Back to resultsIntervention for Employed Women With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neuropsychological testing intervention plus follow up
Sponsored by
About this trial
This is an interventional prevention trial for Multiple Sclerosis focused on measuring Employment, Vocational Rehabilitation
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Care
Experimental Treatment
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Employment
Has there been a decrease in employment status (Yes/No)
Secondary Outcome Measures
Adherence to Recommendations
Percentage of recommendations completed at one year
Full Information
NCT ID
NCT04100525
First Posted
September 20, 2019
Last Updated
February 16, 2021
Sponsor
Holy Name Medical Center, Inc.
Collaborators
Women United in Philanthropy (WUIP)
1. Study Identification
Unique Protocol Identification Number
NCT04100525
Brief Title
Intervention for Employed Women With Multiple Sclerosis
Official Title
Neuropsychological Feedback Style and Case Management to Improve Intervention Outcome for Employed Women With Multiple Sclerosis: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (Actual)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holy Name Medical Center, Inc.
Collaborators
Women United in Philanthropy (WUIP)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Employment, Vocational Rehabilitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants were informed that they would receive feedback but were not told whether it would be in person or by phone until after randomization. Participants were not informed that only one group received case management calls.
Allocation
Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Neuropsychological testing intervention plus follow up
Intervention Description
Neuropsychological testing for women experiencing significant fatigue, mood, or cognitive symptoms. Feedback type and case management services varied depending on randomized group.
Primary Outcome Measure Information:
Title
Employment
Description
Has there been a decrease in employment status (Yes/No)
Time Frame
Approximately 12 months
Secondary Outcome Measure Information:
Title
Adherence to Recommendations
Description
Percentage of recommendations completed at one year
Time Frame
Approximately 12 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study targeted females
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick W Foley, Ph.D.
Organizational Affiliation
Holy Name Medical Center, Ferkauf Graduate School of Psychology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intervention for Employed Women With Multiple Sclerosis
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