NCT04860791

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

February 5, 2024

Status Verified

February 1, 2024

Enrollment Period

2.1 years

First QC Date

April 23, 2021

Last Update Submit

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

Other: questionnaires

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

Multiple Sclerosis patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

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

Location

Bordeaux university hospital

Bordeaux, 33404, France

Location

Caen university hospital

Caen, 14033, France

Location

Clermont Ferrand university hospital

Clermont-Ferrand, 63003, France

Location

Gonesse hospital

Gonesse, 95503, France

Location

Libourne hospital

Libourne, 33505, France

Location

Lille University Hospital

Lille, 59000, France

Location

Groupement des Hôpitaux de l'Institut Catholique de Lille

Lomme, 59462, France

Location

Lyon University Hospital

Lyon, 69229, France

Location

Marseille University Hospital

Marseille, 13000, France

Location

Nancy Hospital

Nancy, 54000, France

Location

Nimes university hospital

Nîmes, 30029, France

Location

APHP

Paris, 75651, France

Location

Rouen univestity hospital

Rouen, 76000, France

Location

Saint Etienne University Hospital

Saint-Etienne, 42055, France

Location

Strasnourg university hospital

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

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

Locations