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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04798053
Other study ID # CHUBX 2020/36
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 8, 2021
Est. completion date December 9, 2022

Study information

Verified date March 2023
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 259
Est. completion date December 9, 2022
Est. primary completion date December 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
Questionnaire
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)
Biological:
blood sample and salivary sample
10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.

Locations

Country Name City State
France 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 AP-HP - Hopital Cochin - service de rhumatologie Paris
France CHU de Saint-Etienne - service de rhumatologie Saint-Étienne
France CHU de Toulouse - service de rhumatologie Toulouse

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bordeaux Societe Francaise de Rhumatologie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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 At inclusion (day 0), 3 months and 6 months after inclusion
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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