NCT04609839撤回不适用
TeleRea'nCo : FOLLOW-UP OF PATIENTS WITH COVID-19.
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The presence of respiratory, renal, cardiac, motor, neurological, and psychological sequelae will be assessed by specialist doctors during the 12 months following the patient's discharge from intensive care.
研究概览
简要总结
Some patients admitted to intensive care for a severe form of COVID-19 could have respiratory, cardiac, renal and neurological sequelae in the medium or long term.
The results of this research will allow an improvement in the understanding and management of patients in the medium and long term.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient admitted to intensive care unit for COVID-19
- •Adult patient ≥ 18 years old
- •Subject having expressed his non-opposition to the research
- •Subject affiliated to a social health insurance protection scheme or beneficiary of such a scheme
排除标准
- •Subject under safeguard of justice
- •Patient under guardianship or curatorship
结局指标
主要结局
The presence of respiratory, renal, cardiac, motor, neurological, and psychological sequelae will be assessed by specialist doctors during the 12 months following the patient's discharge from intensive care.
时间窗: The primary endpoint will be measured during 12 months following the patient's discharge from intensive care.
次要结局
- 4.1) Quality of life score (SF-36 questionnaire) at 3, 6 and 12 months(At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion)
- 3) Date of death(Date of death will be collected from inclusion to M12 (12 months after patient inclusion))
- 5) Cost of health expenditure(The cost of health expenditure will be collected from inclusion to M12 (12 months after patient inclusion))
- 1) The sequelae by type of impairment will be assessed by specialist doctors at 3, 6 and 12 months(At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion)
- 2) Number of re-hospitalizations at 3, 6 and 12 months(At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion)
- 4.2) The Pittsburgh sleep quality index (PSQI questionnaire) at 3, 6 and 12 months(At M3 (+/-15 days) : 3 months after patient inclusion-At M6 (+/-15 days) : 6 months after patient inclusion-At M12 (+/-15 days) : 12 months after patient inclusion)
研究者
研究点 (1)
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