Validation of the French Adaptation of the MSWDQ-23 Questionnaire

NCT ID: NCT04860791

Last Updated: 2024-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

206 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-10

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multiple Sclerosis patients

questionnaires

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Besancon University Hospital

Besançon, , France

Site Status

Bordeaux university hospital

Bordeaux, , France

Site Status

Caen university hospital

Caen, , France

Site Status

Clermont Ferrand university hospital

Clermont-Ferrand, , France

Site Status

Gonesse hospital

Gonesse, , France

Site Status

Libourne hospital

Libourne, , France

Site Status

Lille University Hospital

Lille, , France

Site Status

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, , France

Site Status

Lyon University Hospital

Lyon, , France

Site Status

Marseille University Hospital

Marseille, , France

Site Status

Nancy Hospital

Nancy, , France

Site Status

Nimes university hospital

Nîmes, , France

Site Status

APHP

Paris, , France

Site Status

Rouen univestity hospital

Rouen, , France

Site Status

Saint Etienne University Hospital

Saint-Etienne, , France

Site Status

Strasnourg university hospital

Strasbourg, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20-PP-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Emotions in Multiple Sclerosis
NCT04804787 COMPLETED NA