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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
259
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)
10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.
CHU de Bordeaux - service de rhumatologie
Bordeaux, France
AP-HP - Hopital Henri Mondor - service de rhumatologie
Créteil, France
CHRU de Lille - Service de rhumatologie
Lille, France
CHU de Montpellier - service de rhumatologie
Montpellier, France
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
Time frame: At inclusion (day 0), 3 months and 6 months after inclusion
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
Time frame: 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
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
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
Time frame: 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)
Time frame: 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)
Time frame: 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)
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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
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At inclusion (day 0) and 6 months after inclusion