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

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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 14, 2020
First Posted Date April 17, 2020
Last Update Posted Date December 11, 2020
Actual Study Start Date April 27, 2020
Actual Primary Completion Date May 4, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2020)
Frequency of RA patients with emotional impact (feeling of isolation) [ Time Frame: maximum 1 week from baseline on ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 17, 2020)
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.
Original Secondary Outcome Measures
 (submitted: April 16, 2020)
self-reported questionnaire for painful [ Time Frame: maximum 1 week from baseline on ]
Self reported questionnaire with questions to assess the charateristic,intensity of pain on quality of life, and consumption of analgesic.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak
Official Title Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Family-Based
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population RA patient will be interviewed par internet questionnaire (patient association / ANDAR)
Condition
  • Sars-CoV2
  • Rheumatic Diseases
  • Rheumatoid Arthritis
  • Chronic Pain
Intervention Other: questionnaire assesment
The questionnaire will ask questions around their socio-demographic characteristics,quality of life, painful, using analgesic , since they are in quarantine
Study Groups/Cohorts patient with chronic painful inflammatory rheumatism
Intervention: Other: questionnaire assesment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 20, 2020)
318
Original Estimated Enrollment
 (submitted: April 16, 2020)
100
Actual Study Completion Date May 4, 2020
Actual Primary Completion Date May 4, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Rheumatoid arthritis Quarantine

Exclusion Criteria:

  • Non adult patient RA patient without quarantine
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04351399
Other Study ID Numbers 2020_29
2020-A00907-32 ( Other Identifier: ID-RCB number,ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: René-Marc FLIPO, MD,PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date April 2020