Mental Health Consequences of COVID19 Infection in the French RMD Cohort

NCT04510467 | Terminated

• 2 other identifiers: 2020_752020-A02058-31
• Study Type: observational
• Target: 296
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Systemic Autoimmune Disease; Inflammatory Rheumatism; Auto Inflammatory Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

case group

RMD patients with COVID 19 infection

control group

RMD patients without COVID 19 infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patient case:
• Patient with inflammatory rheumatism, systemic autoimmune or autoimmune disease
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• FAI²R (Auto-immune and auto-inflammatory rare diseases French network): collaborator

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

COVID-19; Rheumatic Fever

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eric Hachulla, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 12, 2020
• Study Start: January 20, 2021
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

FR (1)