NCT05298982

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

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.

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Australian and New Zealand Intensive Care Research Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

• Critically Ill
• Mechanical Ventilation
• Long Term Outcome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2020-02-11
• Primary completion: 2023-11-01
• Completion: 2026-11-01
• First posted: 2022-03-28
• Last updated: 2022-03-28

Locations

16 sites across 1 country: Australia