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Clinical Trials/NCT04401254
NCT04401254
Completed
N/A

The Coronavirus Disease 2019 - Recovery Study

Australian and New Zealand Intensive Care Research Centre29 sites in 1 country536 target enrollmentJuly 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
COVID-19
Sponsor
Australian and New Zealand Intensive Care Research Centre
Enrollment
536
Locations
29
Primary Endpoint
Disability-free survival
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
July 1, 2020
End Date
July 30, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Previous enrolment in this study in a prior ICU admission

Outcomes

Primary Outcomes

Disability-free survival

Time Frame: 6 months

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

Physiotherapy intervention

Time Frame: During the ICU stay until 3 months

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

Secondary Outcomes

  • 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)

Study Sites (29)

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