Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05298982




Registration number
NCT05298982
Ethics application status
Date submitted
18/03/2022
Date registered
28/03/2022
Date last updated
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] 0 0
U1111-1195-3567-A9
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically Ill 0 0
Mechanical Ventilation 0 0
Long Term Outcome 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Behaviour - 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.


Behaviour: 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] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0
Timepoint [1] 0 0
Assessed 2 years after recruitment
Secondary outcome [1] 0 0
Time from randomisation until death
Timepoint [1] 0 0
From date of randomisation until date of death from all cause, censored at 5 years
Secondary outcome [2] 0 0
All-cause mortality
Timepoint [2] 0 0
From date of randomisation to 1 year
Secondary outcome [3] 0 0
All-cause mortality
Timepoint [3] 0 0
From date of randomisation to 2 years
Secondary outcome [4] 0 0
All-cause mortality
Timepoint [4] 0 0
From date of randomisation to 5 years
Secondary outcome [5] 0 0
Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS)
Timepoint [5] 0 0
Assessed 1 year after recruitment
Secondary outcome [6] 0 0
Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS)
Timepoint [6] 0 0
Assessed 5 years after recruitment
Secondary outcome [7] 0 0
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Timepoint [7] 0 0
Assessed 1 year after recruitment
Secondary outcome [8] 0 0
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Timepoint [8] 0 0
Assessed 2 years after recruitment
Secondary outcome [9] 0 0
Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
Timepoint [9] 0 0
Assessed 5 years after recruitment
Secondary outcome [10] 0 0
Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)
Timepoint [10] 0 0
Assessed 1 year after recruitment
Secondary outcome [11] 0 0
Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)
Timepoint [11] 0 0
Assessed 2 years after recruitment
Secondary outcome [12] 0 0
Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)
Timepoint [12] 0 0
Assessed 5 years after recruitment
Secondary outcome [13] 0 0
Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)
Timepoint [13] 0 0
Assessed 1 year after recruitment
Secondary outcome [14] 0 0
Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)
Timepoint [14] 0 0
Assessed 2 years after recruitment
Secondary outcome [15] 0 0
Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)
Timepoint [15] 0 0
Assessed 5 years after recruitment
Secondary outcome [16] 0 0
Psychological function measured using Hospital Anxiety and Depression scale
Timepoint [16] 0 0
Assessed 1 year after recruitment
Secondary outcome [17] 0 0
Psychological function measured using Hospital Anxiety and Depression scale
Timepoint [17] 0 0
Assessed 2 years after recruitment
Secondary outcome [18] 0 0
Psychological function measured using Hospital Anxiety and Depression scale
Timepoint [18] 0 0
Assessed 5 years after recruitment
Secondary outcome [19] 0 0
Psychological function measured using Impact of Event Scale - Revised (IES-R)
Timepoint [19] 0 0
Assessed 1 year after recruitment
Secondary outcome [20] 0 0
Psychological function measured using Impact of Event Scale - Revised (IES-R)
Timepoint [20] 0 0
Assessed 2 years after recruitment
Secondary outcome [21] 0 0
Psychological function measured using Impact of Event Scale - Revised (IES-R)
Timepoint [21] 0 0
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?
No
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] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
John Hunter Hospital - Sydney
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [6] 0 0
Mater Health - Brisbane
Recruitment hospital [7] 0 0
Mater Private Hospital - Brisbane
Recruitment hospital [8] 0 0
Caboolture Hospital - Caboolture
Recruitment hospital [9] 0 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [10] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [11] 0 0
Launceston General Hospital - Launceston
Recruitment hospital [12] 0 0
Geelong Hospital - Barwon Health - Geelong
Recruitment hospital [13] 0 0
Cabrini Hospital - Malvern
Recruitment hospital [14] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [15] 0 0
Alfred Hospital - Prahran
Recruitment hospital [16] 0 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Wollongong
Recruitment postcode(s) [4] 0 0
- Birtinya
Recruitment postcode(s) [5] 0 0
- Brisbane
Recruitment postcode(s) [6] 0 0
- Caboolture
Recruitment postcode(s) [7] 0 0
4020 - Redcliffe
Recruitment postcode(s) [8] 0 0
- Toowoomba
Recruitment postcode(s) [9] 0 0
- Launceston
Recruitment postcode(s) [10] 0 0
3220 - Geelong
Recruitment postcode(s) [11] 0 0
3144 - Malvern
Recruitment postcode(s) [12] 0 0
3050 - Parkville
Recruitment postcode(s) [13] 0 0
3004 - Prahran
Recruitment postcode(s) [14] 0 0
3021 - St Albans

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Intensive Care Research Centre
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medical Research Institute of New Zealand
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Health and Medical Research Council, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
ANZICS Clinical Trials Group
Address [3] 0 0
Country [3] 0 0

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/ct2/show/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 0 0
Prof Carol Hodgson
Address 0 0
ANZIC-RC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05298982