Mental Health Consequences of COVID19 Infection in the French RMD Cohort

NCT ID: NCT04510467

Last Updated: 2023-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-20

Study Completion Date

2022-05-19

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19 Systemic Autoimmune Disease Inflammatory Rheumatism Auto Inflammatory Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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case group

RMD patients with COVID 19 infection

No interventions assigned to this group

control group

RMD patients without COVID 19 infection

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Hachulla, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2020-A02058-31

Identifier Type: OTHER

Identifier Source: secondary_id

2020_75

Identifier Type: -

Identifier Source: org_study_id

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