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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05506657
• Other study ID #: L-1171-21A
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: August 2022
• Source: Kessler Foundation
• Contact: Trevor Dyson-Hudson, M.D.
• Phone: 973-324-3576
• Email: tdysonhudson[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: August 31, 2026
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 62 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Diseases
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• State Counselor-Coordinated Services
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Employment Status (Percent Employed)	Proportion of participants in each group in competitive employment.	12-months post-enrollment
Secondary	Employment Efficiency (Median Time to Employment)	Median number of months from date of enrollment to date of competitive integrated employment; obtained through self-report.	12-months post-enrollment
Secondary	Income	Earnings within the first 12 months post-enrollment as obtained from New Jersey Unemployment Insurance (UI) data.	12-months post-enrollment
Secondary	Satisfaction with Life Scale (SWLS)	5 item (2 minute) scale that provides global measure of life satisfaction.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Secondary	International SCI Quality of Life Basic Data Set	3 item (~1 minute) assessment of satisfaction with life as a whole, physical health, psychological health.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Secondary	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.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Secondary	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.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Secondary	Patient Health Questionnaire (PHQ-9)	Measure of depressive symptomology (9 items; 3 minutes).	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Secondary	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.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Secondary	Spinal Cord Injury Quality of Life: Independence	8 item (<5 minute) short form.	Assessed at 1 month (baseline), 6, and 12 months post-enrollment.
Secondary	Exit Survey	Includes rating scale and open-ended items pertaining to satisfaction with the program and suggestions for optimization of the programs.	12-months post-enrollment