Psychological Impact of Quarantine in Rheumatoid Arthriti... | NCT04351399

Studies
Psychological Impact of Quarantine in Rheumatoid Arthritis Patient During COVID-19 Outbreak

NCT04351399

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Dec 11, 2020Actual

Enrollment

318Actual

Phase

Not provided

Conditions

Sars-CoV2
Rheumatic Diseases
Rheumatoid Arthritis
Chronic Pain

Interventions

questionnaire assesment

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A00907-32	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 27, 2020Actual

Primary Completion Date

May 4, 2020Actual

Completion Date

May 4, 2020Actual

First Submitted Date

Apr 14, 2020

First Submission Date that Met QC Criteria

Apr 16, 2020

First Posted Date

Apr 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2020

Last Update Posted Date

Dec 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

318Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patient with chronic painful inflammatory rheumatism			Other: questionnaire assesment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire assesment	Other	The questionnaire will ask questions around their socio-demographic characteristics,quality of life, painful, using analgesic , since they are in quarantine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
self-reported questionnaire for painful	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rheumatoid arthritis Quarantine

Exclusion Criteria:

Non adult patient RA patient without quarantine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
René-Marc FLIPO, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Roger Salengro, CHU Lille		Lille		59037	France

Condition Browse Module

MeSH Terms

ID	Term
D012216	Rheumatic Diseases
D001172	Arthritis, Rheumatoid
D059350	Chronic Pain
D000086382	COVID-19

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001168	Arthritis

Browse Leaves

Not provided

Browse Branches

Not provided