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Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients (EMOPTION)

Primary Purpose

Covid19, Rheumatic Fever, Mental Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire
blood sample and salivary sample
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Covid19 focused on measuring Covid19, chronic inflammatory rheumatism, stress, Patient reported outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

For the cases:

Inclusion Criteria:

  • 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 :

Inclusion Criteria:

  • 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 :

Exclusion Criteria:

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

Sites / Locations

  • CHU de Bordeaux - service de rhumatologie
  • AP-HP - Hopital Henri Mondor - service de rhumatologie
  • CHRU de Lille - Service de rhumatologie
  • CHU de Montpellier - service de rhumatologie
  • AP-HP - Hopital Cochin - service de rhumatologie
  • CHU de Saint-Etienne - service de rhumatologie
  • CHU de Toulouse - service de rhumatologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patient affected by a chronic inflammatory rheumatism

Controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients affected by depression according to 9-item Patient Health Questionnaire (PHQ-9)
that varies between 0 and 27 with higher values mean greater severity of depression
Proportion of patients affected by anxiety symptoms according to State-Trait Anxiety Inventory questionnaire
that varies between 20 and 80 with higher values mean higher levels of anxiety
Proportion of patients affected by post-traumatic stress disorder symptoms according to Post-traumatic stress disorder Check-List Scale (PCL-S) questionnaire
that varies between 17 and 85 with higher values mean greater intensity of stress disorder
Evaluation of tobacco consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Evaluation of alcohol consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Evaluation of drugs consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Evaluation of CIR treatments compliance continuation compared to the pre-COVID19 pandemic (without any modification, intensification, diminution, discontinuation).
Evaluation of chronic inflammatory rheumatism activity scores using Visual Analog Scale (VAS)
that varies between 0 and 100mm with higher value mean higher value means higher level of disease activity.
Evaluation of the impact of COVID-19 diagnostic on the stress level according to 10-item Perceived Stress Scale (PSS-10)
that varies between 10 and 50 with higher values mean greater difficulties to deal with stress
Evaluation of the impact of COVID-19 diagnostic on CIR activity using Visual Analog Scale (VAS)
that varies between 0 and 100mm with higher value mean higher value means higher level of disease activity
Levels of pro-inflammatory cytokines in sera of CIR patients
TNF-alpha, IL1, IL6, IL10, IL12, IL17, TGF-beta), expressed in UI per milliliter.

Full Information

First Posted
March 10, 2021
Last Updated
March 1, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
Societe Francaise de Rhumatologie
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1. Study Identification

Unique Protocol Identification Number
NCT04798053
Brief Title
Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients
Acronym
EMOPTION
Official Title
Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
December 9, 2022 (Actual)
Study Completion Date
December 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Societe Francaise de Rhumatologie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The previous H1N1 and SRAS-1 pandemics, that required to containment and quarantine, have lead to the emergence of mental symptoms such as stress, anxiety, insomnia… The French COCONEL study during the COVID pandemic have shown the major psychological impact of this crisis on the population, leading to stress and fears. Stressful life events are well-known factors of chronic inflammatory rheumatisms set-up or flare. The aim of this study is therefore to evaluate the psychological impact of COVID-19 pandemic on chronic inflammatory rheumatism (CIR) affected patients. A case-control prospective multicentric study will be performed on 212 CIR patients versus 106 controls to compare the stress level in each group. Patient reported outcomes will be evaluated, using electronic questionnaires, as well as classical clinical informations on CIR evolution during a 6-months follow-up period. An ancillary study on 100 patients will also be realized to quantify cytokine serum levels and determinate transcriptomic profiles.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Rheumatic Fever, Mental Disorder
Keywords
Covid19, chronic inflammatory rheumatism, stress, Patient reported outcomes

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
259 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient affected by a chronic inflammatory rheumatism
Arm Type
Experimental
Arm Description
patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…),
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period
Intervention Type
Behavioral
Intervention Name(s)
Questionnaire
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
blood sample and salivary sample
Intervention Description
10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.
Primary Outcome Measure Information:
Title
Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion
Description
that varies between 10 and 50 with higher values mean greater difficulties to deal with stress
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Secondary Outcome Measure Information:
Title
Proportion of patients affected by depression according to 9-item Patient Health Questionnaire (PHQ-9)
Description
that varies between 0 and 27 with higher values mean greater severity of depression
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Title
Proportion of patients affected by anxiety symptoms according to State-Trait Anxiety Inventory questionnaire
Description
that varies between 20 and 80 with higher values mean higher levels of anxiety
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Title
Proportion of patients affected by post-traumatic stress disorder symptoms according to Post-traumatic stress disorder Check-List Scale (PCL-S) questionnaire
Description
that varies between 17 and 85 with higher values mean greater intensity of stress disorder
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Title
Evaluation of tobacco consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Title
Evaluation of alcohol consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Title
Evaluation of drugs consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Title
Evaluation of CIR treatments compliance continuation compared to the pre-COVID19 pandemic (without any modification, intensification, diminution, discontinuation).
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Title
Evaluation of chronic inflammatory rheumatism activity scores using Visual Analog Scale (VAS)
Description
that varies between 0 and 100mm with higher value mean higher value means higher level of disease activity.
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Title
Evaluation of the impact of COVID-19 diagnostic on the stress level according to 10-item Perceived Stress Scale (PSS-10)
Description
that varies between 10 and 50 with higher values mean greater difficulties to deal with stress
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Title
Evaluation of the impact of COVID-19 diagnostic on CIR activity using Visual Analog Scale (VAS)
Description
that varies between 0 and 100mm with higher value mean higher value means higher level of disease activity
Time Frame
At inclusion (day 0), 3 months and 6 months after inclusion
Title
Levels of pro-inflammatory cytokines in sera of CIR patients
Description
TNF-alpha, IL1, IL6, IL10, IL12, IL17, TGF-beta), expressed in UI per milliliter.
Time Frame
At inclusion (day 0) and 6 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For the cases: Inclusion Criteria: 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 : Inclusion Criteria: 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 : Exclusion Criteria: pregnant or lactating patient psychiatric patient patient under guardianship or other legal protection regimen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry SCHAEVERBEKE, Prof
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux - service de rhumatologie
City
Bordeaux
Country
France
Facility Name
AP-HP - Hopital Henri Mondor - service de rhumatologie
City
Créteil
Country
France
Facility Name
CHRU de Lille - Service de rhumatologie
City
Lille
Country
France
Facility Name
CHU de Montpellier - service de rhumatologie
City
Montpellier
Country
France
Facility Name
AP-HP - Hopital Cochin - service de rhumatologie
City
Paris
Country
France
Facility Name
CHU de Saint-Etienne - service de rhumatologie
City
Saint-Étienne
Country
France
Facility Name
CHU de Toulouse - service de rhumatologie
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients

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