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Recovery of Patients From COVID-19 After Critical Illness (COVID-Recovery)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04401254
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
The Alfred
Information provided by (Responsible Party):
Australian and New Zealand Intensive Care Research Centre

Study Description
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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.

COVID-Recovery will also aim to investigate the human aspect of COVID-19 by further investigating a sub-set of patients. COVID-Recovery will recruit between 15-30 of these patients and a family member, so COVID-Recovery can explore the patient experience of being admitted to the ICU and treated for COVID-19, as well as illuminate and explore the experience of having a close relative admitted and treated for COVID-19.


Condition or disease
COVID-19 Critical Illness

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The COVID-Recovery Study
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : April 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Disability-free survival [ Time Frame: 6 months ]
    a composite measure of WHODAS 2.0 - 12 level and hospital survival

  2. 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 Outcome Measures :
  1. Health status [ Time Frame: 6 months ]
    Health related quality of life measured with EQ5D-5L score from 0 to 100

  2. Global function [ Time Frame: 6 months ]
    World Health Organization Disability Assessment Schedule 2.0 12L

  3. Cognitive function [ Time Frame: 6 months ]
    Montreal Cognitive Assessment Blind

  4. Anxiety and depression [ Time Frame: 6 months ]
    Hospital Anxiety and Depression Scale

  5. Screening for post-traumatic distress [ Time Frame: 6 months ]
    Impact of Events Scale Revised

  6. Work Status [ Time Frame: 6 months ]
    WHODAS 2.0

  7. Proportion of patients with COVID-19 who received physiotherapy in ICU [ Time Frame: During the ICU stay until 28 days ]
  8. The reported barriers to delivering physiotherapy interventions [ Time Frame: During the ICU stay until 28 days ]
    Physiotherapist reported barriers to delivering the intervention

  9. Adverse events during physiotherapy interventions [ Time Frame: During the ICU stay until 28 days ]
    Adverse events that require the intervention to be ceased for medical intervention

  10. Phenomenological data of the patient and family experience [ Time Frame: 6 months ]
    Qualitative interviews


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critically ill patients with COVID-19 admitted to an intensive care unit
Criteria

Inclusion Criteria:

  1. COVID-19 patients who have been admitted to ICU for > 24 hours
  2. Patients aged over17 years

Exclusion Criteria:

  • Previous enrolment in this study in a prior ICU admission
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401254


Contacts
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Contact: Carol Hodgson, PhD +61448674532 carol.hodgson@monash.edu
Contact: Natalie Linke, RN natalie.link@monash.edu

Locations
Show Show 33 study locations
Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
The Alfred
More Information
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Responsible Party: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT04401254    
Other Study ID Numbers: COVID-Recovery V1.0 01May2020
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be shared if approved by the steering committee and with ethical approvals.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 12 months after completion of the study for 12 months
Access Criteria: Email the Chief Investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Australian and New Zealand Intensive Care Research Centre:
recovery
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes