NCT04798053

Brief Summary

Recent studies have highlighted the consequences of COVID-19 pandemic and social distancing on mental health of individuals. The aim of this study is to evaluate those consequences within a sample of inflammatory chronic rheumatism affected patients, taking into account the well-known key role of stress in the set-up of such diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
259

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

7 active sites

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

March 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 15, 2021

Completed
24 days until next milestone

Study Start

First participant enrolled

April 8, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2022

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

1.7 years

First QC Date

March 10, 2021

Last Update Submit

March 1, 2023

Conditions

Covid19Rheumatic FeverMental Disorder

Keywords

Covid19chronic inflammatory rheumatismstressPatient reported outcomes

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion

    that varies between 10 and 50 with higher values mean greater difficulties to deal with stress

    At inclusion (day 0), 3 months and 6 months after inclusion

Secondary Outcomes (11)

  • Proportion of patients affected by depression according to 9-item Patient Health Questionnaire (PHQ-9)

    At inclusion (day 0), 3 months and 6 months after inclusion

  • Proportion of patients affected by anxiety symptoms according to State-Trait Anxiety Inventory questionnaire

    At inclusion (day 0), 3 months and 6 months after inclusion

  • Proportion of patients affected by post-traumatic stress disorder symptoms according to Post-traumatic stress disorder Check-List Scale (PCL-S) questionnaire

    At inclusion (day 0), 3 months and 6 months after inclusion

  • Evaluation of tobacco consumption evolution compared to the pre-COVID19 pandemic (less, same or more)

    At inclusion (day 0), 3 months and 6 months after inclusion

  • Evaluation of alcohol consumption evolution compared to the pre-COVID19 pandemic (less, same or more)

    At inclusion (day 0), 3 months and 6 months after inclusion

  • +6 more secondary outcomes

Study Arms (2)

Patient affected by a chronic inflammatory rheumatism

EXPERIMENTAL

patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…),

Behavioral: QuestionnaireBiological: blood sample and salivary sample

Controls

ACTIVE COMPARATOR

patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

14-item Perceived Stress Scale (PSS-14), 9-item Patient Health Questionnaire (PHQ-9 questionnaire), State Trait Inventory Anxiety questionnaire (STAI questionnaire), Post-traumatic Stress Disorder Checklist Scale (PCL-S questionnaire)

ControlsPatient affected by a chronic inflammatory rheumatism
blood sample and salivary sampleBIOLOGICAL

10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.

Patient affected by a chronic inflammatory rheumatism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patient (age over 18 years old)
  • patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…)
  • patient without any language difficulty
  • affiliated to an health insurance system
  • and who agree to participate in the study
  • For controls :
  • adult patient (age over 18 years ol
  • patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period,
  • patient without any language difficulty,
  • affiliated to an health insurance system,
  • and who agree to participate in the study.
  • For cases and controls :

You may not qualify if:

  • pregnant or lactating patient
  • psychiatric patient
  • patient under guardianship or other legal protection regimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

Location

AP-HP - Hopital Henri Mondor - service de rhumatologie

Créteil, France

Location

CHRU de Lille - Service de rhumatologie

Lille, France

Location

CHU de Montpellier - service de rhumatologie

Montpellier, France

Location

AP-HP - Hopital Cochin - service de rhumatologie

Paris, France

Location

CHU de Saint-Etienne - service de rhumatologie

Saint-Etienne, France

Location

CHU de Toulouse - service de rhumatologie

Toulouse, France

Location

MeSH Terms

Conditions

COVID-19Rheumatic FeverMental Disorders

Interventions

Surveys and QuestionnairesBlood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, Operative

Study Officials

  • Thierry SCHAEVERBEKE, Prof

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 15, 2021

Study Start

April 8, 2021

Primary Completion

December 9, 2022

Study Completion

December 9, 2022

Last Updated

March 2, 2023

Record last verified: 2023-03

Locations

FR(7)