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

NCT ID: NCT05298982

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-11

Study Completion Date

2026-11-30

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

Conditions

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Critically Ill Mechanical Ventilation Long Term Outcome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention arm: TEAM protocol

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.

Early activity and Mobilisation Intervention

Intervention Type BEHAVIORAL

The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities

Standard of Care arm: TEAM protocol

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.

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Enrolled in the TEAM Phase III RCT Protocol.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Institute of New Zealand

OTHER

Sponsor Role collaborator

National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

ANZICS Clinical Trials Group

NETWORK

Sponsor Role collaborator

Australian and New Zealand Intensive Care Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof Carol Hodgson

Role: STUDY_CHAIR

ANZIC-RC

Locations

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Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Site Status

John Hunter Hospital

Sydney, New South Wales, Australia

Site Status

Royal North Shore Hospital

Sydney, New South Wales, Australia

Site Status

Wollongong Hospital

Wollongong, New South Wales, Australia

Site Status

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Site Status

Mater Health

Brisbane, Queensland, Australia

Site Status

Mater Private Hospital

Brisbane, Queensland, Australia

Site Status

Caboolture Hospital

Caboolture, Queensland, Australia

Site Status

Redcliffe Hospital

Redcliffe, Queensland, Australia

Site Status

Toowoomba Hospital

Toowoomba, Queensland, Australia

Site Status

Launceston General Hospital

Launceston, Tasmania, Australia

Site Status

Geelong Hospital - Barwon Health

Geelong, Victoria, Australia

Site Status

Cabrini Hospital

Malvern, Victoria, Australia

Site Status

Royal Melbourne Hospital

Parkville, Victoria, Australia

Site Status

Alfred Hospital

Prahran, Victoria, Australia

Site Status

Sunshine Hospital

St Albans, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type BACKGROUND
PMID: 24638143 (View on PubMed)

Herridge MS, Tansey CM, Matte 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.

Reference Type BACKGROUND
PMID: 21470008 (View on PubMed)

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(1):81. doi: 10.1186/s13054-015-0765-4.

Reference Type BACKGROUND
PMID: 25715872 (View on PubMed)

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. No abstract available.

Reference Type BACKGROUND
PMID: 20679565 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22875378 (View on PubMed)

Higgins AM, Pettila 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. doi: 10.1177/0310057X1103900308.

Reference Type BACKGROUND
PMID: 21675057 (View on PubMed)

Related Links

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Other Identifiers

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U1111-1195-3567-A9

Identifier Type: -

Identifier Source: org_study_id

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