Spinal Cord InjuriesNCT05506657
Early Intervention to Promote Return to Work for People With Spinal Cord Injury
A study testing State Counselor-Coordinated Services and Center Facilitator-Coordinated Services in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Kessler Foundation.
Trial summary
For many people with spinal cord 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, Spinal Cord Diseases
- 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
- 162 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2022to 31 Aug 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 age 18 to 62
- a neurological impairment secondary to an SCI that occurred less than 12 months prior to enrollment
- receiving inpatient rehabilitation at Kessler Institute for Rehabilitation (KIR)
- community living in the state of NJ after discharge from KIR
- have a goal to pursue competitive integrated employment or education/retraining leading to competitive integrated employment
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
For many people with spinal cord 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 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). To help address this challenge, the Northern New Jersey Spinal Cord Injury System (NNJSCIS) is conducting a single-site, randomized, controlled trial to compare two programs intended to increase rates of employment among people with SCI. The project will enroll 162 recently injured adults with SCI who are interested in becoming employed or returning to work and will compare different ways of delivering employment-related services in the first year after injury. Services will begin in inpatient rehabilitation and may include education, therapy, equipment provision, counseling, and other interventions. Information about employment status, earnings, community participation, and health will be collected through a combination of questionnaires and databases. Participants and service providers will also share their impressions of the programs via survey and focus groups. Analyses will examine the rate of participants employed at 1 year in each group, time to employment, earnings, community participation, and other aspects of well-being. Findings from this study will be used to determine which ways of delivering services are most effective in enabling employment by 1 year after injury, and to provide information to help other rehabilitation centers adopt effective programs.
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Being tested
- State Counselor-Coordinated Services, Center Facilitator-Coordinated Services
- Keywords
- employment, vocational rehabilitation
- Medical subject headings
- Spinal Cord 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 participants 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 participants 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 (Percent Employed)
Proportion of participants in each group in competitive employment.
Measured: 12-months post-enrollment
Secondary outcomes (10)
Employment Efficiency (Median Time to Employment)
Median number of months from date of enrollment to date of competitive integrated employment; obtained through self-report.
Measured: 12-months post-enrollment
Income
Earnings within the first 12 months post-enrollment as obtained from New Jersey Unemployment Insurance (UI) data.
Measured: 12-months post-enrollment
Satisfaction with Life Scale (SWLS)
5 item (2 minute) scale that provides global measure of life satisfaction.
Measured: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
International SCI Quality of Life Basic Data Set
3 item (~1 minute) assessment of satisfaction with life as a whole, physical health, psychological health.
Measured: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Craig Handicap Assessment and Reporting Technique (CHART)
Subscales examine several objective physical independence, cognitive independence, mobility, occupation, social integration, and economic self-sufficiency; includes personal care assistance use.
Measured: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Spinal Cord Injury Quality of Life: Satisfaction with Social Roles and Activities (SCI-QoL)
10 item short form (<5 minutes) examining extent of satisfaction or disappointment with social roles and activities; complements CHART.
Measured: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Patient Health Questionnaire (PHQ-9)
Measure of depressive symptomology (9 items; 3 minutes).
Measured: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Spinal Cord Injury Quality of Life: Self-Esteem
8 item (<5 minute) short form; assesses emotional, evaluative, and cognitive perceptions of personal competence and worth.
Measured: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Spinal Cord Injury Quality of Life: Independence
8 item (<5 minute) short form.
Measured: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Exit Survey
Includes rating scale and open-ended items pertaining to satisfaction with the program and suggestions for optimization of the programs.
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 posted18 Aug 2022
- Study start30 Sep 2022 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion31 Aug 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trevor Dyson-Hudson, M.D., Principal investigator, Kessler FoundationJohn O'Neill, Ph.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506657
- Sponsor's protocol ID
- L-1171-21A
- Status last verified
- Aug 2022
- First submitted
- 19 Jan 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD), except if/when limited by data use agreements established with the New Jersey Department of Labor, will be shared via the Interuniversity Consortium for Political and Social Research (ICPSR), the preferred data repository for the National Institute on Disability, Independent Living, and Rehabilitation Research. Data shared via ICPSR will include data from measures collected at baseline and follow-ups for purposes of sample characterization and/or outcomes assessment. All data will be de-identified and labeled with subject identification numbers established for the study rather than names or initials.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention to Promote Return to Work for People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05506657
- Acronym / sponsor ID
- L-1171-21A
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases
- Keywords
- employment, vocational rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 30 Sep 2022 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 18 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, 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 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). To help address this challenge, the Northern New Jersey Spinal Cord Injury System (NNJSCIS) is conducting a single-site, randomized, controlled trial to compare two programs intended to increase rates of employment among people with SCI. The project will enroll 162 recently injured adults with SCI who are interested in becoming employed or returning to work and will compare different ways of delivering employment-related services in the first year after injury. Services will begin in inpatient rehabilitation and may include education, therapy, equipment provision, counseling, and other interventions. Information about employment status, earnings, community participation, and health will be collected through a combination of questionnaires and databases. Participants and service providers will also share their impressions of the programs via survey and focus groups. Analyses will examine the rate of participants employed at 1 year in each group, time to employment, earnings, community participation, and other aspects of well-being. Findings from this study will be used to determine which ways of delivering services are most effective in enabling employment by 1 year after injury, and to provide information to help other rehabilitation centers adopt effective programs.
Study design
- Primary purpose
- Treatment
- 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 age 18 to 62
- a neurological impairment secondary to an SCI that occurred less than 12 months prior to enrollment
- receiving inpatient rehabilitation at Kessler Institute for Rehabilitation (KIR)
- community living in the state of NJ after discharge from KIR
- have a goal to pursue competitive integrated employment or education/retraining leading to competitive integrated employment
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 participants 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 participants 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 (Percent Employed)
Time frame: 12-months post-enrollment
Proportion of participants in each group in competitive employment.
10 secondary outcomes
Employment Efficiency (Median Time to Employment)
Time frame: 12-months post-enrollment
Income
Time frame: 12-months post-enrollment
Satisfaction with Life Scale (SWLS)
Time frame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
International SCI Quality of Life Basic Data Set
Time frame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Craig Handicap Assessment and Reporting Technique (CHART)
Time frame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Spinal Cord Injury Quality of Life: Satisfaction with Social Roles and Activities (SCI-QoL)
Time frame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Patient Health Questionnaire (PHQ-9)
Time frame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Spinal Cord Injury Quality of Life: Self-Esteem
Time frame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Spinal Cord Injury Quality of Life: Independence
Time frame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Exit Survey
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 18 Aug 2022.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD), except if/when limited by data use agreements established with the New Jersey Department of Labor, will be shared via the Interuniversity Consortium for Political and Social Research (ICPSR), the preferred data repository for the National Institute on Disability, Independent Living, and Rehabilitation Research. Data shared via ICPSR will include data from measures collected at baseline and follow-ups for purposes of sample characterization and/or outcomes assessment. All data will be de-identified and labeled with subject identification numbers established for the study rather than names or initials.
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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.
Trevor Dyson-Hudson, M.D. principal investigator
Kessler Foundation
John O'Neill, Ph.D. principal investigator
Kessler Foundation
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 Spinal Cord Diseases, 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 18 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 Trevor Dyson-Hudson, M.D. (973-324-3576, tdysonhudson@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Employment Status (Percent Employed) (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 18 Aug 2022.