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

Mechanical Ventilation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05298982
• Other study ID #: U1111-1195-3567-A9
• Status: Enrolling by invitation
• Start date: February 11, 2020
• Est. completion date: November 2026

Study information

• Verified date: March 2022
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 250
• Est. completion date: November 2026
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrolled in the TEAM Phase III RCT Protocol.

Exclusion Criteria:

• There are no exclusion criteria.

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill
• Long Term Outcome
• Mechanical Ventilation

Intervention

Behavioral:
• Early activity and Mobilisation Intervention
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities

Locations

Country	Name	City	State
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Mater Health	Brisbane	Queensland
Australia	Mater Private Hospital	Brisbane	Queensland
Australia	Caboolture Hospital	Caboolture	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Geelong Hospital - Barwon Health	Geelong	Victoria
Australia	Launceston General Hospital	Launceston	Tasmania
Australia	Cabrini Hospital	Malvern	Victoria
Australia	Royal Melbourne Hospital	Parkville	Victoria
Australia	Alfred Hospital	Prahran	Victoria
Australia	Redcliffe Hospital	Redcliffe	Queensland
Australia	Sunshine Hospital	St Albans	Victoria
Australia	John Hunter Hospital	Sydney	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	Toowoomba Hospital	Toowoomba	Queensland
Australia	Wollongong Hospital	Wollongong	New South Wales

Sponsors (4)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	ANZICS Clinical Trials Group, Medical Research Institute of New Zealand, National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (6)

Herridge MS, Tansey CM, Matté A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802. — View Citation

Higgins AM, Pettilä V, Harris AH, Bailey M, Lipman J, Seppelt IM, Webb SA. The critical care costs of the influenza A/H1N1 2009 pandemic in Australia and New Zealand. Anaesth Intensive Care. 2011 May;39(3):384-91. — View Citation

Iwashyna TJ, Netzer G. The burdens of survivorship: an approach to thinking about long-term outcomes after critical illness. Semin Respir Crit Care Med. 2012 Aug;33(4):327-38. doi: 10.1055/s-0032-1321982. Epub 2012 Aug 8. — View Citation

Iwashyna TJ. Survivorship will be the defining challenge of critical care in the 21st century. Ann Intern Med. 2010 Aug 3;153(3):204-5. doi: 10.7326/0003-4819-153-3-201008030-00013. — View Citation

Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637. — View Citation

TEAM Study Investigators, Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19:81. doi: 10.1186/s13054-015-0765-4. — View Citation

Outcome

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

External Links

•   TEAM study website