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.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 250
- 试验地点
- 16
- 主要终点
- Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in the TEAM Phase III RCT Protocol.
排除标准
- •There are no exclusion criteria.
结局指标
主要结局
Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0
时间窗: 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.
次要结局
- All-cause mortality(From date of randomisation to 5 years)
- Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS)(Assessed 5 years after recruitment)
- Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)(Assessed 5 years after recruitment)
- Psychological function measured using Hospital Anxiety and Depression scale(Assessed 5 years after recruitment)
- Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)(Assessed 5 years after recruitment)
- Time from randomisation until death(From date of randomisation until date of death from all cause, censored at 5 years)
- Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)(Assessed 5 years after recruitment)
- Psychological function measured using Impact of Event Scale - Revised (IES-R)(Assessed 5 years after recruitment)