NCT05506657

Brief 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. This project will compare two ways of coordinating and delivering services that are designed to help people with spinal cord injury obtain employment.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Sep 2022

Longer than P75 for not_applicable

Status
not yet recruiting

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

Study Progress92%
Sep 2022Aug 2026

First Submitted

Initial submission to the registry

January 19, 2022

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

3.4 years

First QC Date

January 19, 2022

Last Update Submit

August 17, 2022

Conditions

Keywords

employmentvocational rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Employment Status (Percent Employed)

    Proportion of participants in each group in competitive employment.

    12-months post-enrollment

Secondary Outcomes (10)

  • Employment Efficiency (Median Time to Employment)

    12-months post-enrollment

  • Income

    12-months post-enrollment

  • Satisfaction with Life Scale (SWLS)

    Assessed at 1 month (baseline), 6, and 12 months post-enrollment.

  • International SCI Quality of Life Basic Data Set

    Assessed at 1 month (baseline), 6, and 12 months post-enrollment.

  • Craig Handicap Assessment and Reporting Technique (CHART)

    Assessed at 1 month (baseline), 6, and 12 months post-enrollment.

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Other: Center Facilitator-Coordinated Services

Interventions

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.

State Counselor-Coordinated Services

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.

Center Facilitator-Coordinated Services

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord InjuriesSpinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Trevor Dyson-Hudson, M.D.

    Kessler Foundation

    PRINCIPAL INVESTIGATOR
  • John O'Neill, Ph.D.

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Trevor Dyson-Hudson, M.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2022

First Posted

August 18, 2022

Study Start

September 30, 2022

Primary Completion

February 28, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, ICF, ANALYTIC CODE
Time Frame
Data will be made available within 6-12 months of the completion of the study and will remain available indefinitely.
Access Criteria
Requests for data access will be coordinated through the Interuniversity Consortium for Political and Social Research (ICPSR) according to their established procedures.
More information