Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 147
- 试验地点
- 1
- 主要终点
- Mean change in Level of Function (LOF) scale score during CICU admission and 1 and 12 months post-hospitalization
研究概览
简要总结
An early mobilization (EM) program will be implemented in the Cardiovascular Intensive Care Unit at the Jewish General Hospital (JGH), an academic tertiary hospital in Montreal, Quebec.
The investigators will perform a prospective, pre/post-EM intervention study in adults aged ≥60 years old admitted to the Cardiovascular Intensive Care Unit (CICU) at the JGH. During a 3-month period, the investigators will prospectively enrol patients to the pre-intervention cohort. The EM intervention will then be implemented. During a 12-month period, the investigators will prospectively enrol patients to the intervention cohort. 1 and 12 months following hospital discharge, patients in the pre-intervention and post-intervention cohorts will be contacted by phone by a member of the research team to assess for functional status and quality of life measures.
The primary effectiveness outcome will be the mean improvement in level of function (LOF) during CICU admission and at 1 and 12 months. Covariates predicting improvement in LOF ("responsiveness") and ones which do not ("non-responsiveness") will be assessed. The recovery of physical function at 1 month and 6 months as measured by the SF-36 physical component summary score will be assessed. The SF-36 scores of the highest scoring tertile of LOF on hospital discharge will be compared with the lowest scoring tertile. Hospital readmission at 30 days and discharge home vs. healthcare facility will also be compared. For safety, the composite and individual components of the number of falls, injuries, and dislodgements over the total number of attempted mobility activities will be recorded. The results from the intervention cohort will be compared to the pre-intervention cohort for all results.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participating in early mobilization program
- •Age 60 years old or older
排除标准
- •CICU stays less than 24 hours
- •Patients with prehospital LOF 0 (immobile), LOF 1 (bedbound) or 2 (can sit in chair only).
- •Cardiac surgery patients will also be excluded.
结局指标
主要结局
Mean change in Level of Function (LOF) scale score during CICU admission and 1 and 12 months post-hospitalization
时间窗: Duration of Cardiac Intensive Care Unit stay (average 4 days) and 1 and 12 months post-hosptialization
The mean improvement change in the Level of Function scale score in patients undergoing early mobilization. The Level of Function scale measures mobility and ranges from 0 (bed immobile) to 5 (walking more than 20 meters), with higher scores indicating better mobility.
次要结局
- Recovery of physical function(1 month and 12 months.)
- Recovery of functional ability(1 month and 12 months)
研究者
Michael Goldfarb
Attending Staff, Division of Cardiology
Lady Davis Institute