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Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak (PRPsyCOVID)

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ClinicalTrials.gov Identifier: NCT04351399
Recruitment Status : Completed
First Posted : April 17, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief Summary:

Clinical data about psychological impact of quarantine are well studied in transient event or more prolonged situation like jail incarceration.

In recent metaanalysis, psychological impact of quarantine was well documented in a specific population during first SARS epidemy. Even after the end of quarantine several patients were still with symptom of avoiding mainly agoraphobia, frequent hand washing and a carefull return to normal life COVID-19 infection is already associated with psychological symptom like anxiety, depression, sleep disorders and symptoms of acute stress However psychological impact of quarantine is on none in chronic painful inflammatory rheumatism in France. The prevalence of rheumatoid arthritis is 0.5% of the population with frequent comorbidity such as anxiety and depression.

During the quarantine secondary to COVID-19 pandemic it's possible to evaluated the psychological impact of adult RA patients.

The present study is an "emergency" being realize before the end of the quarantine.


Condition or disease Intervention/treatment
Sars-CoV2 Rheumatic Diseases Rheumatoid Arthritis Chronic Pain Other: questionnaire assesment

Study Design
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Study Type : Observational
Actual Enrollment : 318 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak
Actual Study Start Date : April 27, 2020
Actual Primary Completion Date : May 4, 2020
Actual Study Completion Date : May 4, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
patient with chronic painful inflammatory rheumatism Other: questionnaire assesment
The questionnaire will ask questions around their socio-demographic characteristics,quality of life, painful, using analgesic , since they are in quarantine


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of RA patients with emotional impact (feeling of isolation) [ Time Frame: maximum 1 week from baseline on ]

Secondary Outcome Measures :
  1. self-reported questionnaire for painful [ Time Frame: maximum 1 week from baseline on ]
    Self reported questionnaire with questions to assess the characteristic,intensity of pain on quality of life, and consumption of analgesic.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RA patient will be interviewed par internet questionnaire (patient association / ANDAR)
Criteria

Inclusion Criteria:

  • Rheumatoid arthritis Quarantine

Exclusion Criteria:

  • Non adult patient RA patient without quarantine
Contacts and Locations
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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): NCT04351399


Locations
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France
Hopital Roger Salengro, CHU Lille
Lille, France, 59037
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: René-Marc FLIPO, MD,PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04351399    
Other Study ID Numbers: 2020_29
2020-A00907-32 ( Other Identifier: ID-RCB number,ANSM )
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Psychological impact
COVID-19
Rheumatoid arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Rheumatic Diseases
Collagen Diseases
Chronic Pain
Joint Diseases
 Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations