Treatment of Invasively Ventilated Adults With Early Activity and Mobilisation (TEAM(III))
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03133377|
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : August 24, 2018
The aim of this study is to evaluate the effect of early activity and mobilisation during prolonged IMV on the composite outcome "days alive and out of hospital to day 180". The effect of the intervention on mortality, physical, cognitive and Psychological function at 180 days, as well as cost-effectiveness of the intervention, will also be evaluated. The study will also explore process of care measures and baseline physiology and ICU mobility outcomes.
The hypothesis is that, in ICU patients expected to require prolonged IMV, early activity and mobilisation increases the number of days alive and at home to day 180 when compared with standard care.
|Condition or disease||Intervention/treatment||Phase|
|Critically Ill, Mechanically Ventilated||Behavioral: Early activity and mobilisation||Phase 3|
The TEAM Trial is a definitive phase III multi-centre randomised controlled trial in mechanically ventilated patients. Supported by compelling preliminary data, the trial will determine whether early activity and mobilisation during mechanical ventilation improves days alive and at home at 6 months compared to standard care. Recruiting 750 patients, this will be the largest trial ever conducted of early mobilisation.
Patients allocated to the early activity and mobilisation protocol (intervention group) will be assessed by a physiotherapist daily during the ICU stay to determine the highest level of mobility. This will determine the dosage and type of exercise that will be delivered, led by the physiotherapist with assistance from the multidisciplinary team. For both groups, concomitant care will be guided by the treating clinician. In addition, all post-ICU patient management will be at the discretion of the patient's ward-based treating physicians.
Patients will be randomized via web-based system and de-identified data will be collected on the following: baseline demographics; comorbidities; sedatives, analgesics, corticosteroids and neuromuscular blockers; pain/sedation/delirium scores; tracheostomy, intubation and renal replacement therapy. The intervention will be administered during the ICU stay and the 180 day follow up will be conducted centrally.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||750 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Prospective Multicentre Phase III Randomised Controlled Trial of Early Activity and Mobilisation Compared With Standard Care in Invasively Ventilated Patients in Intensive Care|
|Actual Study Start Date :||November 14, 2017|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Early activity and Mobilisation intervention
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.
Behavioral: Early activity and mobilisation
The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities
No Intervention: Standard of care
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.
- Number of days alive and out of hospital [ Time Frame: between randomisation and 180 days ]Any days spent in rehabilitation or a nursing home counted as days in hospital
- All-cause mortality [ Time Frame: From date of randomisation up to180days. ]
- Time from randomisation until death [ Time Frame: From date of randomisation unitl date of death from all cause, censored at 180days ]
- Ventilator-free days [ Time Frame: From date of randomisation until day 28 ]patients who die prior to day 28 will be assigned zero ventilator-free days
- ICU-free days [ Time Frame: From date of randomisation until day 28 ]patients who die prior to day 28 will be assigned zero ICU-free days
- Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) [ Time Frame: Assessed at 180days ]
- Independent activities of daily living measured with Barthel Activities of Daily Living (ADL) Index and The Lawton Instrumental Activities of Daily Living Scale (IADL) [ Time Frame: Assessed at 180days ]
- Generic function and disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) [ Time Frame: Assessed at 180days ]
- Delirium free days [ Time Frame: From date of randomisation until day 28 ]Will be measured using CAM-ICU and RASS score
- Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind) [ Time Frame: Assessed at 180days ]
- Psychological function measured using Hospital Anxiety and Depression scale (HADS) [ Time Frame: Assessed at 180days ]
- Psychological function measured using Impact of Event Scale - Revised (IES-R) [ Time Frame: Assessed at 180days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133377
|Contact: Janani Sivasuthan||+61 3 9903 0932||Janani.Sivasuthan@monash.edu|
|Contact: Lynne Murray||+61 419 155 983||Lynnette.Murray@monash.edu|
|Study Chair:||Carol Hodgson||ANZIC-RC|