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NCT Number: NCT05506657

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–62 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

State Counselor-Coordinated Services

Other

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 Services

Other

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 outcomes

  1. Employment Status (Percent Employed)

    Time frame: 12-months post-enrollment

    Proportion of participants in each group in competitive employment.

Secondary outcomes

  1. Employment Efficiency (Median Time to Employment)

    Time frame: 12-months post-enrollment

    Median number of months from date of enrollment to date of competitive integrated employment; obtained through self-report.

  2. Income

    Time frame: 12-months post-enrollment

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

  3. Satisfaction with Life Scale (SWLS)

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

    5 item (2 minute) scale that provides global measure of life satisfaction.

  4. International SCI Quality of Life Basic Data Set

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

    3 item (~1 minute) assessment of satisfaction with life as a whole, physical health, psychological health.

  5. Craig Handicap Assessment and Reporting Technique (CHART)

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

    Subscales examine several objective physical independence, cognitive independence, mobility, occupation, social integration, and economic self-sufficiency; includes personal care assistance use.

  6. 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.

    10 item short form (<5 minutes) examining extent of satisfaction or disappointment with social roles and activities; complements CHART.

  7. Patient Health Questionnaire (PHQ-9)

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

    Measure of depressive symptomology (9 items; 3 minutes).

  8. Spinal Cord Injury Quality of Life: Self-Esteem

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

    8 item (<5 minute) short form; assesses emotional, evaluative, and cognitive perceptions of personal competence and worth.

  9. Spinal Cord Injury Quality of Life: Independence

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

    8 item (<5 minute) short form.

  10. Exit Survey

    Time frame: 12-months post-enrollment

    Includes rating scale and open-ended items pertaining to satisfaction with the program and suggestions for optimization of the programs.

Study contacts

Contact information is provided by the study sponsor or research team.

John O'Neill, Ph.D.

CONTACT

[email protected]

973-324-8387

Trevor Dyson-Hudson, M.D.

CONTACT

[email protected]

973-324-3576

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Aug 18, 2022
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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