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Spinal Cord Injury Vocational Integration Program (SCI-VIP) (SCI-VIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00117806
First received: July 1, 2005
Last updated: February 3, 2016
Last verified: February 2016
Results First Received: October 24, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Spinal Cord Injuries
Interventions: Behavioral: Arm 1
Behavioral: Arm 2

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two-hundred forty-nine subjects were enrolled in the study which, 48 were excluded for various reasons including benefits (n=19), age >65 (n=10), currently employed (n=6), and other (n=13), leaving 201 subjects. For the purposes of reporting the 44 veterans in the observational site were not included, therefore there are only 157 subjects included.

Reporting Groups
  Description
Supported Employment

SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury

Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury.

Treatment As Usual Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center

Participant Flow:   Overall Study
    Supported Employment   Treatment As Usual
STARTED   81   76 
COMPLETED   43   60 
NOT COMPLETED   38   16 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

AIS DATA-Missing 1 participant for Supported Employment and Treatment As Usual groups.

AIS & Neurologival Level- Missing 1 participant for Supported employment.


Reporting Groups
  Description
Supported Employment

SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury

Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury.

Treatment As Usual Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
Total Total of all reporting groups

Baseline Measures
   Supported Employment   Treatment As Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 81   76   157 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   81   76   157 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.7  (9.8)   49.8  (9.8)   49.2  (9.8) 
Gender 
[Units: Participants]
     
Female   4   4   8 
Male   77   72   149 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   37   33   70 
African American   29   37   66 
Hispanic   5   1   6 
Other   10   5   15 
Functional Independence Measure [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Total   98.9  (23.8)   98.2  (23.7)   98.6  (23.6) 
Cognitive   33.8  (2.3)   33.7  (2.8)   33.8  (2.5) 
Motor   66.9  (21.6)   66.4  (22.2)   66.6  (21.8) 
[1] The FIM is an 18-item instrument that assesses disability in terms of what level of assistance an individual needs to perform various activities. Each item is on a scale from 1 (total assistance) to 7 (complete independence). Motor subscale scores range from 13 (total dependence) to 91 (total independence) and cognitive subscale scores range from 5 (total dependence) to 35 (total independence). Motor and Cognitive are summed to create the Total FIM scores which range from 18 (totally dependent) to 126 (totally independent).
Measures of Handicap (CHART) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Social Integration   82.0  (13.6)   84.7  (12.7)   83.3  (13.1) 
Mobility   80.4  (17.0)   80.4  (22.4)   80.4  (19.7) 
Cognitive   89.4  (16.6)   90.8  (14.9)   90.1  (15.7) 
Occupation   51.5  (32.9)   50.4  (30.6)   51.0  (31.7) 
Physical   85.7  (20.9)   87.2  (22.1)   86.4  (21.4) 
Economic Self Sufficiency   51.5  (37.8)   52.6  (36.9)   52.1  (15.7) 
[1] The CHART contains 32 items assessing six dimensions of a person’s handicap: cognitive independence, physical independence, mobility, occupation, social integration, and economic self-sufficiency. A minimum score of 0 indicating full handicap in an individual's ability to sustain an individual existence and maximum score of 100 indicating no handicap in an individual's ability to sustain an individual existence , is permitted for each subscale.
Quality of Life VR-36 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Mental Component Score   54.7  (13.8)   55.6  (12.9)   55.1  (13.3) 
Physical Component Score   27.7  (7.5)   28.1  (8.4)   27.9  (7.9) 
[1] The VR-36 is a 36-item instrument which assesses general health-related quality of life. The VR-36 assesses eight domains of a person’s health and functioning: physical functioning, role limitations due to physical problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. The item responses are on a 3-point scale ranging from "Yes, limited a lot" to "No, not limited at all." The items are summed and the range is from 0-100, 100 is equivalent to maximum health.
ASIA Impairment Scale (AIS) [1] 
[Units: Participants]
     
A-Complete   26   20   46 
B-Sensory Incomplete   11   13   24 
C-Motor Incomplete   18   18   36 
D-Motor Incomplete   25   21   46 
E-Normal   0   4   4 
[1]

The ASIA Impairment Scale is a tool used to categorize motor & sensory impairment in individuals with SCI. A-Comp B-Incomp: Sensory but not motor function is preserved below the neurological level & includes the sacral segments S4-S5. C-Incomplete: Motor function is preserved below the neuro level & more than half of key muscles below the neuro level have a muscle grade < 3. D-Incomplete: Motor function is preserved below the neuro level, and at least half of key muscles below the neuro level have a muscle grade of >=3; E-Normal.

Data were not available for all participants. Incomplete data.

AIS and neurological Level [1] 
[Units: Participants]
     
High tetraplegia, AIS A, B,C   12   13   25 
Low tetraplegia, AIS A, B, C   5   10   15 
Paraplegia, AIS A, B, C   38   27   65 
AIS D/E   25   25   50 
[1] Data were not available for all participants.
Marital Status 
[Units: Participants]
     
Married   30   15   45 
Divorced   28   34   62 
Other   23   27   50 
Education Years 
[Units: Years]
Mean (Standard Deviation)
 13.1  (2.3)   13.5  (1.9)   13.3  (2.2) 
VA benefits recipient [1] 
[Units: Participants]
 50   43   93 
[1] Data were not available for all participants. Not all veterans were recipients of VA benefits.
Service-connected benefits for SCI recipient [1] 
[Units: Participants]
 19   15   34 
[1] Data were not available for all participants. Not all veterans received service-connected benefits.
Service-connected 100% [1] 
[Units: Participants]
 16   13   29 
[1] Data were not available for all participants. Not all veterans were 100% service-connected.
No Service-connected/Non-service-connected benefits [1] 
[Units: Participants]
 26   20   46 
[1] Data were not available for all participants. Not all veterans received service-connected or non-service connected benefits.
Non-service-connected pension [1] 
[Units: Participants]
 18   18   36 
[1] Data were not available for all participants. Not all veterans received non-service-connected benefits.
Monthly non-service-connected amount 
[Units: Dollars]
Mean (Standard Deviation)
 1024  (482)   986  (421)   1005.7  (447.9) 
Social Security Income recipient [1] 
[Units: Participants]
 10   11   21 
[1] Data were not available for all participants. Not all veterans received SSI.
Social Security Disability Insurance recipient [1] 
[Units: Participants]
 45   46   91 
[1] Data were not available for all participants. Not all veterans were recipients of SSDI.
Neither Social Security Income/Social Security Disability Insurance recipient [1] 
[Units: Participants]
 26   20   46 
[1] Data were not available for all participants. Some veterans were neither recipients of SSI & SSDI.


  Outcome Measures
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1.  Primary:   Competitive Employment-Total Jobs   [ Time Frame: 12 months ]

2.  Primary:   Competitive Employment-Participants With Competitive Employment   [ Time Frame: 12 months ]

3.  Primary:   Competitive Employment-Percentage of Participants With Competitive Employment   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Majority of sample is male; Potential selection bias (participants who decided to remain in study for second year may be different from those who did not though no statistical significance was detected between groups)


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Lisa Ottomanelli, PhD
Organization: James A. Haley Veterans' Hospital
phone: 813-558-3917
e-mail: lisa.ottomanelli@va.gov


Publications of Results:

Other Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00117806     History of Changes
Other Study ID Numbers: B3773-R
Study First Received: July 1, 2005
Results First Received: October 24, 2014
Last Updated: February 3, 2016
Health Authority: United States: Federal Government