Validation of the French Adaptation of the MSWDQ-23 Questionnaire

Multiple Sclerosis Clinical Trial

— WORKSEP  

Official title:

Validation Study of the French Adaptation of the MSWDQ-23 Questionnaire, a Tool Assessing the Work Difficulties of Patients With Multiple Sclerosis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04860791
• Other study ID #: 20-PP-03
• Status: Completed
• Start date: May 10, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

Opposition to the use of the data

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• questionnaires
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

Locations

Country	Name	City	State
France	Besancon University Hospital	Besançon
France	Bordeaux university hospital	Bordeaux
France	Caen university hospital	Caen
France	Clermont Ferrand university hospital	Clermont-Ferrand
France	Gonesse hospital	Gonesse
France	Libourne hospital	Libourne
France	Lille University Hospital	Lille
France	Groupement des Hôpitaux de l'Institut Catholique de Lille	Lomme
France	Lyon University Hospital	Lyon
France	Marseille University Hospital	Marseille
France	Nancy Hospital	Nancy
France	Nimes university hospital	Nîmes
France	APHP	Paris
France	Rouen univestity hospital	Rouen
France	Saint Etienne University Hospital	Saint-Étienne
France	Strasnourg university hospital	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MSWDQ-23 score	total score out of 100	1 day