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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04401254
Registration number
NCT04401254
Ethics application status
Date submitted
7/05/2020
Date registered
26/05/2020
Titles & IDs
Public title
Recovery of Patients From COVID-19 After Critical Illness
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Scientific title
The Coronavirus Disease 2019 - Recovery Study
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Secondary ID [1]
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COVID-Recovery V1.5 9Feb2022
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19
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Critical Illness
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disability-free survival
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Assessment method [1]
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a composite measure of WHODAS 2.0 - 12 level and hospital survival
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Timepoint [1]
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6 months
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Primary outcome [2]
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Physiotherapy intervention
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Assessment method [2]
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The physiotherapy interventions provided to patients with COVID-19 admitted to the ICU and health outcomes
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Timepoint [2]
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During the ICU stay until 3 months
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Secondary outcome [1]
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Health status
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Assessment method [1]
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Health related quality of life measured with EQ5D-5L score from 0 to 100
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Global function
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Assessment method [2]
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World Health Organization Disability Assessment Schedule 2.0 12L
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Cognitive function
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Assessment method [3]
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Montreal Cognitive Assessment Blind
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Timepoint [3]
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6 months
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Secondary outcome [4]
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Anxiety and depression
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Assessment method [4]
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Hospital Anxiety and Depression Scale
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Timepoint [4]
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6 months
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Secondary outcome [5]
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Screening for post-traumatic distress
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Assessment method [5]
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Impact of Events Scale Revised
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Timepoint [5]
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6 months
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Secondary outcome [6]
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Work Status
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Assessment method [6]
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WHODAS 2.0
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Timepoint [6]
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6 months
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Secondary outcome [7]
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Proportion of patients with COVID-19 who received physiotherapy in ICU
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Assessment method [7]
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Timepoint [7]
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During the ICU stay until 28 days
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Secondary outcome [8]
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The reported barriers to delivering physiotherapy interventions
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Assessment method [8]
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Physiotherapist reported barriers to delivering the intervention
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Timepoint [8]
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During the ICU stay until 28 days
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Secondary outcome [9]
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Adverse events during physiotherapy interventions
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Assessment method [9]
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Adverse events that require the intervention to be ceased for medical intervention
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Timepoint [9]
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During the ICU stay until 28 days
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Secondary outcome [10]
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Phenomenological data of the patient and family experience
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Assessment method [10]
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Qualitative interviews
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Timepoint [10]
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6 months
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Secondary outcome [11]
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Global function
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Assessment method [11]
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Global Rating of Change
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Timepoint [11]
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6 months
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Eligibility
Key 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
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Minimum age
17
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Previous enrolment in this study in a prior ICU admission
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/07/2022
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Sample size
Target
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Accrual to date
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Final
536
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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Canberra Hospital - Garran
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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Concord Hospital - Concord
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Recruitment hospital [4]
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St Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [5]
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Nepean Hospital - Kingswood
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Recruitment hospital [6]
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St George Hospital - Kogarah
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Recruitment hospital [7]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [8]
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Royal North Shore Hospital - Saint Leonards
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Recruitment hospital [9]
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Westmead Hospital - Westmead
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Recruitment hospital [10]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [11]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [12]
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Redcliffe Hospital - Redcliffe
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Recruitment hospital [13]
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Gold Coast Hospital - Southport
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Recruitment hospital [14]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [15]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [16]
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Launceston Hospital - Launceston
