ClinicalTrials.gg
Status unknownNCT04100525Updated Feb 18, 2021

Intervention for Employed Women With Multiple Sclerosis

An interventional study of Neuropsychological testing intervention plus follow up in Multiple Sclerosis, sponsored by Holy Name Medical Center, Inc.. Status unknown. Open to female participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-18.

Sponsored by Holy Name Medical Center, Inc. · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Apr 2016, registered Sep 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
89
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Female
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Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Employment
  • Vocational Rehabilitation
03

In context

Multiple Sclerosis

3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.

This study's enrollment of 89 is above the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Holy Name Medical Center, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female sex
  • Age between 18 and 64
  • Employed at least 20 hours per week
  • Confirmed diagnosis of MS

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
89 participants (actual)

Study arms

  • Active comparator
    Standard Care

    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.

    Behavioral: Neuropsychological testing intervention plus follow up

  • Experimental
    Experimental Treatment

    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).

    Behavioral: Neuropsychological testing intervention plus follow up

Interventions

  • BehavioralNeuropsychological 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.

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What researchers measure

Primary outcomes

  1. Employment

    Has there been a decrease in employment status (Yes/No)

    Time frame: Approximately 12 months

Secondary outcomes

  1. Adherence to Recommendations

    Percentage of recommendations completed at one year

    Time frame: Approximately 12 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04100525
Lead sponsor
Holy Name Medical Center, Inc.
Collaborators
Women United in Philanthropy (WUIP)
Responsible party
Sponsor
First posted
Sep 24, 2019
Start date
Apr 2016
Primary completion
Feb 2020
Completion
Jan 2022 (estimated)
Last update
Feb 18, 2021

Study contacts

Frederick W Foley, Ph.D.
principal investigator · Holy Name Medical Center, Ferkauf Graduate School of Psychology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.

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