This study is a prospective cohort study to evaluate the long-term effects of early activity and mobilisation compared to standard care on disability, function and health status for patients at 1, 2 and 5 years after recruitment of patients randomised into the TEAM Phase III RCT (ClinicalTrials.gov NCT03133377). The primary outcome of the study will be the level of disability as measured by the World Health Organisation's Disability Schedule 2.0, 12 level (WHODAS) at 2 years after recruitment.
Incomplete recovery following critical illness is a major public health problem in Australia. Each year around 150,000 Australians are admitted to intensive care (ICU). These critically ill patients require substantial resources and invasive, expensive interventions. Approximately 10% die and many of the remaining patients who survive have delayed and compromised functional recovery. As many as 25% of the ICU survivors who were living at home prior to ICU are unable to return home due to impaired physical function. Globally, the quality of survival following an ICU admission has been identified as one of the largest health challenges for these patients. This study will address the quality of survival and long-term functional recovery for patients who require life support in ICU. These patients account for 62% of the total bed-days in Australian ICUs, with direct care costs of $2 billion per year. The long-term outcomes for these patients are very poor. In my Australian cohort study, 50% of patients who survived hospital had disability
Study Type
OBSERVATIONAL
Enrollment
250
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
John Hunter Hospital
Sydney, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Mater Health
Brisbane, Queensland, Australia
Mater Private Hospital
Brisbane, Queensland, Australia
Caboolture Hospital
Caboolture, Queensland, Australia
Redcliffe Hospital
Redcliffe, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
...and 6 more locations
Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0
level of disability as measured by the World Health Organisation's Disability Schedule 2.0, 2 level (WHODAS) at 2 years after recruitment.
Time frame: Assessed 2 years after recruitment
Time from randomisation until death
Time frame: From date of randomisation until date of death from all cause, censored at 5 years
All-cause mortality
Time frame: From date of randomisation to 1 year
All-cause mortality
Time frame: From date of randomisation to 2 years
All-cause mortality
Time frame: From date of randomisation to 5 years
Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS)
Time frame: Assessed 1 year after recruitment
Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS)
Time frame: Assessed 5 years after recruitment
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Time frame: Assessed 1 year after recruitment
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Time frame: Assessed 2 years after recruitment
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Time frame: Assessed 5 years after recruitment
Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)
Time frame: Assessed 1 year after recruitment
Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)
Time frame: Assessed 2 years after recruitment
Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)
Time frame: Assessed 5 years after recruitment
Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)
Time frame: Assessed 1 year after recruitment
Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)
Time frame: Assessed 2 years after recruitment
Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)
Time frame: Assessed 5 years after recruitment
Psychological function measured using Hospital Anxiety and Depression scale
Time frame: Assessed 1 year after recruitment
Psychological function measured using Hospital Anxiety and Depression scale
Time frame: Assessed 2 years after recruitment
Psychological function measured using Hospital Anxiety and Depression scale
Time frame: Assessed 5 years after recruitment
Psychological function measured using Impact of Event Scale - Revised (IES-R)
Time frame: Assessed 1 year after recruitment
Psychological function measured using Impact of Event Scale - Revised (IES-R)
Time frame: Assessed 2 years after recruitment
Psychological function measured using Impact of Event Scale - Revised (IES-R)
Time frame: Assessed 5 years after recruitment
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