NCT00117806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
249

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2005

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 1, 2015

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

5.4 years

First QC Date

July 1, 2005

Results QC Date

October 24, 2014

Last Update Submit

February 3, 2016

Conditions

Spinal Cord Injuries

Keywords

AdultDepressionEmployment, supportedHealth Service/utHumansOutcomesQuality of lifeVeterans/rh (rehabilitation)WorkplaceSpinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

  • Competitive Employment-Total Jobs

    Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.

    12 months

  • Competitive Employment-Participants With Competitive Employment

    Competitive employment (a job in the community paying minimum wage ) during year 1 among those subjects obtaining employment.

    12 months

  • Competitive Employment-Percentage of Participants With Competitive Employment

    Employment outcomes during year 1 among those subjects obtaining competitive employment.

    12 months

Study Arms (2)

Arm 1

EXPERIMENTAL

SCI-VIP: Supported employment implemented for veterans with spinal cord injury

Behavioral: Arm 1

Arm 2

PLACEBO COMPARATOR

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

Behavioral: Arm 2

Interventions

Arm 1BEHAVIORAL

SCI-VIP: Supported employment implemented for veterans with spinal cord injury.

Arm 1
Arm 2BEHAVIORAL

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

Arm 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

James A. Haley Veterans' Hospital, Tampa, FL

Tampa, Florida, 33612, United States

Location

VA Medical Center, St Louis

St Louis, Missouri, 63106, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

Related Publications (12)

  • Ottomanelli L, Goetz LL, McGeough C, Kashner TM. Building research capacity through partnerships: Spinal Cord Injury-Vocational Integration Program Implementations and Outcomes inaugural meeting. J Rehabil Res Dev. 2007;44(1):vii-xii. doi: 10.1682/jrrd.2006.06.0072. No abstract available.

    PMID: 17551852BACKGROUND

  • Ottomanelli L, Lind L. Review of critical factors related to employment after spinal cord injury: implications for research and vocational services. J Spinal Cord Med. 2009;32(5):503-31. doi: 10.1080/10790268.2009.11754553.

    PMID: 20025147BACKGROUND

  • Ottomanelli L, Goetz L, McGeough C, Suris A, Sippel J, Sinnott P, Wagner TH, Cipher DJ. Methods of a multisite randomized clinical trial of supported employment among veterans with spinal cord injury. J Rehabil Res Dev. 2009;46(7):919-30. doi: 10.1682/jrrd.2008.10.0145.

    PMID: 20104414BACKGROUND

  • Thomas FP, Goetz LL, Dixon T, Ho C, Holmes SA, Sandford P, Smith S, Ottomanelli L. Optimizing medical care to facilitate and sustain employment after spinal cord injury. J Rehabil Res Dev. 2014;51(6):xi-xxii. doi: 10.1682/JRRD.2014.05.0119. No abstract available.

    PMID: 25479192BACKGROUND

  • Ottomanelli L, Goetz LL, Suris A, McGeough C, Sinnott PL, Toscano R, Barnett SD, Cipher DJ, Lind LM, Dixon TM, Holmes SA, Kerrigan AJ, Thomas FP. Effectiveness of supported employment for veterans with spinal cord injuries: results from a randomized multisite study. Arch Phys Med Rehabil. 2012 May;93(5):740-7. doi: 10.1016/j.apmr.2012.01.002.

    PMID: 22541306RESULT

  • Ottomanelli L, Barnett SD, Goetz LL. A prospective examination of the impact of a supported employment program and employment on health-related quality of life, handicap, and disability among Veterans with SCI. Qual Life Res. 2013 Oct;22(8):2133-41. doi: 10.1007/s11136-013-0353-5. Epub 2013 Jan 24.

    PMID: 23345022RESULT

  • Ottomanelli L, Barnett SD, Goetz LL. Effectiveness of supported employment for veterans with spinal cord injury: 2-year results. Arch Phys Med Rehabil. 2014 Apr;95(4):784-90. doi: 10.1016/j.apmr.2013.11.012. Epub 2013 Dec 4.

    PMID: 24316325RESULT

  • Sinnott PL, Joyce V, Su P, Ottomanelli L, Goetz LL, Wagner TH. Cost-effectiveness of supported employment for veterans with spinal cord injuries. Arch Phys Med Rehabil. 2014 Jul;95(7):1254-61. doi: 10.1016/j.apmr.2014.01.010. Epub 2014 Jan 31.

    PMID: 24486426RESULT

  • Smith-Morris C, Lopez G, Ottomanelli L, Goetz L, Dixon-Lawson K. Ethnography, fidelity, and the evidence that anthropology adds: supplementing the fidelity process in a clinical trial of supported employment. Med Anthropol Q. 2014 Jun;28(2):141-61. doi: 10.1111/maq.12093. Epub 2014 Apr 21.

    PMID: 24752942RESULT

  • Ottomanelli L, Barnett SD, Toscano R. Individual placement and support (IPS) in physical rehabilitation and medicine: the VA spinal cord injury experience. Psychiatr Rehabil J. 2014 Jun;37(2):110-2. doi: 10.1037/prj0000079.

    PMID: 24912059RESULT

  • LePage J, Ottomanelli L, Barnett SD, Njoh EN. Spinal cord injury combined with felony history: effect on supported employment for Veterans. J Rehabil Res Dev. 2014;51(10):1497-504. doi: 10.1682/JRRD.2014.02.0045.

    PMID: 25856266RESULT

  • Ottomanelli L, Barnett SD, Goetz LL, Toscano R. Vocational rehabilitation in spinal cord injury: what vocational service activities are associated with employment program outcome? Top Spinal Cord Inj Rehabil. 2015 Winter;21(1):31-9. doi: 10.1310/sci2101-31.

    PMID: 25762858RESULT

MeSH Terms

Conditions

Spinal Cord InjuriesDepression

Interventions

DMAC2L protein, human

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBehavioral SymptomsBehavior

Limitations and Caveats

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)

Results Point of Contact

Title
Lisa Ottomanelli, PhD
Organization
James A. Haley Veterans' Hospital
lisa.ottomanelli@va.gov
813-558-3917

Study Officials

  • Lisa Ottomanelli, PhD

    James A. Haley Veterans' Hospital, Tampa, FL

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2005

First Posted

July 8, 2005

Study Start

April 1, 2006

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 3, 2016

Results First Posted

January 1, 2015

Record last verified: 2016-02

Locations

US(5)