The TEAM Long-Term Cohort Study (A Sub-study of TEAM(III))

Study Overview
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Brief Summary
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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
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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

Official Title
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Long-term Evaluation of Disability and Quality of Life at 1,2 and 5 Years in Invasively Mechanically Ventilated Patients Who Received Early Activity and Mobilisation Compared to Standard Care.

Conditions
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Critically Ill, Mechanical Ventilation, Long Term Outcome

Intervention / Treatment
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* Behavioral: Early activity and Mobilisation Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in the TEAM Phase III RCT Protocol. Exclusion Criteria: There are no exclusion criteria.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intervention arm: TEAM protocol<br>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. | Behavioral: Early activity and Mobilisation Intervention<br>* The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities<br>|
| Standard of Care arm: TEAM protocol<br>Based on TEAM (III) protocol the control group will receive standard care from physiotherapy staff not involved in delivering the intervention. We have previously established that standard care in Australia for a patient receiving prolonged IMV (control group intervention) frequently involves no active exercise out of bed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessed 2 years after recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from randomisation until death |  | From date of randomisation until date of death from all cause, censored at 5 years | 
| All-cause mortality |  | From date of randomisation to 1 year | 
| All-cause mortality |  | From date of randomisation to 2 years | 
| All-cause mortality |  | From date of randomisation to 5 years | 
| Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS) |  | Assessed 1 year after recruitment | 
| Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS) |  | Assessed 5 years after recruitment | 
| Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) |  | Assessed 1 year after recruitment | 
| Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) |  | Assessed 2 years after recruitment | 
| Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) |  | Assessed 5 years after recruitment | 
| Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL) |  | Assessed 1 year after recruitment | 
| Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL) |  | Assessed 2 years after recruitment | 
| Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL) |  | Assessed 5 years after recruitment | 
| Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind) |  | Assessed 1 year after recruitment | 
| Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind) |  | Assessed 2 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 1 year after recruitment | 
| Psychological function measured using Hospital Anxiety and Depression scale |  | Assessed 2 years after recruitment | 
| Psychological function measured using Hospital Anxiety and Depression scale |  | Assessed 5 years after recruitment | 
| Psychological function measured using Impact of Event Scale - Revised (IES-R) |  | Assessed 1 year after recruitment | 
| Psychological function measured using Impact of Event Scale - Revised (IES-R) |  | Assessed 2 years after recruitment | 
| Psychological function measured using Impact of Event Scale - Revised (IES-R) |  | Assessed 5 years after recruitment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early activity and mobilization, rehabilitation, intensive care, health status