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

December 10, 2020 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • Hopital Roger Salengro, CHU Lille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

RA patient will be interviewed par internet questionnaire (patient association / ANDAR)

Description

Inclusion Criteria:

  • Rheumatoid arthritis Quarantine

Exclusion Criteria:

  • Non adult patient RA patient without quarantine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of RA patients with emotional impact (feeling of isolation)
Time Frame: maximum 1 week from baseline on
maximum 1 week from baseline on

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
maximum 1 week from baseline on

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: René-Marc FLIPO, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Actual)

May 4, 2020

Study Completion (Actual)

May 4, 2020

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 16, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

December 11, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_29
  • 2020-A00907-32 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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