Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With COVID-19 Infection in the Hauts de France Region (COCO_Vi_LATE)
Coordinated Research on Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With SARS-COV-2 Infection: a Transversal Study in Town in the Hauts de France Region
Several publications document the occurrence of prolonged or late-onset symptoms beyond 3 weeks after the first clinical manifestations of SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory events or other mechanisms that are not yet well understood. The psychosomatic origin secondary to psychiatric disorders prior to the infection or in reaction to it is also to be evoked. The identification of the clinical manifestations observed, and their clinical and paraclinical evolution are essential to better understand the natural evolution of COVID-19, to specify the physiopathological mechanisms and to identify potential avenues of management for the patients. In addition, the impact of COVID-19 infection on primary care visits is not known. In general practice, these patients benefit from explorations and even diagnoses that may explain the persistence of symptoms (autoimmune diseases, thrombosis, somatoform disorders, hyperventilation syndrome, etc.).
The objective of the COCO_Vi_LATE project is to carry out a cross-sectional study of patients presenting persistent and/or recurrent symptoms after an infection with SARS-COV-2 who will be compared to individuals with a short form of infection with COVID-19
研究概览
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Olivier ROBINEAU, MD
- 电话号码:0320694949
- 邮箱:orobineau@ch-tourcoing.fr
学习地点
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Tourcoing、法国
- 招聘中
- CH Tourcoing
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
A- For COVID cases:
- Consultation in a city doctor's office
- Positive SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology
- Patient symptomatic or not
Definition of symptomatic :
- Anosmia
- OR CT scan suggestive of COVID 19
- OR ≥ 2 symptoms contemporaneous with virologic sampling among: asthenia, cough, dyspnea, fever, myalgias, dysgeusia, diarrhea AND not present previously at diagnosis
B-. For NON COVID cases:
- Consultation in a city doctor's office
- No known COVID+ serology
- No known RT- PCR SARS-CoV-2
- No clinical suspicion of COVID-19 infection
Exclusion Criteria:
- Minor patient
- Refusal to participate
- Patient under protection
- Patient requiring hospitalization for COVID-19 (excluding non-emergency hospitalization)
- Patient consulted for the following reason only: treatment monitoring, treatment renewal or certificate, hospital discharge
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
队列和干预
团体/队列 |
干预/治疗 |
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COVID-19阳性
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Questionnaire SSD-12 and EQ5D5L
Medical consultation during the visit with data collection
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COVID-19 阴性
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Questionnaire SSD-12 and EQ5D5L
Medical consultation during the visit with data collection
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To compare the reasons for consultation between patients with a history of Covid 19 and those who have not been infected with SARS-CoV-2.
大体时间:At day 1
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The judgement criterion will be the reasons for consultation standardized with the CISP-2 classification (International Classification of Primary Care).
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At day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients.
大体时间:At day 1
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The assessment will be done using the international SSD-12 scale (Symptom Disorder-B Criteria Scale).
The SSD-12 is composed of 12 items; each of the three psychological subcriteria is measured by four items (cognitive aspects; affective aspects; behavioral aspects).
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At day 1
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To compare the quality of life of COVID-19 patients with that of non-COVID-19 patients.
大体时间:At day 1
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The EQ-5D-5L scale is composed of - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale (EQ VAS).
The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression).
Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Each level corresponds to 1-digit number expressing the level selected for that dimension.The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'.
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At day 1
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合作者和调查者
调查人员
- 首席研究员:Olivier ROBINEAU, MD、CH Tourcoing
- 首席研究员:Sophie PANAGET, MD、CHRU Lille
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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