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临床试验/NCT04401254
NCT04401254已完成不适用

The Coronavirus Disease 2019 - Recovery Study

Australian and New Zealand Intensive Care Research Centre29 个研究点 分布在 1 个国家目标入组 536 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
536
试验地点
29
主要终点
Disability-free survival

研究概览

简要总结

Patients who are critically ill with COVID-19 requiring life support in an intensive care unit (ICU) have increased risk of morbidity and mortality. Currently the ICU community does not know what effect the disease, the ICU admission, physiotherapy interventions and life support have on their long-term quality of life and whether they can return to their pre-illness level of function following ICU.

COVID-Recovery will describe the physiotherapy interventions delivered to critically ill patients with COVID-19. In survivors, COVID-Recovery will utilise telephone follow-up of ICU survivors to assess disability-free survival and quality of life at 6 months after ICU admission. Additionally, COVID-Recovery will identify if there are predictors of disability-free survival. COVID-Recovery will aim to select up to 300 patients diagnosed with COVID-19 from ICUs in Australia. If they survive to hospital discharge, patients will be invited to receive a telephone questionnaire at 6 months after the ICU admission that aims to assess their long-term outcomes, including physical, cognitive and emotional function, quality of life, and whether they have been able to return to work following ICU discharge.

To describe the experience of critical illness in survivors of COVID-19 and their family members.

To explore and describe functional recovery, respiratory system function and respiratory health morbidity up to 6 months after ICU admission in persistently critically ill adults with 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
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COVID-19 patients who have been admitted to ICU for > 24 hours
  • Patients aged over 17 years
  • Persistent critical illness cohort
  • An ICU admission of at least 10 consecutive days

排除标准

  • Previous enrolment in this study in a prior ICU admission

结局指标

主要结局

Disability-free survival

时间窗: 6 months

a composite measure of WHODAS 2.0 - 12 level and hospital survival

Physiotherapy intervention

时间窗: During the ICU stay until 3 months

The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes

次要结局

  • Cognitive function(6 months)
  • The reported barriers to delivering physiotherapy interventions(During the ICU stay until 28 days)
  • Anxiety and depression(6 months)
  • Adverse events during physiotherapy interventions(During the ICU stay until 28 days)
  • Health status(6 months)
  • Global function(6 months)
  • Proportion of patients with COVID-19 who received physiotherapy in ICU(During the ICU stay until 28 days)
  • Phenomenological data of the patient and family experience(6 months)
  • Screening for post-traumatic distress(6 months)
  • Work Status(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (29)

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