The TEAM Long-Term Cohort Study (A Sub-study of TEAM(III))
- Conditions
- Critically IllLong Term OutcomeMechanical Ventilation
- Interventions
- Behavioral: Early activity and Mobilisation Intervention
- Registration Number
- NCT05298982
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 250
- Enrolled in the TEAM Phase III RCT Protocol.
- There are no exclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intervention arm: TEAM protocol Early activity and Mobilisation Intervention Based on TEAM (III) protocol patients will be assessed daily by an ICU physiotherapist using the ICU Mobility Scale (IMS) to determine the dosage and type of active exercises the patient will receive, using the early activity and mobilisation protocol. This protocol is hierarchical, with the objective of each intervention session beginning with the highest level of activity possible for the longest time possible, which then steps down to lower levels of activity if the patient fatigues. The intervention will be administered on all days in which the patient is admitted to ICU during the index hospitalisation, censored at 28days after.
- Primary Outcome Measures
Name Time Method Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0 Assessed 2 years after recruitment level of disability as measured by the World Health Organisation's Disability Schedule 2.0, 2 level (WHODAS) at 2 years after recruitment.
- Secondary Outcome Measures
Name Time Method Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS) Assessed 5 years after recruitment Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind) Assessed 5 years after recruitment Psychological function measured using Hospital Anxiety and Depression scale Assessed 5 years after recruitment Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL) Assessed 5 years after recruitment Time from randomisation until death From date of randomisation until date of death from all cause, censored at 5 years Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) Assessed 5 years after recruitment Psychological function measured using Impact of Event Scale - Revised (IES-R) Assessed 5 years after recruitment All-cause mortality From date of randomisation to 5 years
Trial Locations
- Locations (16)
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
Mater Health
🇦🇺Brisbane, Queensland, Australia
Sunshine Coast University Hospital
🇦🇺Birtinya, Queensland, Australia
Mater Private Hospital
🇦🇺Brisbane, Queensland, Australia
Caboolture Hospital
🇦🇺Caboolture, Queensland, Australia
Redcliffe Hospital
🇦🇺Redcliffe, Queensland, Australia
Toowoomba Hospital
🇦🇺Toowoomba, Queensland, Australia
Launceston General Hospital
🇦🇺Launceston, Tasmania, Australia
Sunshine Hospital
🇦🇺St Albans, Victoria, Australia
Alfred Hospital
🇦🇺Prahran, Victoria, Australia
Cabrini Hospital
🇦🇺Malvern, Victoria, Australia
Geelong Hospital - Barwon Health
🇦🇺Geelong, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia