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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00117806
Recruitment Status : Completed
First Posted : July 8, 2005
Results First Posted : January 1, 2015
Last Update Posted : March 3, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
This study involves research about how to help Veterans with spinal cord injury (SCI) gain employment. During the first couple of years following SCI, many people are concentrating on their rehabilitation and are unable to afford the time for return to work. However, studies have shown people often regain the necessary strength and function about two years after SCI to resume activities of daily living very similar to what they experienced prior to the SCI. Even though many social and legal efforts have been made in the last decade to improve chances for people with disabilities to return to work, Veterans with SCI are sometimes hindered in finding employment because of age, past work history, and many other factors. Other Veterans with SCI are very successful at finding employment either working for themselves or working for a company. The investigators know very little about what issues Veterans with SCI face when they attempt to find employment after SCI. The study will analyze both quantitative and qualitative measures to maximize its findings.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Arm 1 Behavioral: Arm 2 Not Applicable

Detailed Description:

Legal mandates, such as the Rehabilitation Act of 1973 and the Americans with Disabilities Act, have been implemented to improve employment opportunities for disabled persons and yet the proportion of persons with spinal cord injury (SCI) who are employed remains about 9%. For the Veteran population with SCI, the return to work rate is most likely much lower. This study will be conducted to evaluate whether a vocational rehabilitation program patterned after the VA Community Employment and Support approach improves rehabilitation outcomes for the SCI Veteran population as compared with vocational rehabilitation practices currently used in most Veteran Affairs Medical Centers (VAMCs). The vocational rehabilitation program developed for the SCI Veterans is referred to as SCI-VIP and it will be implemented at the Dallas VA Medical Center (VAMC), Houston VAMC, San Diego VAMC, and Cleveland VAMC. A five year evaluative research will be conducted to test the following hypothesized outcomes (HO) from the subjects who participate in the SCI-VIP program and a control group of subjects who receive conventional methods of vocational rehabilitation:

Primary HO: Veterans with SCI who participate in the SCI-VIP will demonstrate significantly greater changes in vocational rehabilitation after twelve months than those who do not receive this intervention. Vocational rehabilitation will be a measure of change from baseline to one-year in the subject's scores on instruments which measure employment indices, perceived barriers to employment, level of handicap, quality of life, depression, and sustaining care needs.

Secondary HO 1: Veterans with SCI who participate in the SCI-VIP will exhibit lower VA and non-VA costs for medical, non-rehabilitation treatment, offsetting the higher SCI-VIP program costs.

Secondary HO 2: The program fidelity will be equally adequate in terms of accomplishing program objectives relative to operations, cost-benefit balance, subject and stakeholder satisfaction, and outcomes when comparing the four SCI-VIP programs and when comparing conventional vocational rehabilitation approaches applied at six different VAMCs.

Program evaluation and cost-benefit analysis will be conducted using a fidelity instrument developed by the researchers and patterned after fidelity instruments conventionally used to evaluate psychiatric rehabilitation programs. Veterans at each VAMC who express an interest in vocational rehabilitation and consent to participate in this study will be randomized to either the experimental or the control group. It is expected that at least 96 subjects will participate in the SCI-VIP approach to vocational rehabilitation and 144 Veterans who receive conventional vocational rehabilitation will form the control group.

Data will be collected from subjects upon enrollment into either the experimental or control group and every three months for one year. Descriptive analysis will be used to compare differences between groups of subjects drawn from each VAMC and to compare participants in the experimental and control groups. Analysis of variance will be computed to determine degree of difference between experimental group and control group subjects' scores on each dependent variable. The study hypotheses will be tested using the Mann-Whitney U, Chi-square, and odds ratio statistical procedures. The Cochran-Mantel-Haenszel along with relative risk scores will indicate the likelihood that any change in performance between baseline and program completion for ether experimental or control group subjects could be attributed to the subjects' degree of participation in the SCI-VIP, which VAMC vocational rehabilitation services were received, SCI factors, and age.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Spinal Cord Injury Vocational Integration Program: Implementation and Outcomes
Study Start Date : April 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm 1
SCI-VIP: Supported employment implemented for veterans with spinal cord injury
Behavioral: Arm 1
SCI-VIP: Supported employment implemented for veterans with spinal cord injury.

Placebo Comparator: Arm 2
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
Behavioral: Arm 2
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center

Primary Outcome Measures :
  1. Competitive Employment-Total Jobs [ Time Frame: 12 months ]
    Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.

  2. Competitive Employment-Participants With Competitive Employment [ Time Frame: 12 months ]
    Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.

  3. Competitive Employment-Percentage of Participants With Competitive Employment [ Time Frame: 12 months ]
    Employment outcomes during year 1 among those subjects obtaining competitive employment.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Between the ages of 18 and 65 years old - Spinal cord injured as a result of trauma or disease
  • Medically and neurologically stable
  • Lives within the metropolitan area that is proximal to the VAMC (Cleveland, Dallas, Houston, San Diego, St. Louis)
  • Has access to transportation
  • Expresses an interest in competitive employment as an outcome of participation
  • Willingly signs a consent form indicating voluntary and informed participation in the study

Exclusion Criteria:

  • Medically and/or surgically unstable
  • Unwilling to complete the consenting process
  • Mentally impaired such that independent reasoning and judgment jeopardize safety of self and others
  • Currently involved in untreated alcohol and/or drug dependency
  • Employed in a compensated job at the time of recruitment and earning above SGA ($940/month in 2008) - Lives more than approximately 100 miles from the participating VAMC SCI Center

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 identifier (NCT number): NCT00117806

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United States, Florida
James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States, 33612
United States, Missouri
VA Medical Center, St Louis
St Louis, Missouri, United States, 63106
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Lisa Ottomanelli, PhD James A. Haley Veterans' Hospital, Tampa, FL
Publications of Results:

Other Publications:
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Responsible Party: VA Office of Research and Development Identifier: NCT00117806    
Other Study ID Numbers: B3773-R
First Posted: July 8, 2005    Key Record Dates
Results First Posted: January 1, 2015
Last Update Posted: March 3, 2016
Last Verified: February 2016
Keywords provided by VA Office of Research and Development:
Employment, supported
Health Service/ut
Quality of life
Veterans/rh (rehabilitation)
Spinal Cord Injuries
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System