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Early Intervention to Promote Return to Work for People With Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries, Spinal Cord Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
State Counselor-Coordinated Services
Center Facilitator-Coordinated Services
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring employment, vocational rehabilitation

Eligibility Criteria

18 Years - 62 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    State Counselor-Coordinated Services

    Center Facilitator-Coordinated Services

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Employment Status (Percent Employed)
    Proportion of participants in each group in competitive employment.

    Secondary Outcome Measures

    Employment Efficiency (Median Time to Employment)
    Median number of months from date of enrollment to date of competitive integrated employment; obtained through self-report.
    Income
    Earnings within the first 12 months post-enrollment as obtained from New Jersey Unemployment Insurance (UI) data.
    Satisfaction with Life Scale (SWLS)
    5 item (2 minute) scale that provides global measure of life satisfaction.
    International SCI Quality of Life Basic Data Set
    3 item (~1 minute) assessment of satisfaction with life as a whole, physical health, psychological health.
    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.
    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.
    Patient Health Questionnaire (PHQ-9)
    Measure of depressive symptomology (9 items; 3 minutes).
    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.
    Spinal Cord Injury Quality of Life: Independence
    8 item (<5 minute) short form.
    Exit Survey
    Includes rating scale and open-ended items pertaining to satisfaction with the program and suggestions for optimization of the programs.

    Full Information

    First Posted
    January 19, 2022
    Last Updated
    August 17, 2022
    Sponsor
    Kessler Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05506657
    Brief Title
    Early Intervention to Promote Return to Work for People With Spinal Cord Injury
    Official Title
    Early Intervention to Promote Return to Work for People With Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2022 (Anticipated)
    Primary Completion Date
    February 28, 2026 (Anticipated)
    Study Completion Date
    August 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kessler Foundation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries, Spinal Cord Diseases
    Keywords
    employment, vocational rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    162 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    State Counselor-Coordinated Services
    Arm Type
    Other
    Arm Description
    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.
    Arm Title
    Center Facilitator-Coordinated Services
    Arm Type
    Other
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    State Counselor-Coordinated Services
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Center Facilitator-Coordinated Services
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Employment Status (Percent Employed)
    Description
    Proportion of participants in each group in competitive employment.
    Time Frame
    12-months post-enrollment
    Secondary Outcome Measure Information:
    Title
    Employment Efficiency (Median Time to Employment)
    Description
    Median number of months from date of enrollment to date of competitive integrated employment; obtained through self-report.
    Time Frame
    12-months post-enrollment
    Title
    Income
    Description
    Earnings within the first 12 months post-enrollment as obtained from New Jersey Unemployment Insurance (UI) data.
    Time Frame
    12-months post-enrollment
    Title
    Satisfaction with Life Scale (SWLS)
    Description
    5 item (2 minute) scale that provides global measure of life satisfaction.
    Time Frame
    Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
    Title
    International SCI Quality of Life Basic Data Set
    Description
    3 item (~1 minute) assessment of satisfaction with life as a whole, physical health, psychological health.
    Time Frame
    Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
    Title
    Craig Handicap Assessment and Reporting Technique (CHART)
    Description
    Subscales examine several objective physical independence, cognitive independence, mobility, occupation, social integration, and economic self-sufficiency; includes personal care assistance use.
    Time Frame
    Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
    Title
    Spinal Cord Injury Quality of Life: Satisfaction with Social Roles and Activities (SCI-QoL)
    Description
    10 item short form (<5 minutes) examining extent of satisfaction or disappointment with social roles and activities; complements CHART.
    Time Frame
    Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
    Title
    Patient Health Questionnaire (PHQ-9)
    Description
    Measure of depressive symptomology (9 items; 3 minutes).
    Time Frame
    Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
    Title
    Spinal Cord Injury Quality of Life: Self-Esteem
    Description
    8 item (<5 minute) short form; assesses emotional, evaluative, and cognitive perceptions of personal competence and worth.
    Time Frame
    Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
    Title
    Spinal Cord Injury Quality of Life: Independence
    Description
    8 item (<5 minute) short form.
    Time Frame
    Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
    Title
    Exit Survey
    Description
    Includes rating scale and open-ended items pertaining to satisfaction with the program and suggestions for optimization of the programs.
    Time Frame
    12-months post-enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    62 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Trevor Dyson-Hudson, M.D.
    Phone
    973-324-3576
    Email
    tdysonhudson@kesslerfoundation.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    John O'Neill, Ph.D.
    Phone
    973-324-8387
    Email
    Joneill@kesslerfoundation.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Trevor Dyson-Hudson, M.D.
    Organizational Affiliation
    Kessler Foundation
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    John O'Neill, Ph.D.
    Organizational Affiliation
    Kessler Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    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.
    IPD Sharing Time Frame
    Data will be made available within 6-12 months of the completion of the study and will remain available indefinitely.
    IPD Sharing Access Criteria
    Requests for data access will be coordinated through the Interuniversity Consortium for Political and Social Research (ICPSR) according to their established procedures.
    IPD Sharing URL
    https://www.icpsr.umich.edu/web/pages/

    Learn more about this trial

    Early Intervention to Promote Return to Work for People With Spinal Cord Injury

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