Validation of the French Adaptation of the MSWDQ-23 Questionnaire
WORKSEP
Validation Study of the French Adaptation of the MSWDQ-23 Questionnaire, a Tool Assessing the Work Difficulties of Patients With Multiple Sclerosis.
1 other identifier
observational
206
1 country
16
Brief Summary
MS is an autoimmune disease of the central nervous system that affects more than 120,000 people in France. The average age of onset of the disease is between 25 and 35 years. Given the wide range of ages of the patients, from 4 to 80 years, the ethical and socio-economic stakes are high in order to maintain their autonomy, sociability, family and intimate life, and their employment in the best possible conditions and for as long as possible. However, to date, there are no evaluation tools in French that allow us to understand the difficulties at work of MS patients. The Multiple Sclerosis Work Difficulties Questionnaire (MSWDQ-23) was developed specifically for MS patients and validated in English \[1\]. There is a short version of this questionnaire that facilitates its use in clinical practice \[2\]. It has been translated and validated in Spanish through a multicenter study, and is currently being validated in German, but does not currently exist in French \[3\]. The main objective of the WORKSEP project is to validate the French version of this questionnaire through a multicenter population-based cohort within the framework of the French-speaking Multiple Sclerosis Society (SFSEP). This validation study will involve the inclusion of 206 French-speaking MS patients, regardless of their professional status, all forms of MS combined, from the early stage (Clinically Isolated Syndrome) to the more advanced stages (primary and secondary progressive forms).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2021
CompletedFirst Posted
Study publicly available on registry
April 27, 2021
CompletedStudy Start
First participant enrolled
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedFebruary 5, 2024
February 1, 2024
2.1 years
April 23, 2021
February 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
MSWDQ-23 score
total score out of 100
1 day
Study Arms (1)
Multiple Sclerosis patients
Interventions
Patients will complete the MSWDQ-23 in French, as well as the DEX, questionnaire for the evaluation of executive dysfunction in daily life, to evaluate their cognitive complaints and the SF36 questionnaire to evaluate their quality of life
Eligibility Criteria
French-speaking MS patients with or without cognitive complaints and regardless of their occupational status will be prospectively recruited at their scheduled disease follow-up consultation
You may qualify if:
- Age between 18 and 65 years old.
- Native French speaker.
- A diagnosis of Clinically Isolated Syndrome or MS defined according to the 2017 McDonald criteria.
- Be affiliated with the social security system.
- Agree to participate in the study.
You may not qualify if:
- Opposition to the use of the data
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Besancon University Hospital
Besançon, 25030, France
Bordeaux university hospital
Bordeaux, 33404, France
Caen university hospital
Caen, 14033, France
Clermont Ferrand university hospital
Clermont-Ferrand, 63003, France
Gonesse hospital
Gonesse, 95503, France
Libourne hospital
Libourne, 33505, France
Lille University Hospital
Lille, 59000, France
Groupement des Hôpitaux de l'Institut Catholique de Lille
Lomme, 59462, France
Lyon University Hospital
Lyon, 69229, France
Marseille University Hospital
Marseille, 13000, France
Nancy Hospital
Nancy, 54000, France
Nimes university hospital
Nîmes, 30029, France
APHP
Paris, 75651, France
Rouen univestity hospital
Rouen, 76000, France
Saint Etienne University Hospital
Saint-Etienne, 42055, France
Strasnourg university hospital
Strasbourg, 67000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2021
First Posted
April 27, 2021
Study Start
May 10, 2021
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
February 5, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share