Mental Health Consequences of COVID19 Infection in the French RMD Cohort (MentCovid19RMD)

January 11, 2023 updated by: University Hospital, Lille

Mental Health Consequences of COVID19 Infection in the French Rheumatic Musculoskeletal Diseases (RMD) Cohort

this observational, cross-sectional, national, comparative study, including RMD patients followed in hospital centres of the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners caring for patients suffering from inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases. The objective of the study is to compare RMD patients with COVID 19 infection (cases) to RMD patients who have not had COVID 19 infection (controls) on their mental health.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

296

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Lille, France, 59037
        • Hop Claude Huriez Chu Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be recruited from the French RMD covid19 cohort (ClinicalTrials.gov Identifier: NCT04353609) including patients from hospitals in the FAI²R Rare Diseases Healthcare Pathway network and specialist private practitioners (rheumatologists, internists with mixed hospital and private practice activities) caring for patients with inflammatory rheumatism, systemic autoimmune diseases and auto-inflammatory diseases.

Description

Inclusion Criteria:

Patient case:

  • Patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease
  • With confirmed COVID-19 infection (at least one month prior to study inclusion)
  • Study information given to the patient
  • Patient affiliated to social security

Patient control:

  • Patient with inflammatory rheumatism, systemic autoimmune disease or autoimmune disease.
  • Not having had a confirmed COVID-19 infection
  • Study information given to the patient
  • Patient affiliated to social security

Exclusion Criteria:

  • Opposition to participation in the study by the patient and/or his legal representative
  • Adult patient not able to understand the implications and rules of the study
  • Protected adults under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
case group
RMD patients with COVID 19 infection
control group
RMD patients without COVID 19 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID
Time Frame: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection
at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection

Secondary Outcome Measures

Outcome Measure
Time Frame
Severity of PTSD depending on whether or not autoimmune patients have experienced COVID
Time Frame: at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection
at one month following exposure to the traumatic factor (i.e. one month from COVID-19 infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

FAI²R (Auto-immune and auto-inflammatory rare diseases French network)

Investigators

  • Principal Investigator: Eric Hachulla, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2021

Primary Completion (Actual)

May 19, 2022

Study Completion (Actual)

May 19, 2022

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Estimate)

January 13, 2023

Last Update Submitted That Met QC Criteria

January 11, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_75
  • 2020-A02058-31 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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