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Critically IllNCT05298982

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

An observational study of Critically Ill and Mechanical Ventilation, run by Australian and New Zealand Intensive Care Research Centre at 16 sites in Australia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Early activity and Mobilisation Intervention
How many people
250 participants
Where
16 sitesAustralia
Study dates
11 Feb 2020to Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Up to 380 critically ill adult Australian patients, who met all of the inclusion criteria and none of the exclusion criteria, as defined in the TEAM Phase III RCT and consent to follow-up.

Who may be able to join

  • Enrolled in the TEAM Phase III RCT Protocol.

Who cannot join

  • There are no exclusion criteria.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

16 sites in 1 country

Australia16 sites

  • Sunshine Coast University Hospital

    Birtinya, Queensland

  • Mater Health

    Brisbane, Queensland

  • Mater Private Hospital

    Brisbane, Queensland

  • Caboolture Hospital

    Caboolture, Queensland

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Geelong Hospital - Barwon Health

    Geelong, Victoria, 3220

  • Launceston General Hospital

    Launceston, Tasmania

  • Cabrini Hospital

    Malvern, Victoria, 3144

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Alfred Hospital

    Prahran, Victoria, 3004

  • Redcliffe Hospital

    Redcliffe, Queensland, 4020

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • John Hunter Hospital

    Sydney, New South Wales

  • Royal North Shore Hospital

    Sydney, New South Wales

  • Toowoomba Hospital

    Toowoomba, Queensland

  • Wollongong Hospital

    Wollongong, New South Wales

Other trials in Australia

About this study

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.

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.

Read the 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

Being tested
Early activity and Mobilisation Intervention
Keywords
Early activity and mobilization, rehabilitation, intensive care, health status
Medical subject headings
Critical Illness, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Early activity and Mobilisation InterventionBehavioural

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

Study groups in NCT05298982
Study groupRoleWhat they receive
Intervention arm: TEAM protocolBased 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.
Receives: Behavioral: Early activity and Mobilisation Intervention
Standard of Care arm: TEAM protocolBased 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Assessed 2 years after recruitment

Secondary outcomes (21)

  1. Time from randomisation until death

    Measured: From date of randomisation until date of death from all cause, censored at 5 years

  2. All-cause mortality

    Measured: From date of randomisation to 1 year

  3. All-cause mortality

    Measured: From date of randomisation to 2 years

  4. All-cause mortality

    Measured: From date of randomisation to 5 years

  5. Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS)

    Measured: Assessed 1 year after recruitment

  6. Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS)

    Measured: Assessed 5 years after recruitment

  7. Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)

    Measured: Assessed 1 year after recruitment

  8. Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)

    Measured: Assessed 2 years after recruitment

  9. Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)

    Measured: Assessed 5 years after recruitment

  10. Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)

    Measured: Assessed 1 year after recruitment

  11. Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)

    Measured: Assessed 2 years after recruitment

  12. Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)

    Measured: Assessed 5 years after recruitment

  13. Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)

    Measured: Assessed 1 year after recruitment

  14. Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)

    Measured: Assessed 2 years after recruitment

  15. Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)

    Measured: Assessed 5 years after recruitment

  16. Psychological function measured using Hospital Anxiety and Depression scale

    Measured: Assessed 1 year after recruitment

  17. Psychological function measured using Hospital Anxiety and Depression scale

    Measured: Assessed 2 years after recruitment

  18. Psychological function measured using Hospital Anxiety and Depression scale

    Measured: Assessed 5 years after recruitment

  19. Psychological function measured using Impact of Event Scale - Revised (IES-R)

    Measured: Assessed 1 year after recruitment

  20. Psychological function measured using Impact of Event Scale - Revised (IES-R)

    Measured: Assessed 2 years after recruitment

  21. Psychological function measured using Impact of Event Scale - Revised (IES-R)

    Measured: Assessed 5 years after recruitment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start11 Feb 2020
  3. Primary completionNov 2023 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05298982
Sponsor's protocol ID
U1111-1195-3567-A9
Status last verified
Mar 2022
First submitted
18 Mar 2022
Last updated
28 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24638143

  • 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.

    PubMed 21470008

  • 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.

    PubMed 25715872

  • 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.

    PubMed 20679565

  • 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.

    PubMed 22875378

  • 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.

    PubMed 21675057

Questions about this trial

What is this clinical trial studying?

An observational study of Critically Ill and Mechanical Ventilation, run by Australian and New Zealand Intensive Care Research Centre at 16 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0 (time frame: Assessed 2 years after recruitment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05298982, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.

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