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

• ClinicalTrials.gov Identifier: NCT04351399
• Recruitment Status: Completed
• First Posted: April 17, 2020
• Last Update Posted: December 11, 2020
• Sponsor: University Hospital, Lille
• 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

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

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

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