Clinical trial NCT04860791: Validation of the French Adaptation of the MSWDQ-23 Questionnaire
Official title: Validation Study of the French Adaptation of the MSWDQ-23 Questionnaire, a Tool Assessing the Work Difficulties of Patients With Multiple Sclerosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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).


Eligibility criteria: 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

Primary outcomes:
measure: MSWDQ-23 score
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Besancon University Hospital
city: Bordeaux
country: France
facility: Bordeaux university hospital
city: Caen
country: France
facility: Caen university hospital
city: Clermont-Ferrand
country: France
facility: Clermont Ferrand university hospital
city: Gonesse
country: France
facility: Gonesse hospital
city: Libourne
country: France
facility: Libourne hospital
city: Lille
country: France
facility: Lille University Hospital
city: Lomme
country: France
facility: Groupement des Hôpitaux de l'Institut Catholique de Lille
city: Lyon
country: France
facility: Lyon University Hospital
city: Marseille
country: France
facility: Marseille University Hospital
city: Nancy
country: France
facility: Nancy Hospital
city: Nîmes
country: France
facility: Nimes university hospital
city: Paris
country: France
facility: APHP
city: Rouen
country: France
facility: Rouen univestity hospital
city: Saint-Étienne
country: France
facility: Saint Etienne University Hospital
city: Strasbourg
country: France
facility: Strasnourg university hospital
Study officials:
References: