Intervention for Employed Women With Multiple Sclerosis

Not Applicable

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Neuropsychological testing intervention plus follow up

• Registration Number: NCT04100525
• Lead Sponsor: Holy Name Medical Center, Inc.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Primary Completion: 2020-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Neuropsychological testing intervention plus follow up	Participant received neuropsychological testing, report detailing cognitive strengths and weaknesses, tailored recommendations to address areas of weakness (including psychological and/or physical symptoms impacting work productivity). Participant received a copy of this report in the mail and a call from the psychologist to go over test findings and recommendations.
Experimental Treatment	Neuropsychological testing intervention plus follow up	Participant received neuropsychological testing, report detailing cognitive strengths and weaknesses, tailored recommendations to address areas of weakness (including psychological and/or physical symptoms impacting work productivity). Participant then receives in-person feedback (and a copy of the report at this visit) and two calls from a care-coordinator research nurse at approximately 1 and 6 months post feedback, who asks participant whether they completed recommendations and assist participant in completing recommendations where possible (i.e., help find a provider, explanation of importance of completing recommendations, etc).

Primary Outcome Measures

Name	Time	Method
Employment	Approximately 12 months	Has there been a decrease in employment status (Yes/No)

Secondary Outcome Measures

Name	Time	Method
Adherence to Recommendations	Approximately 12 months	Percentage of recommendations completed at one year