Intervention for Employed Women With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Neuropsychological Feedback Style and Case Management to Improve Intervention Outcome for Employed Women With Multiple Sclerosis: a Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04100525
• Other study ID #: Employment Study
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2016
• Est. completion date: January 2022

Study information

• Verified date: February 2021
• Source: Holy Name Medical Center, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Unemployment is particularly common among women with multiple sclerosis (MS). This study uses a vocational rehabilitation program involving neuropsychological testing as an intervention. The use of in-person feedback and case management following neuropsychological testing is compared to phone feedback only. Adherence to treatment and employment outcomes will be evaluated over three years.

Description:

Employed women at a tertiary-care MS center were screened for common issues impacting work productivity (fatigue, cognitive dysfunction, and depression). Women who met screening criteria were randomized to one of two treatment groups: either neuropsychological testing and phone feedback to review findings and tailored recommendations (standard-care treatment); or neuropsychological testing, in-person feedback, and two calls from a care-coordinator (experimental treatment). Adherence to recommendations and employment status at one year are evaluated. Follow-up periods also occur at year two and year three.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 89
• Est. completion date: January 2022
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Female sex

• Age between 18 and 64

• Employed at least 20 hours per week

• Confirmed diagnosis of MS

Exclusion Criteria:

• Experiencing an MS exacerbation

• Endorsing suicidal ideation or intent

• Pregnant

• Severe psychiatric disorder

• History of traumatic brain injury

• Dementia

• Major neurological illness other than MS

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Neuropsychological testing intervention plus follow up
Neuropsychological testing for women experiencing significant fatigue, mood, or cognitive symptoms. Feedback type and case management services varied depending on randomized group.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Holy Name Medical Center, Inc.	Women United in Philanthropy (WUIP)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Employment	Has there been a decrease in employment status (Yes/No)	Approximately 12 months
Secondary	Adherence to Recommendations	Percentage of recommendations completed at one year	Approximately 12 months