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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00095-36 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Societe Francaise de Rhumatologie | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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…), |
|
| Controls | Active Comparator | patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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For the cases:
Inclusion Criteria:
For controls :
Inclusion Criteria:
For cases and controls :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry SCHAEVERBEKE, Prof | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux - service de rhumatologie | Bordeaux | France | ||||
| AP-HP - Hopital Henri Mondor - service de rhumatologie |
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| blood sample and salivary sample | Biological | 10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases. |
|
that varies between 20 and 80 with higher values mean higher levels of anxiety |
| 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 | that varies between 17 and 85 with higher values mean greater intensity of stress disorder | 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 |
| Evaluation of drugs 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 CIR treatments compliance continuation compared to the pre-COVID19 pandemic (without any modification, intensification, diminution, discontinuation). | At inclusion (day 0), 3 months and 6 months after inclusion |
| 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. | At inclusion (day 0), 3 months and 6 months after inclusion |
| 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 | At inclusion (day 0), 3 months and 6 months after inclusion |
| 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 | At inclusion (day 0), 3 months and 6 months after inclusion |
| Levels of pro-inflammatory cytokines in sera of CIR patients | TNF-alpha, IL1, IL6, IL10, IL12, IL17, TGF-beta), expressed in UI per milliliter. | At inclusion (day 0) and 6 months after inclusion |
| Créteil |
| France |
| CHRU de Lille - Service de rhumatologie | Lille | France |
| CHU de Montpellier - service de rhumatologie | Montpellier | France |
| AP-HP - Hopital Cochin - service de rhumatologie | Paris | France |
| CHU de Saint-Etienne - service de rhumatologie | Saint-Etienne | France |
| CHU de Toulouse - service de rhumatologie | Toulouse | France |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012213 | Rheumatic Fever |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
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