Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- EuroQol 5-Dimension 5-Level (EQ-5D-5L)
研究概览
简要总结
The primary aim is to study change of critical frailty scale (CFS) and health related quality of life (EQ-5D-5L) in a long-term follow-up of ICU survivors. We aim to identify important ICU related predictors for change in CFS and EQ-5D-5L in long term follow up (1 yr).
Secondary aim is to investigate how CFS pre-admission is related to intrahospital treatment intensity level, severity score and mortality.
详细描述
This is a multi-centre norwegian observational, prospective multicenter Norway coordinated from University hospital North Norway, Tromso.
The study is approved by The Regional Committee for Medical Research Ethics Northern Norway.
The following scores will be assessed by asking the patient and relative during ICU stay: CFS, EQ5DL before current critical illness.
The following demographic and clinical data will be retrieved from the medical records: Comorbidity before critical illness, reasons for ICU admission, daily severity score (SOFA- score), length of mechanical ventilation, dialysis, tracheostomy, Habitat before and after ICU treatment, ICU and hospital length of stay, complications retrieved during intensive care treatment, mortality, limitation of treatment.
The patients will be followed up with telephone interview after hospital discharge for evaluation of: Comorbidity, CFS, EQ5DData for all sites are collected and managed using RedCap electronic data capture tools.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 65 years
- •≥ 24 hours mechanical ventilation
- •Written informed consent from patient or next of kin
排除标准
- •Readmission of patient included in the study
- •Not possible to obtain a valid CFS or and EQ-5D-5L at admission or follow-up of CFS because of social context or language.
结局指标
主要结局
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
时间窗: Change in EQ-5D-5L from 3 months to 12 months
The scale measures quality of life on a 5-component scale
Mortality
时间窗: ICU-stay or subsequent 12 months.
Mortality during ICU-stay or subsequent 12 months.
Change in Clinical frailty score
时间窗: Change in Clinical Frailty score from 3 months to 12 months follow up
Score from 1 to 9.
次要结局
- ICU readmission(Long-term follow up (1 yr))
- ICU-LOS(Through total ICU stay, up to 3 months)
- Treatment intensity level(From inclusion in the study to discharge from intensive care unit, up to three months.)