Skip to main content
OpenTrials
Completed

NCT Number: NCT01238549

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

James A. Haley Veterans' Hospital, Tampa, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Nov 10, 2010
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.