Impact of the Modifications of Environmental Exposures and Health Care Access During COVID-19 Lockdown on Multiple Sclerosis

NCT05033782 | Completed

• 1 other identifier: APHP210935
• Study Type: observational
• Target: 1,209
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis (MS) is a demyelinating auto immune disease of the central nervous system, affecting 2500000 people worldwide. Risk factors for MS severity are not yet well-known , but previous studies highlighted that relapse rate increased during influenzae epidemics, and air pollution could be a risk factor for MS relapses. MS is a neurological chronic disease that requires constant medical treatment and regular rehabilitation care. COVID-19 pandemic and restrictive measures taken to limit contaminations have drastically decreased air pollution and seasonal viral infections exposure, but sanitary crisis also limited care access for MS patients (medical treatment, rehabilitation). Therefore, this particular period offers a unique opportunity to evaluate the impact of air pollution, viral infections, and health care access on the severity of MS. The main objective is to evaluate the impact of air pollution and seasonal viral infections on the risk of MS relapse, using the year 2020 as a quasi-experimental model. The secondary objective will be to evaluate the impact of health care access limitations on the risk of neurological disability accumulation. This study will include 1500 MS patients, living in Ile de France, followed in the neurological department of "Pitié-Salpêtrière" Hospital. This is a retrospective observational study nested in OFSEP registry (French Multiple Sclerosis Observatory), which is a prospective cohort of MS patients in France. Air pollution data will come from AIRPARIF, and viral infections data will come from "Santé Publique France". A better knowledge of the impact of air pollution, viral infections, and health care access on the course of MS will enable to better guide information to patients and public health care decisions.

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis; Lockdown; COVID-19; Air pollution; Influenza, Human; Gastroenteritis; Health Services Accessibility

Outcome Measures

Primary Outcomes (1)

• Multiple Sclerosis Relapse

  a neurologic deficit associated with an acute inflammatory demyelinating event that lasts at least 24 hours in the absence of fever and infection

  01/01/2018 - 01/01/2022

Secondary Outcomes (1)

• Neurological disability accumulation

  01/01/2018 - 01/01/2022

Study Arms (1)

MS patients

This group includes patients living in Ile de France, followed in the neurology department of the Pitié Salpêtrière Hospital in Paris for relapsing-remitting MS. Clinical examination will be performed to evaluate the disability (EDSS scale), as part of the care (systematic for all MS consultations) \- A paper questionnaire is given to the patient during the consultation. The patient will be contacted by telephone within 15 days after the consultation by a health care staff to collect the answers to the questionnaire.

Other: questionnaire

Interventions

questionnaire OTHER

Each included patient will be given a paper questionnaire, with the following questions: * Zip code of patient's iterative residences since 2018, as well as the zip code of residence at the time of the 2 confinements * Occupational status * Occurrence of COVID infection/date needed for hospitalization * During the COVID-19 outbreak, did the patient: avoid seeing a doctor, avoid going to health care facilities, stop background treatment for MS. If yes to any of the questions, the reason, date and duration of the cessation will be asked. Other sources of data will be used together: Clinical data from the OFSEP registry Pollution data from approved air quality monitoring associations Data on the circulation of influenza and gastroenteritis, produced by Santé Publique France

MS patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients living in Ile de France and followed in the neurology department of the Pitié Salpêtrière Hospital in Paris for relapsing-remitting MS.

You may qualify if:

• MS defined by the Mac-Donald 2017 criteria
• Age greater than or equal to 18 years
• Relapsing-remitting form
• Patient residing in Ile de France
• Patient included in the OFSEP registry (French Multiple Sclerosis Observatory) with at least one visit before 2020 and at least one after January 2021

You may not qualify if:

• Secondary progressive or primary progressive MS

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Neurology Department, Hopital de la Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Multiple Sclerosis; COVID-19; Influenza, Human; Gastroenteritis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Edouard Januel, MD

  Assistance Publique Hopitaux Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 5, 2021
• Study Start: February 8, 2022
• Primary Completion: February 8, 2025
• Study Completion: February 8, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)