Recovery of Patients From COVID-19 After Critical Illness

Completed

• Conditions: Critical Illness; COVID-19

• Registration Number: NCT04401254
• Lead Sponsor: Australian and New Zealand Intensive Care Research Centre

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-07
• Study First Submitted QC: 2020-05-22
• Study First Posted: 2020-05-26
• Study Start: 2020-07-01
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 536

Inclusion Criteria

1. COVID-19 patients who have been admitted to ICU for > 24 hours
2. Patients aged over 17 years

Persistent critical illness cohort

1. As above
2. An ICU admission of at least 10 consecutive days

Exclusion Criteria

• Previous enrolment in this study in a prior ICU admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability-free survival	6 months	a composite measure of WHODAS 2.0 - 12 level and hospital survival
Physiotherapy intervention	During the ICU stay until 3 months	The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes

Secondary Outcome Measures

Name	Time	Method
Cognitive function	6 months	Montreal Cognitive Assessment Blind
Screening for post-traumatic distress	6 months	Impact of Events Scale Revised
The reported barriers to delivering physiotherapy interventions	During the ICU stay until 28 days	Physiotherapist reported barriers to delivering the intervention
Anxiety and depression	6 months	Hospital Anxiety and Depression Scale
Adverse events during physiotherapy interventions	During the ICU stay until 28 days	Adverse events that require the intervention to be ceased for medical intervention
Health status	6 months	Health related quality of life measured with EQ5D-5L score from 0 to 100
Global function	6 months	Global Rating of Change
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	Qualitative interviews
Work Status	6 months	WHODAS 2.0

Trial Locations

Locations (29)

Canberra Hospital; 🇦🇺 Garran, Australian Capital Territory, Australia

Royal Prince Alfred Hospital; 🇦🇺 Camperdown, New South Wales, Australia

Concord Hospital; 🇦🇺 Concord, New South Wales, Australia

St Vincent's Hospital Sydney; 🇦🇺 Darlinghurst, New South Wales, Australia

Nepean Hospital; 🇦🇺 Kingswood, New South Wales, Australia

St George Hospital; 🇦🇺 Kogarah, New South Wales, Australia

John Hunter Hospital; 🇦🇺 New Lambton Heights, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 Saint Leonards, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

The Prince Charles Hospital; 🇦🇺 Chermside, Queensland, Australia

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