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Not yet recruitingNCT05508802Updated Aug 19, 2022

Interventional Cooperative Agreement Program - Vocational Intervention Demonstration

An interventional study of State Counselor-Coordinated Services and Center Facilitator-Coordinated Services in Spinal Cord Injuries, Brain Injuries and Employment, sponsored by Kessler Foundation. Not yet recruiting. Open to participants aged 18 Years to 62 Years. Per ClinicalTrials.gov, last updated 2022-08-19.

Sponsored by Kessler Foundation · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
18 Years to 62 Years
Sex
All
01

Study summary

For many people with spinal cord injury or brain injury, seeking employment after injury is an important goal. There are services available to help people with disabilities. However, the best ways to coordinate and deliver these services are not yet known. This project will compare two ways of coordinating and delivering services that are designed to help people with spinal cord injury or brain injury obtain employment.

Read the detailed description

Employment is important for financial security, social connection, and life satisfaction. Unfortunately, rates of unemployment remain high among people with spinal cord injury (SCI) and brain injury (BI). To help address this challenge, the investigators are conducting a single-site, randomized, controlled trial to compare two programs intended to increase rates of employment among people with SCI or BI. In one program, services are coordinated by a counselor employed by the New Jersey State Division of Vocational Rehabilitation Services, a state-based agency that assists people with disabilities who are interested in pursuing employment. In the other program, services are coordinated by a facilitator who is employed by the rehabilitation hospital at which the participant receives inpatient care. Services provided in both programs will be customized to the participant's needs and goals. Services will begin in inpatient rehabilitation and may include education, therapy, equipment provision, counseling, and other interventions.

The project will enroll 500 participants who are interested in becoming employed or returning to work. Information about employment status, earnings, benefits use, community participation, and health will be collected through a combination of surveys, medical record review, and information available in state and federal administrative databases. Analyses will examine the rate of participants employed at 1 year after enrollment in each group, time to employment, earnings, benefits usage, community participation, and well-being. Findings from this study will be used to determine which ways of delivering services are most effective in enabling employment, and to provide information to help other rehabilitation centers adopt effective programs.

02

Conditions studied

  • Spinal Cord Injuries
  • Brain Injuries
  • Employment
  • Spinal Cord Diseases

Keywords

  • employment
  • vocational rehabilitation
03

In context

Spinal Cord Injuries

1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.

This study's planned enrollment of 500 is above the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 174 studies on the registry; 60 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 62 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Adults aged 18-62
  • New Jersey resident
  • Admitted to Kessler Institute for Rehabilitation (KIR) due to a spinal cord injury (SCI) or brain injury (BI)
  • Receiving inpatient rehabilitation at KIR
  • Community living in the state of New Jersey after discharge from KIR
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
500 participants (estimated)

Study arms

  • Other
    State Counselor-Coordinated Services

    In this program, services are coordinated by a counselor employed by the New Jersey State Division of Vocational Rehabilitation Services (NJDVRS), a state-based agency that assists people with disabilities who are interested in pursuing employment. While the participant is in inpatient rehabilitation or soon after their discharge, a member of the research team will assist them in completing the necessary documentation to apply for services from this agency. Services for which they are eligible will be provided directly through NJDVRS.

    Other: State Counselor-Coordinated Services

  • Other
    Center Facilitator-Coordinated Services

    In this program, services are coordinated by a facilitator who is employed by Kessler Institute for Rehabilitation and works cooperatively with NJDVRS. The facilitator will begin working with the participant during inpatient rehabilitation, or soon after discharge, depending on when they enroll in the study. Some services for which they are eligible will be provided through NJDVRS and others will be provided to them by the facilitator.

    Other: Center Facilitator-Coordinated Services

Interventions

  • OtherState Counselor-Coordinated Services

    A counselor affiliated with the New Jersey State Division of Vocational Rehabilitation Services coordinates services that consider the participant's condition, needs and goals. Services they may receive include: * Education on programs designed to help people with spinal cord injury or brain injury pursue employment. * Advice and guidance from professional counselors who have special training in helping people with disabilities pursue employment. * Help completing applications for services. * Assistance communicating with my employer about my needs and ways to accommodate them. * Referrals to and services from other health care or technology providers.

  • OtherCenter Facilitator-Coordinated Services

    A facilitator affiliated with Kessler Institute for Rehabilitation coordinates services that consider the participant's condition, needs and goals. Services they may receive include: * Education on programs designed to help people with spinal cord injury or brain injury pursue employment. * Advice and guidance from professional counselors who have special training in helping people with disabilities pursue employment. * Help completing applications for services. * Assistance communicating with my employer about my needs and ways to accommodate them. * Referrals to and services from other health care or technology providers.

06

What researchers measure

Primary outcomes

  1. Employment Status

    Proportion of participants in each group in competitive employment

    Time frame: 12-months post-enrollment

Secondary outcomes

  1. Earnings

    Earnings within the first 12 months post-enrollment as obtained from New Jersey Unemployment Insurance (UI) data

    Time frame: 12-months post-enrollment

  2. SSI and SSDI Benefit Applications

    Proportion of participants who report via survey that they applied for Supplemental Security Income (SSI) and Social Security Disability Insurance (SSDI) benefits

    Time frame: 12-months post-enrollment

  3. SSI and SSDI Benefit Awards

    Proportion of participants who report via survey that they were awarded SSI and SSDI benefits

    Time frame: 12-months post-enrollment

  4. Job Satisfaction

    Survey to assess job satisfaction and attitudes toward work

    Time frame: 12-months post-enrollment

  5. Satisfaction with Services

    Survey to assess satisfaction with services provided

    Time frame: 12-months post-enrollment

  6. Self-Reported Health and Well-Being

    Survey to assess emotional well-being, current general health status, and extent to which current health limits ability to work

    Time frame: 12-months post-enrollment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2022; primary completion for Sep 2026, 47 months later.

Of 766 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 47 months is above that.

Counting every sponsor, half of 816 studies reached it within 35 months; a quarter within 16 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2022
First posted
Aug 19, 2022
StartEst.
Oct 1, 2022
Primary completionEst.
Sep 29, 2026
CompletionEst.
Oct 2026
Last update
Aug 19, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05508802
Lead sponsor
Kessler Foundation
Collaborators
Mathematica Policy Research, Inc.
Responsible party
Sponsor
First posted
Aug 19, 2022
Start date
Oct 1, 2022 (estimated)
Primary completion
Sep 29, 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Aug 19, 2022

Study contacts

John O'Neill, Ph.D.
Contact
joneill@kesslerfoundation.org
973-324-8387

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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