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NCT04100525 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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