Intervention for Employed Women With Multiple Sclerosis

NCT04100525 | Unknown

• 1 other identifier: Employment Study
• Study Type: interventional
• Target: 89
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Multiple Sclerosis

Keywords

Employment; Vocational Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Employment

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

  Approximately 12 months

Secondary Outcomes (1)

• Adherence to Recommendations

  Approximately 12 months

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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 Treatment

EXPERIMENTAL

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

Neuropsychological testing intervention plus follow up BEHAVIORAL

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

Experimental Treatment; Standard Care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: Study targeted females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Holy Name Medical Center, Inc.: lead
• Women United in Philanthropy (WUIP): collaborator

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Frederick W Foley, Ph.D.

  Holy Name Medical Center, Ferkauf Graduate School of Psychology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 24, 2019
• Study Start: April 1, 2016
• Primary Completion: February 1, 2020
• Study Completion: January 1, 2022
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share