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

University Hospital, Lille1 site in 1 country296 target enrollmentJanuary 20, 2021

ConditionsCovid19 Systemic Autoimmune Disease Inflammatory Rheumatism Auto Inflammatory Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Covid19
Sponsor: University Hospital, Lille
Enrollment: 296
Locations: 1
Primary Endpoint: Frequency of PTSD depending on whether or not autoimmune patients have experienced COVID
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 20, 2021

End Date

May 19, 2022

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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