Spinal Cord InjuriesNCT05508802
Interventional Cooperative Agreement Program - Vocational Intervention Demonstration
A study testing State Counselor-Coordinated Services and Center Facilitator-Coordinated Services in people with Spinal Cord Injuries and Brain Injuries, run by Kessler Foundation.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 62 years
- Conditions the study is for
- Spinal Cord Injuries, Brain Injuries, Employment
- What is being tested?
- State Counselor-Coordinated Services and Center Facilitator-Coordinated Services
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 62 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Spinal Cord Injuries, Brain Injuries, Employment, Spinal Cord Diseases
- Being tested
- State Counselor-Coordinated Services, Center Facilitator-Coordinated Services
- Keywords
- employment, vocational rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Brain Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State Counselor-Coordinated ServicesOther
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.
Center Facilitator-Coordinated ServicesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| State Counselor-Coordinated Services | Other | 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. Receives: Other: State Counselor-Coordinated Services |
| Center Facilitator-Coordinated Services | Other | 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. Receives: Other: Center Facilitator-Coordinated Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employment Status
Proportion of participants in each group in competitive employment
Measured: 12-months post-enrollment
Secondary outcomes (6)
Earnings
Earnings within the first 12 months post-enrollment as obtained from New Jersey Unemployment Insurance (UI) data
Measured: 12-months post-enrollment
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
Measured: 12-months post-enrollment
SSI and SSDI Benefit Awards
Proportion of participants who report via survey that they were awarded SSI and SSDI benefits
Measured: 12-months post-enrollment
Job Satisfaction
Survey to assess job satisfaction and attitudes toward work
Measured: 12-months post-enrollment
Satisfaction with Services
Survey to assess satisfaction with services provided
Measured: 12-months post-enrollment
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
Measured: 12-months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Oct 2022 (estimated)
- Primary completion29 Sep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Mathematica Policy Research, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508802
- Sponsor's protocol ID
- L-1171-21B
- Status last verified
- Aug 2022
- First submitted
- 19 Jan 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Cooperative Agreement Program - Vocational Intervention Demonstration
- ClinicalTrials.gov ID
- NCT05508802
- Acronym / sponsor ID
- L-1171-21B
- Conditions
- Spinal Cord Injuries, Brain Injuries, Employment, Spinal Cord Diseases
- Keywords
- employment, vocational rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Mathematica Policy Research, Inc.
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 29 Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| State Counselor-Coordinated Services | Other | Other: State Counselor-Coordinated ServicesIn 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. |
| Center Facilitator-Coordinated Services | Other | Other: Center Facilitator-Coordinated ServicesIn 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. |
Who may qualify
- Ages
- 18 to 62 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| State Counselor-Coordinated ServicesA 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. | Other | State Counselor-Coordinated Services |
| Center Facilitator-Coordinated ServicesA 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. | Other | Center Facilitator-Coordinated Services |
Primary outcome
Employment Status
Time frame: 12-months post-enrollment
Proportion of participants in each group in competitive employment
6 secondary outcomes
Earnings
Time frame: 12-months post-enrollment
SSI and SSDI Benefit Applications
Time frame: 12-months post-enrollment
SSI and SSDI Benefit Awards
Time frame: 12-months post-enrollment
Job Satisfaction
Time frame: 12-months post-enrollment
Satisfaction with Services
Time frame: 12-months post-enrollment
Self-Reported Health and Well-Being
Time frame: 12-months post-enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing State Counselor-Coordinated Services and Center Facilitator-Coordinated Services in people with Spinal Cord Injuries and Brain Injuries, run by Kessler Foundation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John O'Neill, Ph.D. (973-324-8387, joneill@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Employment Status (time frame: 12-months post-enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.