- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07380295
Improving Workforce Participation and Well-Being in Individuals With Multiple Sclerosis - A Feasability Study
Improving Workforce Participation and Well-Being in Individuals With Multiple Sclerosis- A Feasability Study
Multiple sclerosis (MS) is a chronic neurodegenerative disease and a leading cause of reduced workforce participation due to neurological illness in Western countries. Over the past 30 years, new treatments have reduced symptom burden, allowing patients to stay in the workforce longer. However, fatigue and cognitive impairments remain major barriers to work capacity. This project aims to preliminary examine the impact of cognitive function on work ability, and assess the role of neuropsychologists in multidisciplinary rehabilitation teams. It consists of a feasibility study evaluating the integration of neuropsychological interventions into teambased work-oriented rehabilitation. The specific research questions are:
- How can neuropsychological interventions be integrated into team-based work-oriented rehabilitation?
- How do these interventions relate to work ability and well-being in individuals with MS? The investigators plan to collect data on 20 consecutively patients with MS before, 6 months after and 2 years after a neuropsychological testing and intervention. The patients are being followed on measures related to well-being and work ability. Data from the neuropsychological assessment, other rehabilitation interventions as well as data related to treatment and progress of MS are also collected.
Our findings aim to enhance work-oriented rehabilitation and provide a deeper understanding of how to support individuals with MS in maintaining employment and overall well-being
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Natascha Ekdahl
- Phone Number: +4626278023
- Email: natascha.ekdahl@regiongavleborg.se
Study Locations
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Gävle, Sweden
- Recruiting
- Gävle Hospital
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Contact:
- Natascha Ekdahl
- Phone Number: +4626278023
- Email: natascha.ekdahl@regiongavleborg.se
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Multiple sclerosis Age between 18-65 Refered to neuropsychological assessment at the Neurology departement at Gävle Hospital -
Exclusion Criteria:
Other diagnosis hindering work participation more than MS
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Patients with multiple scleroris of working age
Patients with MS and of working age (18-65) referred to neuropsychological evaluation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Work participation
Time Frame: From baseline to 2-year follow-up
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Percentage of full-time work.
100 % full-time work and 0% is not working at all.
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From baseline to 2-year follow-up
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Hospital anxiety and depression scale
Time Frame: From baseline to 2-year follow-up
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Self-assessment of anxiety and depression.
Consists of two scales measuring the probability of having anxiety and depression respectively.
Min score 0, max 21 for each scale.
Higher scores indicate higher probability of anxiety/depression.
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From baseline to 2-year follow-up
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WHO-5 Well-Being Index
Time Frame: From baseline to 2-year follow-up
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Overall rating of well-being.
The WHO-5 score range is a raw score of 0-25, which is then multiplied by 4 to get a percentage score of 0-100.
Higher score indicates higher well-being.
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From baseline to 2-year follow-up
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Brief index of job satisfaction
Time Frame: From baseline to 2-year follow-up
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The Brief Index of Affective Job Satisfaction (BIAJS) has a score range of 1 to 5 for each of its four items, based on a 5-point Likert scale where 1 is "strongly disagree" and 5 is "strongly agree".
The total BIAJS score is the sum of these four items, resulting in a possible range from 4 to 20, with higher scores indicating greater affective job satisfaction.
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From baseline to 2-year follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quantative work demands
Time Frame: From baseline to 2-year follow-up
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Questions from the subscale "Quantitative demands" of the Copenhagen Psychosocial Questionnaire (COPSOQ-III) related to the demands of work.
The COPSOQ-III uses Likert-like scales, and its items are coded with values of 0, 25, 50, 75, and 100 to achieve a 0-100 scale.
Higher scores indicate more demands.
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From baseline to 2-year follow-up
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Can-Work-S
Time Frame: From baseline to 2-year follow-up
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Three questions from a questionnaire developed to measure work-life balance after cancer.
Each item ranges from 1 to 5 with higher scores indicating worse work-life balance.
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From baseline to 2-year follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MSCogWork3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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