Impact of COVID-19 Pandemic and Social Distancing on Mental Health of Chronic Inflammatory Rheumatism Affected Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 259
- 试验地点
- 8
- 主要终点
- Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 :
排除标准
- •pregnant or lactating patient
- •psychiatric patient
- •patient under guardianship or other legal protection regimen.
研究组 & 干预措施
Patient affected by a chronic inflammatory rheumatism
patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…),
干预措施: Questionnaire (Behavioral)
Patient affected by a chronic inflammatory rheumatism
patient affected by a chronic inflammatory rheumatism (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Systemic lupus, Still disease, scleroderma…),
干预措施: blood sample and salivary sample (Biological)
Controls
patient affected by a non-inflammatory or degenerative musculo-skeletal disease during the containment period
干预措施: Questionnaire (Behavioral)
结局指标
主要结局
Change from Baseline stress level according to 10-item Perceived Stress Scale (PSS-10) at 3 months and 6 months after inclusion
时间窗: At inclusion (day 0), 3 months and 6 months after inclusion
that varies between 10 and 50 with higher values mean greater difficulties to deal with stress
次要结局
- Proportion of patients affected by depression according to 9-item Patient Health Questionnaire (PHQ-9)(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(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(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 the impact of COVID-19 diagnostic on CIR activity using Visual Analog Scale (VAS)(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)(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)(At inclusion (day 0), 3 months and 6 months after inclusion)
- Levels of pro-inflammatory cytokines in sera of CIR patients(At inclusion (day 0) 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)