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NCT04510467 Clinical Trial

Mental Health Consequences of COVID19 Infection in the French RMD Cohort

Covid19 Clinical Trial

— MentCovid19RMD  

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04510467
Other study ID # 2020_75
Secondary ID 2020-A02058-31
Status Terminated
Phase
First received
Last updated
Start date January 20, 2021
Est. completion date May 19, 2022

Study information
Verified date January 2023
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 296
Est. completion date May 19, 2022
Est. primary completion date May 19, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Hop Claude Huriez Chu Lille Lille

Sponsors (2)
Lead Sponsor Collaborator
University Hospital, Lille FAI²R (Auto-immune and auto-inflammatory rare diseases French network)

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency 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
Secondary 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
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