Clinical trial NCT04401254: Recovery of Patients From COVID-19 After Critical Illness
Official title: The Coronavirus Disease 2019 - Recovery Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Critical Illness
Keywords: recovery
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: The Alfred
First posted: 2020-05-26
Enrollment: 536
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients with COVID-19 admitted to an intensive care unit

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


Eligibility criteria: 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

Primary outcomes:
measure: Disability-free survival
timeFrame: 6 months
measure: Physiotherapy intervention
timeFrame: During the ICU stay until 3 months
Secondary outcomes:
measure: Health status
timeFrame: 6 months
measure: Global function
timeFrame: 6 months
measure: Cognitive function
timeFrame: 6 months
measure: Anxiety and depression
timeFrame: 6 months
measure: Screening for post-traumatic distress
timeFrame: 6 months
measure: Work Status
timeFrame: 6 months
measure: Proportion of patients with COVID-19 who received physiotherapy in ICU
timeFrame: During the ICU stay until 28 days
measure: The reported barriers to delivering physiotherapy interventions
timeFrame: During the ICU stay until 28 days
measure: Adverse events during physiotherapy interventions
timeFrame: During the ICU stay until 28 days
measure: Phenomenological data of the patient and family experience
timeFrame: 6 months
measure: Global function
timeFrame: 6 months
Other outcomes:
Locations:
city: Garran
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Concord
country: Australia
facility: Concord Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital Sydney
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: New Lambton Heights
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Saint Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Redcliffe
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Launceston
country: Australia
facility: Launceston Hospital
state: Tasmania
city: Berwick
country: Australia
facility: Casey Hospital
state: Victoria
city: Box Hill
country: Australia
facility: Box Hill Hospital (Eastern Health)
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Dandenong
country: Australia
facility: Dandenong Hospital
state: Victoria
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Frankston
country: Australia
facility: Frankston Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Health
state: Victoria
city: Melbourne
country: Australia
facility: Australian New Zealand Intensive Care Research Centre
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Prahran
country: Australia
facility: Alfred Hospital
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
Study officials:
affiliation: Monash University
name: Carol Hodgson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.