Spinal Cord Injury Vocational Integration Program (SCI-VIP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00117806
First received: July 1, 2005
Last updated: February 5, 2015
Last verified: February 2015
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
Intervention: Behavioral: Arm 1

  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  
Number of Participants  
[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)  
Measures of Handicap (CHART) [2]
[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)  
Quality of Life VR-36 [3]
[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)  
ASIA Impairment Scale (AIS) [4]
[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  
AIS and neurological Level [5]
[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  
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 [6]
[units: participants]
  50     43     93  
Service-connected benefits for SCI recipient [7]
[units: participants]
  19     15     34  
Service-connected 100% [8]
[units: participants]
  16     13     29  
No Service-connected/Non-service-connected benefits [9]
[units: participants]
  26     20     46  
Non-service-connected pension [10]
[units: participants]
  18     18     36  
Monthly non-service-connected amount  
[units: dollars]
Mean (Standard Deviation)
  1024  (482)     986  (421)     1005.7  (447.9)  
Social Security Income recipient [11]
[units: participants]
  10     11     21  
Social Security Disability Insurance recipient [12]
[units: participants]
  45     46     91  
Neither Social Security Income/Social Security Disability Insurance recipient [13]
[units: participants]
  26     20     46  
[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).
[2] 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.
[3] 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.
[4]

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.

[5] Data were not available for all participants.
[6] Data were not available for all participants. Not all veterans were recipients of VA benefits.
[7] Data were not available for all participants. Not all veterans received service-connected benefits.
[8] Data were not available for all participants. Not all veterans were 100% service-connected.
[9] Data were not available for all participants. Not all veterans received service-connected or non-service connected benefits.
[10] Data were not available for all participants. Not all veterans received non-service-connected benefits.
[11] Data were not available for all participants. Not all veterans received SSI.
[12] Data were not available for all participants. Not all veterans were recipients of SSDI.
[13] 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 ]

4.  Primary:   Employment Indices, Employment History, Functional Abilities and Impairments, Quality of Life, Depression.   [ Time Frame: 12-month active phase ]
Results not yet reported.   Anticipated Reporting Date:   11/2014   Safety Issue:   No


  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 ext n/a
e-mail: lisa.ottomanelli@va.gov


Publications of Results:
Other Publications:
Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
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 5, 2015
Health Authority: United States: Federal Government