Clinical trial NCT04798053: Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients
Official title: Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Rheumatic Fever
Mental Disorder
Keywords: Covid19
chronic inflammatory rheumatism
stress
Patient reported outcomes
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Societe Francaise de Rhumatologie
First posted: 2021-03-15
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
Secondary outcomes:
measure: Proportion of patients affected by depression according to 9-item Patient Health Questionnaire (PHQ-9)
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
measure: Proportion of patients affected by anxiety symptoms according to State-Trait Anxiety Inventory questionnaire
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
measure: Proportion of patients affected by post-traumatic stress disorder symptoms according to Post-traumatic stress disorder Check-List Scale (PCL-S) questionnaire
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
measure: Evaluation of tobacco consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
measure: Evaluation of alcohol consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
measure: Evaluation of drugs consumption evolution compared to the pre-COVID19 pandemic (less, same or more)
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
measure: Evaluation of CIR treatments compliance continuation compared to the pre-COVID19 pandemic (without any modification, intensification, diminution, discontinuation).
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
measure: Evaluation of chronic inflammatory rheumatism activity scores using Visual Analog Scale (VAS)
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
measure: Evaluation of the impact of COVID-19 diagnostic on the stress level according to 10-item Perceived Stress Scale (PSS-10)
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
measure: Evaluation of the impact of COVID-19 diagnostic on CIR activity using Visual Analog Scale (VAS)
timeFrame: At inclusion (day 0), 3 months and 6 months after inclusion
measure: Levels of pro-inflammatory cytokines in sera of CIR patients
timeFrame: At inclusion (day 0) and 6 months after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - service de rhumatologie
city: Créteil
country: France
facility: AP-HP - Hopital Henri Mondor - service de rhumatologie
city: Lille
country: France
facility: CHRU de Lille - Service de rhumatologie
city: Montpellier
country: France
facility: CHU de Montpellier - service de rhumatologie
city: Paris
country: France
facility: AP-HP - Hopital Cochin - service de rhumatologie
city: Saint-Étienne
country: France
facility: CHU de Saint-Etienne - service de rhumatologie
city: Toulouse
country: France
facility: CHU de Toulouse - service de rhumatologie
Study officials:
affiliation: University Hospital, Bordeaux
name: Thierry SCHAEVERBEKE, Prof
role: PRINCIPAL_INVESTIGATOR
References: