Overview

This trial is active, not recruiting.

Condition spinal cord injuries
Treatment arm 1
Sponsor Department of Veterans Affairs
Start date April 2006
End date September 2011
Trial size 249 participants
Trial identifier NCT00117806, B3773-R

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. We 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SCI-VIP: Supported employment implemented for veterans with spinal cord injury
arm 1
SCI-VIP: Supported employment implemented for veterans with spinal cord injury.
(Placebo Comparator)
Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center

Primary Outcomes

Measure
Employment Indices, Employment History, Functional Abilities and Impairments, Quality of Life, Depression.
time frame: 12-month active phase
Competitive Employment-Total Jobs
time frame: 12 months
Competitive Employment-Participants With Competitive Employment
time frame: 12 months
Competitive Employment-Percentage of Participants With Competitive Employment
time frame: 12 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Spinal Cord Injury Vocational Integration Program: Implementation and Outcomes
Principal investigator Lisa Ottomanelli, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.