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.

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: questionnaires

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • Besançon University Hospital
  • Bordeaux, France, 33404
    • Bordeaux University Hospital
  • Caen, France, 14033
    • Caen University Hospital
  • Clermont-Ferrand, France, 63003
    • Clermont Ferrand University Hospital
  • Gonesse, France, 95503
    • Gonesse hospital
  • Libourne, France, 33505
    • Libourne Hospital
  • Lille, France, 59000
    • Lille University Hospital
  • Lomme, France, 59462
    • Groupement des Hôpitaux de l'Institut Catholique de Lille
  • Lyon, France, 69229
    • Lyon University Hospital
  • Marseille, France, 13000
    • Marseille University hospital
  • Nancy, France, 54000
    • Nancy Hospital
  • Nîmes, France, 30029
    • Nimes University Hospital
  • Paris, France, 75651
    • APHP
  • Rouen, France, 76000
    • Rouen univestity hospital
  • Saint-Étienne, France, 42055
    • Saint Etienne University Hospital
  • Strasbourg, France, 67000
    • Strasnourg university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Multiple Sclerosis patients	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MSWDQ-23 score	total score out of 100	1 day

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 23, 2021
• First Submitted That Met QC Criteria: April 23, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 20-PP-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No