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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05298982

Registration number

NCT05298982

Ethics application status

Date submitted

18/03/2022

Date registered

28/03/2022

Titles & IDs

Public title

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

Scientific 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.

Secondary ID [1]

U1111-1195-3567-A9

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Critically Ill

Mechanical Ventilation

Long Term Outcome

Condition category

Condition code

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

BEHAVIORAL - Early activity and Mobilisation Intervention

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.

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.

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

Intervention code [1]

BEHAVIORAL

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0

Timepoint [1]

Assessed 2 years after recruitment

Secondary outcome [1]

Time from randomisation until death

Timepoint [1]

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

Secondary outcome [2]

All-cause mortality

Timepoint [2]

From date of randomisation to 1 year

Secondary outcome [3]

All-cause mortality

Timepoint [3]

From date of randomisation to 2 years

Secondary outcome [4]

All-cause mortality

Timepoint [4]

From date of randomisation to 5 years

Secondary outcome [5]

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

Timepoint [5]

Assessed 1 year after recruitment

Secondary outcome [6]

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

Timepoint [6]

Assessed 5 years after recruitment

Secondary outcome [7]

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

Timepoint [7]

Assessed 1 year after recruitment

Secondary outcome [8]

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

Timepoint [8]

Assessed 2 years after recruitment

Secondary outcome [9]

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

Timepoint [9]

Assessed 5 years after recruitment

Secondary outcome [10]

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

Timepoint [10]

Assessed 1 year after recruitment

Secondary outcome [11]

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

Timepoint [11]

Assessed 2 years after recruitment

Secondary outcome [12]

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

Timepoint [12]

Assessed 5 years after recruitment

Secondary outcome [13]

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

Timepoint [13]

Assessed 1 year after recruitment

Secondary outcome [14]

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

Timepoint [14]

Assessed 2 years after recruitment

Secondary outcome [15]

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

Timepoint [15]

Assessed 5 years after recruitment

Secondary outcome [16]

Psychological function measured using Hospital Anxiety and Depression scale

Timepoint [16]

Assessed 1 year after recruitment

Secondary outcome [17]

Psychological function measured using Hospital Anxiety and Depression scale

Timepoint [17]

Assessed 2 years after recruitment

Secondary outcome [18]

Psychological function measured using Hospital Anxiety and Depression scale

Timepoint [18]

Assessed 5 years after recruitment

Secondary outcome [19]

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

Timepoint [19]

Assessed 1 year after recruitment

Secondary outcome [20]

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

Timepoint [20]

Assessed 2 years after recruitment

Secondary outcome [21]

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

Timepoint [21]

Assessed 5 years after recruitment

Eligibility

Key inclusion criteria

* Enrolled in the TEAM Phase III RCT Protocol.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

* There are no exclusion criteria.

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

11/02/2020

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

1/11/2026

Actual

Sample size

Target

250

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,TAS,VIC

Recruitment hospital [1]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [2]

John Hunter Hospital - Sydney

Recruitment hospital [3]

Royal North Shore Hospital - Sydney

Recruitment hospital [4]

Wollongong Hospital - Wollongong

Recruitment hospital [5]

Sunshine Coast University Hospital - Birtinya

Recruitment hospital [6]

Mater Health - Brisbane

Recruitment hospital [7]

Mater Private Hospital - Brisbane

Recruitment hospital [8]

Caboolture Hospital - Caboolture

Recruitment hospital [9]

Redcliffe Hospital - Redcliffe

Recruitment hospital [10]

Toowoomba Hospital - Toowoomba

Recruitment hospital [11]

Launceston General Hospital - Launceston

Recruitment hospital [12]

Geelong Hospital - Barwon Health - Geelong

Recruitment hospital [13]

Cabrini Hospital - Malvern

Recruitment hospital [14]

Royal Melbourne Hospital - Parkville

Recruitment hospital [15]

Alfred Hospital - Prahran

Recruitment hospital [16]

Sunshine Hospital - St Albans

Recruitment postcode(s) [1]

2050 - Camperdown

Recruitment postcode(s) [2]

- Sydney

Recruitment postcode(s) [3]

- Wollongong

Recruitment postcode(s) [4]

- Birtinya

Recruitment postcode(s) [5]

- Brisbane

Recruitment postcode(s) [6]

- Caboolture

Recruitment postcode(s) [7]

4020 - Redcliffe

Recruitment postcode(s) [8]

- Toowoomba

Recruitment postcode(s) [9]

- Launceston

Recruitment postcode(s) [10]

3220 - Geelong

Recruitment postcode(s) [11]

3144 - Malvern

Recruitment postcode(s) [12]

3050 - Parkville

Recruitment postcode(s) [13]

3004 - Prahran

Recruitment postcode(s) [14]

3021 - St Albans

Funding & Sponsors

Primary sponsor type

Other

Name

Australian and New Zealand Intensive Care Research Centre

Address

Country

Other collaborator category [1]

Other

Name [1]

Medical Research Institute of New Zealand

Address [1]

Country [1]

Other collaborator category [2]

Other

Name [2]

National Health and Medical Research Council, Australia

Address [2]

Country [2]

Other collaborator category [3]

Other

Name [3]

ANZICS Clinical Trials Group

Address [3]

Country [3]

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT05298982

Trial related presentations / 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.
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.
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.
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.
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.
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.

Public notes

Contacts

Principal investigator

Name

Prof Carol Hodgson

Address

ANZIC-RC

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05298982

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05298982