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Recruitment hospital [17]
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Casey Hospital - Berwick
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Recruitment hospital [18]
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Box Hill Hospital (Eastern Health) - Box Hill
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Recruitment hospital [19]
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Monash Medical Centre - Clayton
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Recruitment hospital [20]
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Dandenong Hospital - Dandenong
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Recruitment hospital [21]
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St Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [22]
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Footscray Hospital - Footscray
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Recruitment hospital [23]
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Frankston Hospital - Frankston
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Recruitment hospital [24]
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Austin Hospital - Heidelberg
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Recruitment hospital [25]
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Cabrini Health - Malvern
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Recruitment hospital [26]
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Australian New Zealand Intensive Care Research Centre - Melbourne
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Recruitment hospital [27]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [28]
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Alfred Hospital - Prahran
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Recruitment hospital [29]
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Sunshine Hospital - St Albans
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2139 - Concord
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Recruitment postcode(s) [4]
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2010 - Darlinghurst
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Recruitment postcode(s) [5]
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2747 - Kingswood
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Recruitment postcode(s) [6]
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2217 - Kogarah
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Recruitment postcode(s) [7]
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2305 - New Lambton Heights
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Recruitment postcode(s) [8]
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2065 - Saint Leonards
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Recruitment postcode(s) [9]
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2145 - Westmead
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Recruitment postcode(s) [10]
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4032 - Chermside
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Recruitment postcode(s) [11]
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4029 - Herston
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Recruitment postcode(s) [12]
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4020 - Redcliffe
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Recruitment postcode(s) [13]
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4215 - Southport
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Recruitment postcode(s) [14]
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4102 - Woolloongabba
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Recruitment postcode(s) [15]
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5000 - Adelaide
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Recruitment postcode(s) [16]
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7250 - Launceston
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Recruitment postcode(s) [17]
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3806 - Berwick
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Recruitment postcode(s) [18]
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3128 - Box Hill
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Recruitment postcode(s) [19]
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3168 - Clayton
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Recruitment postcode(s) [20]
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3175 - Dandenong
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Recruitment postcode(s) [21]
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3065 - Fitzroy
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Recruitment postcode(s) [22]
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3011 - Footscray
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Recruitment postcode(s) [23]
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3199 - Frankston
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Recruitment postcode(s) [24]
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3084 - Heidelberg
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Recruitment postcode(s) [25]
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3144 - Malvern
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Recruitment postcode(s) [26]
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3004 - Melbourne
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Recruitment postcode(s) [27]
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3050 - Parkville
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Recruitment postcode(s) [28]
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3004 - Prahran
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Recruitment postcode(s) [29]
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3021 - St Albans
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Funding & Sponsors
Primary sponsor type
Other
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Name
Australian and New Zealand Intensive Care Research Centre
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Alfred
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT04401254
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Trial related presentations / publications
Hodgson CL, Higgins AM, Bailey MJ, Mather AM, Beach L, Bellomo R, Bissett B, Boden IJ, Bradley S, Burrell A, Cooper DJ, Fulcher BJ, Haines KJ, Hodgson IT, Hopkins J, Jones AYM, Lane S, Lawrence D, van der Lee L, Liacos J, Linke NJ, Gomes LM, Nickels M, Ntoumenopoulos G, Myles PS, Patman S, Paton M, Pound G, Rai S, Rix A, Rollinson TC, Tipping CJ, Thomas P, Trapani T, Udy AA, Whitehead C, Anderson S, Neto AS; COVID-Recovery Study Investigators and the ANZICS Clinical Trials Group. Comparison of 6-Month Outcomes of Survivors of COVID-19 versus Non-COVID-19 Critical Illness. Am J Respir Crit Care Med. 2022 May 15;205(10):1159-1168. doi: 10.1164/rccm.202110-2335OC. Erratum In: Am J Respir Crit Care Med. 2022 Sep 1;206(5):653. doi: 10.1164/rccm.v206erratum7. Hodgson CL, Higgins AM, Bailey MJ, Mather AM, Beach L, Bellomo R, Bissett B, Boden IJ, Bradley S, Burrell A, Cooper DJ, Fulcher BJ, Haines KJ, Hopkins J, Jones AYM, Lane S, Lawrence D, van der Lee L, Liacos J, Linke NJ, Gomes LM, Nickels M, Ntoumenopoulos G, Myles PS, Patman S, Paton M, Pound G, Rai S, Rix A, Rollinson TC, Sivasuthan J, Tipping CJ, Thomas P, Trapani T, Udy AA, Whitehead C, Hodgson IT, Anderson S, Neto AS; COVID-Recovery Study Investigators and the ANZICS Clinical Trials Group. The impact of COVID-19 critical illness on new disability, functional outcomes and return to work at 6 months: a prospective cohort study. Crit Care. 2021 Nov 8;25(1):382. doi: 10.1186/s13054-021-03794-0.
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Public notes
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Contacts
Principal investigator
Name
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Carol Hodgson, PhD
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Address
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Monash University
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
IPD will be shared if approved by the steering committee and with ethical approvals.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
12 months after completion of the study for 12 months
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Available to whom?
Email the Chief Investigator
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04401254