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
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Olivier ROBINEAU, MD
- 전화번호: 0320694949
- 이메일: orobineau@ch-tourcoing.fr
연구 장소
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-
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Tourcoing, 프랑스
- 모병
- Ch Tourcoing
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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COVID-19 양성
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Questionnaire SSD-12 and EQ5D5L
Medical consultation during the visit with data collection
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COVID-19 음성
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Questionnaire SSD-12 and EQ5D5L
Medical consultation during the visit with data collection
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To Assess the presence of somatoform disorders between COVID-19 and non-COVID-19 patients.
기간: 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.
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Olivier ROBINEAU, MD, Ch Tourcoing
- 수석 연구원: Sophie PANAGET, MD, CHRU Lille
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RIPH_2021_01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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