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Clinical Trials/NCT05506657
NCT05506657
Not yet recruiting
Not Applicable

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

Kessler Foundation0 sites162 target enrollmentSeptember 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injuries
Sponsor
Kessler Foundation
Enrollment
162
Primary Endpoint
Employment Status (Percent Employed)
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 30, 2022
End Date
August 31, 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Employment Status (Percent Employed)

Time Frame: 12-months post-enrollment

Proportion of participants in each group in competitive employment.

Secondary Outcomes

  • Income(12-months post-enrollment)
  • International SCI Quality of Life Basic Data Set(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)(Assessed at 1 month (baseline), 6, and 12 months post-enrollment.)
  • Patient Health Questionnaire (PHQ-9)(Assessed at 1 month (baseline), 6, and 12 months post-enrollment.)
  • Employment Efficiency (Median Time to Employment)(12-months post-enrollment)
  • Craig Handicap Assessment and Reporting Technique (CHART)(Assessed at 1 month (baseline), 6, and 12 months post-enrollment.)
  • Spinal Cord Injury Quality of Life: Self-Esteem(Assessed at 1 month (baseline), 6, and 12 months post-enrollment.)
  • Satisfaction with Life Scale (SWLS)(Assessed at 1 month (baseline), 6, and 12 months post-enrollment.)
  • Spinal Cord Injury Quality of Life: Independence(Assessed at 1 month (baseline), 6, and 12 months post-enrollment.)
  • Exit Survey(12-months post-enrollment)

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