NCT04351399

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

April 27, 2020

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2020

Completed
Last Updated

December 11, 2020

Status Verified

April 1, 2020

Enrollment Period

7 days

First QC Date

April 14, 2020

Last Update Submit

December 10, 2020

Conditions

Keywords

Psychological impactCOVID-19Rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

  • Frequency of RA patients with emotional impact (feeling of isolation)

    maximum 1 week from baseline on

Secondary Outcomes (1)

  • self-reported questionnaire for painful

    maximum 1 week from baseline on

Study Arms (1)

patient with chronic painful inflammatory rheumatism

Other: questionnaire assesment

Interventions

The questionnaire will ask questions around their socio-demographic characteristics,quality of life, painful, using analgesic , since they are in quarantine

patient with chronic painful inflammatory rheumatism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Rheumatoid arthritis Quarantine

You may not qualify if:

  • Non adult patient RA patient without quarantine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Rheumatic DiseasesArthritis, RheumatoidChronic PainCOVID-19

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesArthritisJoint DiseasesAutoimmune DiseasesImmune System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • René-Marc FLIPO, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2020

First Posted

April 17, 2020

Study Start

April 27, 2020

Primary Completion

May 4, 2020

Study Completion

May 4, 2020

Last Updated

December 11, 2020

Record last verified: 2020-04

Locations