Clinical trial NCT05506657: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Keywords: employment
vocational rehabilitation
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Employment Status (Percent Employed)
timeFrame: 12-months post-enrollment
Secondary outcomes:
measure: Employment Efficiency (Median Time to Employment)
timeFrame: 12-months post-enrollment
measure: Income
timeFrame: 12-months post-enrollment
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
measure: International SCI Quality of Life Basic Data Set
timeFrame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
measure: Craig Handicap Assessment and Reporting Technique (CHART)
timeFrame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
measure: Spinal Cord Injury Quality of Life: Satisfaction with Social Roles and Activities (SCI-QoL)
timeFrame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
measure: Spinal Cord Injury Quality of Life: Self-Esteem
timeFrame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
measure: Spinal Cord Injury Quality of Life: Independence
timeFrame: Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
measure: Exit Survey
timeFrame: 12-months post-enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Kessler Foundation
name: Trevor Dyson-Hudson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kessler Foundation
name: John O'Neill, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: