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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Spinal Cord Injuries
Enrollment 284
Recruitment Details

Participants recruited from SCI Clinics at the James J. Peters Veterans Affairs Medical Center, Bronx, New York and the James A. Haley Veterans Hospital, Tampa, Florida.

284 participants signed consent. 248 participants completed the Quality of Life questionnaires.

Pre-assignment Details  
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description Participants with SCI
Period Title: Overall Study
Started 284
Completed 248
Not Completed 36
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description Participants with SCI
Overall Number of Baseline Participants 248
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants
<=18 years
0
   0.0%
Between 18 and 65 years
185
  74.6%
>=65 years
63
  25.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 248 participants
56.98  (12.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants
Female
12
   4.8%
Male
236
  95.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants
Hispanic or Latino
23
   9.3%
Not Hispanic or Latino
218
  87.9%
Unknown or Not Reported
7
   2.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 248 participants
American Indian or Alaska Native
2
   0.8%
Asian
2
   0.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
50
  20.2%
White
168
  67.7%
More than one race
3
   1.2%
Unknown or Not Reported
23
   9.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 248 participants
248
 100.0%
1.Primary Outcome
Title SCI-QoL Independence
Hide Description 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.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not completed item bank or outcomes.
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 247
Mean (Standard Deviation)
Unit of Measure: units on a scale
49.9  (10.2)
2.Secondary Outcome
Title SCI-QoL Ability to Participate in Social Roles and Activities
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not completed item bank or outcomes.
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 247
Mean (Standard Deviation)
Unit of Measure: units on a scale
45.5  (8.0)
3.Secondary Outcome
Title SCI-QoL Anxiety
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: units on a scale
48.3  (10.2)
4.Secondary Outcome
Title SCI-QoL Bowel Management Difficulties
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: units on a scale
47.5  (9.8)
5.Secondary Outcome
Title SCI-QoL Bladder Management Difficulties
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: units on a scale
50.5  (9.6)
6.Secondary Outcome
Title SCI-QoL Depression
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not completed item bank or outcomes.
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 247
Mean (Standard Deviation)
Unit of Measure: units on a scale
47.7  (9.9)
7.Secondary Outcome
Title SCI-QoL Pain Behavior
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: units on a scale
53.7  (9.5)
8.Secondary Outcome
Title SCI-QoL Pain Interference
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
One participant did not completed item bank or outcomes.
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 247
Mean (Standard Deviation)
Unit of Measure: units on a scale
54.8  (10.2)
9.Secondary Outcome
Title SCI-QoL Positive Affect and Well-being
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: units on a scale
55.7  (9.0)
10.Secondary Outcome
Title SCI-QoL Resilience
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: units on a scale
53.9  (11.6)
11.Secondary Outcome
Title SCI-QoL Satisfaction With Social Roles and Activities
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: units on a scale
47.5  (6.9)
12.Secondary Outcome
Title SCI-QoL Stigma
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: units on a scale
50.9  (7.9)
13.Secondary Outcome
Title SCI-QoL Trauma
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: units on a scale
46.8  (10.3)
14.Other Pre-specified Outcome
Title SCI-QoL Grief Loss
Hide Description 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).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description:
Participants with SCI
Overall Number of Participants Analyzed 248
Mean (Standard Deviation)
Unit of Measure: units on a scale
46.5  (11.0)
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Spinal Cord Injury
Hide Arm/Group Description Participants with SCI
All-Cause Mortality
Spinal Cord Injury
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Spinal Cord Injury
Affected / at Risk (%)
Total   0/248 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Spinal Cord Injury
Affected / at Risk (%)
Total   0/248 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ann Spungen
Organization: VAORD
Phone: 718-584-9000 ext 5814
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01238549     History of Changes
Other Study ID Numbers: B7566-R
First Submitted: November 8, 2010
First Posted: November 10, 2010
Results First Submitted: December 1, 2016
Results First Posted: November 2, 2018
Last Update Posted: November 29, 2018