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Enrolling by Invitation

NCT Number: NCT05298982

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

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.

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Key information

Conditions

Critically Ill Behavior Critical Illness Disease Attributes Long Term Outcome Mechanical Ventilation Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled in the TEAM Phase III RCT Protocol.

Exclusion criteria

  • There are no exclusion criteria.

Treatment and study plan

Early activity and Mobilisation intervention

Behavioral

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

Primary outcomes

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

    Time frame: Assessed 2 years after recruitment

    level of disability as measured by the World Health Organisation's Disability Schedule 2.0, 2 level (WHODAS) at 2 years after recruitment.

Secondary outcomes

  1. Time from randomisation until death

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

  2. All-cause mortality

    Time frame: From date of randomisation to 1 year

  3. All-cause mortality

    Time frame: From date of randomisation to 2 years

  4. All-cause mortality

    Time frame: From date of randomisation to 5 years

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

    Time frame: Assessed 1 year after recruitment

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Assessed 5 years after recruitment

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

    Time frame: Assessed 1 year after recruitment

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

    Time frame: Assessed 2 years after recruitment

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

    Time frame: Assessed 5 years after recruitment

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

    Time frame: Assessed 1 year after recruitment

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

    Time frame: Assessed 2 years after recruitment

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

    Time frame: Assessed 5 years after recruitment

  16. Psychological function measured using Hospital Anxiety and Depression scale

    Time frame: Assessed 1 year after recruitment

  17. Psychological function measured using Hospital Anxiety and Depression scale

    Time frame: Assessed 2 years after recruitment

  18. Psychological function measured using Hospital Anxiety and Depression scale

    Time frame: Assessed 5 years after recruitment

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

    Time frame: Assessed 1 year after recruitment

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

    Time frame: Assessed 2 years after recruitment

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

    Time frame: Assessed 5 years after recruitment

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Collaborators

  • ANZICS Clinical Trials Group
  • Medical Research Institute of New Zealand
  • National Health and Medical Research Council, Australia

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2023
Study completion
2026
First posted
Mar 28, 2022
Registry last updated
Mar 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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