Intervention for Employed Women With Multiple Sclerosis

February 16, 2021 updated by: Holy Name Medical Center, Inc.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Neuropsychological testing for women experiencing significant fatigue, mood, or cognitive symptoms. Feedback type and case management services varied depending on randomized group.
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
Neuropsychological testing for women experiencing significant fatigue, mood, or cognitive symptoms. Feedback type and case management services varied depending on randomized group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Employment
Time Frame: Approximately 12 months
Has there been a decrease in employment status (Yes/No)
Approximately 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to Recommendations
Time Frame: Approximately 12 months
Percentage of recommendations completed at one year
Approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holy Name Medical Center, Inc.

Collaborators

Women United in Philanthropy (WUIP)

Investigators

  • Principal Investigator: Frederick W Foley, Ph.D., Holy Name Medical Center, Ferkauf Graduate School of Psychology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (ACTUAL)

September 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Employment Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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