Recovery of Patients From COVID-19 After Critical Illness (COVID-Recovery)
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|ClinicalTrials.gov Identifier: NCT04401254|
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : October 23, 2020
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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
- 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
- Health status [ Time Frame: 6 months ]Health related quality of life measured with EQ5D-5L score from 0 to 100
- Global function [ Time Frame: 6 months ]World Health Organization Disability Assessment Schedule 2.0 12L
- Cognitive function [ Time Frame: 6 months ]Montreal Cognitive Assessment Blind
- Anxiety and depression [ Time Frame: 6 months ]Hospital Anxiety and Depression Scale
- Screening for post-traumatic distress [ Time Frame: 6 months ]Impact of Events Scale Revised
- Work Status [ Time Frame: 6 months ]WHODAS 2.0
- Proportion of patients with COVID-19 who received physiotherapy in ICU [ Time Frame: During the ICU stay until 28 days ]
- The reported barriers to delivering physiotherapy interventions [ Time Frame: During the ICU stay until 28 days ]Physiotherapist reported barriers to delivering the intervention
- 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
- Phenomenological data of the patient and family experience [ Time Frame: 6 months ]Qualitative interviews
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
|Contact: Carol Hodgson, PhDemail@example.com|
|Contact: Natalie Linke, RNfirstname.lastname@example.org|