represents fewer bowel management difficulties (better functioning).

  4. SCI-QoL Bladder Management Difficulties [ Time Frame: Baseline ]
    Average score on SCI-QoL Bladder Management Difficulties. The minimum score on the scale is 39.7 and the maximum is 76.8. A higher score represents more bladder management difficulties (worse functioning). A lower score represents fewer bladder management difficulties (better functioning).

  5. SCI-QoL Depression [ Time Frame: Baseline ]
    Average score on SCI-QoL Depression. The minimum score on the scale is 38.3 and the maximum is 81.9. A higher score represents more depression (worse functioning). A lower score represents less depression (better functioning).

  6. SCI-QoL Pain Behavior [ Time Frame: Baseline ]
    Average score on SCI-QoL Pain Behavior. The minimum score on the scale is 38.2 and the maximum is 76.1. A higher score represents more pain behavior (worse functioning). A lower score represents less pain behavior (better functioning).

  7. SCI-QoL Pain Interference [ Time Frame: Baseline ]
    Average score on SCI-QoL Pain Interference. The minimum score on the scale is 40.2 and the maximum is 79.7. A higher score represents more pain interference (worse functioning). A lower score represents less anxiety (better functioning).

  8. SCI-QoL Positive Affect and Well-being [ Time Frame: Baseline ]
    Average score on SCI-QoL Positive Affect and Well-being. The minimum score on the scale is 26.7 and the maximum is 68.6. A higher score represents more positive affect and well-being (better functioning).

  9. SCI-QoL Resilience [ Time Frame: Baseline ]
    Average score on SCI-QoL Resilience. The minimum score on the scale is 16.4 and the maximum is 66.4. A higher score represents more resilience (better functioning).

  10. SCI-QoL Satisfaction With Social Roles and Activities [ Time Frame: Baseline ]
    Average score on SCI-QoL Satisfaction with Social Roles and Activities. The minimum score on the scale is 28.3 and the maximum is 60.5. A higher score represents more satisfaction with social roles and activities (better functioning).

  11. SCI-QoL Stigma [ Time Frame: Baseline ]
    Average score on SCI-QoL Stigma. The minimum score on the scale is 37.8 and the maximum is 77.3. A higher score represents more stigma (worse functioning). A lower score represents less stigma (better functioning).

  12. SCI-QoL Trauma [ Time Frame: Baseline ]
    Average score on SCI-QoL Trauma. The minimum score on the scale is 38.4 and the maximum is 85.2. A higher score represents more trauma (worse functioning). A lower score represents less trauma (better functioning).


Other Outcome Measures:
  1. SCI-QoL Grief Loss [ Time Frame: Baseline ]
    Average score on SCI-QoL Grief Loss. The minimum score on the scale is 30.9 and the maximum is 76.1. A higher score represents more grief/loss (worse functioning). A lower score represents less grief/loss (better functioning).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238549


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

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01238549     History of Changes
Other Study ID Numbers: B7566-R
First Posted: November 10, 2010    Key Record Dates
Results First Posted: November 2, 2018
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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