Prospective Multicenter Cohort Study to Evaluate Disability Following Hospitalization in People of Working-age Surviving COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Post-acute COVID-19 disability from the care provider's perspective, 12 months after hospitalization
研究概览
简要总结
The purpose of the study is to describe disability following hospitalization in people of working-age surviving COVID-19.
详细描述
In December 2019, the Wuhan Municipal Health Committee in China identified an outbreak with viral pneumonia cases of unknown cause. Coronavirus RNA was identified as the causal agent. The disease caused by SARS-CoV-2 has been named COVID-19. While most people with COVID-19 develop uncomplicated illness, approximately 14% develop severe forms of the disease and 5% are critically ill, potentially leaving survivors with non-fatal sequelae. To date, the long-term burden of COVID-19 and patients' perspectives and needs have been left unaddressed. As compared to 2003 SARS outbreak, one can anticipate persisting disability in COVID-19 survivors, including specific post-COVID and non-specific post-intensive care syndromes. The investigators hypothesize that dramatic COVID-19-specific and non-specific mid- and long-term disabilities would persist in people surviving COVID-19.
The main objective will be to provide a deep understanding of non-fatal health outcomes in people surviving COVID-19, by comprehensively and systematically mapping and monitoring, within the WHO ICF framework, disability levels and profiles, in the mid and long terms in people surviving COVID-19.
Disability levels will be assessed at 12 (±7) and 36 (±3) months using:
- Parts 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider, and
- Self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
A. The secondary objectives will be to describe COVID-19 specific and non-specific impairments, activity limitations and participation restriction at 12 (±7) and 36 (±3) months in people surviving COVID-19:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of working-age (18 to 70 years),
- •Hospitalization during the prespecified inclusion period (from March 2020 to March 2021) (NB : in case of transferred patients, inclusion in the DisCOVID study must be carried out in the first place of admission for COVID),
- •Laboratory-confirmed SARS-CoV-2 and/or CT-scan showing typical radiological findings,
- •SARS-CoV-2 of any duration,
- •Ability to comply with study visits,
- •Informed written consent
排除标准
- •Return home in less than 72 hours
- •Absence of health insurance,
- •Inability to fluently speak and/or read French language,
- •People under tutorship or curatorship and protected adults.
结局指标
主要结局
Post-acute COVID-19 disability from the care provider's perspective, 12 months after hospitalization
时间窗: At 12 (±7) months after hospitalization
Disability levels will be assessed using Part 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider.
Post-acute COVID-19 disability from the care provider's perspective, 36 months after hospitalization
时间窗: 36 (±3) months after hospitalization
Disability levels will be assessed using Part 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider
Post-acute COVID-19 disability from the patient's perspectives, 12 months after hospitalization
时间窗: At 12 (±7) months after hospitalization
Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Post-acute COVID-19 disability from the patient's perspectives, 36 months after hospitalization
时间窗: 36 (±3) months after hospitalization
Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
次要结局
- Work Ability (questionnaire self-administered on ComPARe IT dedicated platform)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Work productivity (questionnaire self-administered on ComPARe IT dedicated platform)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Comorbidities (score completed by the investigator during a face-to-face visit)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Impairments, activity limitations and participation restrictions (checklist completed by the investigator during a face-to-face visit)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Mobility test to assess the consequences of neurological, cardiorespiratory, osteoarticular or respiratory impairments (clinical assessment by the investigator during a face-to-face visit)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Locomotor impairments (clinical assessment by the investigator during a face-to-face visit)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Upper extremities impairments (clinical assessment by the investigator during a face-to-face visit)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Respiratory impairment (clinical assessment by the investigator during a face-to-face visit)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Resource utilization(Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.)
- Symptoms of anxiety and/or depression of participant's close relative(Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.)
- Symptoms of post-traumatic stress(Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.)
- Cognitive impairments (clinical assessment by the investigator during a face-to-face visit)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Muscular impairments (clinical assessment by the investigator during a face-to-face visit)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Respiratory impairments (clinical assessment by the investigator during a face-to-face visit)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Total costs(12 (±7) and 36 (±3) months after the first day of the first hospitalization)
- Costs drivers(12 (±7) and 36 (±3) months after the first day of the first hospitalization)
- Estimated Years lived with Disability(12 (±7) and 36 (±3) months after the first day of the first hospitalization)
- Type of treatments(At 12 (±7) and 36 (±3) months after hospitalization)
- Acceptable symptom state (questionnaire self-administered on ComPARe IT dedicated platform)(12(±7) and 36 (±3) months after the first day of the first hospitalization.)
- Health-related quality of life (questionnaire self-administered on ComPARe IT dedicated platform)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Pain (questionnaire self-administered on ComPARe IT dedicated platform)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Impairments, activity limitations and participation restrictions, health-related quality of life Fatigue (questionnaire self-administered on ComPARe IT dedicated platform)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)(12 (±7), and 36 (±3) months after the first day of the first hospitalization.)
- Urinary symptoms, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Burden of post-acute COVID-19 on participant's close relative(Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.)
- Female sexual dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Erectile dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)
- Global activity limitations and participation restrictions (questionnaire self-administered on ComPARe IT dedicated platform)(12 (±7) and 36 (±3) months after the first day of the first hospitalization.)