Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04510467
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : November 17, 2020
Sponsor:
Collaborator:
FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease
Covid19 Systemic Autoimmune Disease Inflammatory Rheumatism Auto Inflammatory Diseases

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1313 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Mental Health Consequences of COVID19 Infection in the French Rheumatic Musculoskeletal Diseases (RMD) Cohort
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510467


Contacts
Layout table for location contacts
Contact: Eric Hachulla, MD,PhD 0320445962 ext +33 eric.hachulla@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
FAI²R (Auto-immune and auto-inflammatory rare diseases French network)
Investigators
Layout table for investigator information
Principal Investigator: Eric Hachulla, MD,PhD University Hospital, Lille
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04510467    
Other Study ID Numbers: 2020_75
2020-A02058-31 ( Other Identifier: ID-RCB number,ANSM )
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: November 17, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rheumatic Fever
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Arthritis
Joint Diseases