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临床试验/NCT03714230
NCT03714230已完成不适用

The Trajectory of Functional Status During the First Year After ICU Admission.

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 603 人开始时间: 2018年10月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
603
试验地点
1
主要终点
A cohort study on change of Functional Status during the first year after an ICU admission

研究概览

简要总结

Longitudinal prospective observational multicenter study in a mixed population of intensive care unit (ICU) patients (n=650). The overall purpose of this research proposal is to increase the knowledge in how pre-morbid condition, symptoms during treatment, and selected clinical variables affect self-reported functional status during first year after an ICU admission.

详细描述

For this study data will be collected using self-report questionnaires for the long-term outcome (e.g functional status) and several covariates (e.g., cognition, anxiety and depression, PTSD, QOL, general symptoms, frailty). To retrieve baseline data from prior ICU admission, family members will be used as proxy reporters at inclusion. During treatment in the ICU, patients will be mapped for 5 pre-selected symptoms every day for 7 days, or until death or ICU discharge. Several clinical variables (e.g., SOFA score, pain score, level of sedation, mobilization, medication, mouth care) will be collected daily until maximum 7 days. Follow-up data will be collected at 3, 6 and 12 months after ICU admission using self-report questionnaires.

The predictive value of pre-morbid condition prior to ICU admission on functional status during the first year after an ICU admission will be investigated, when controlled for various clinical and demographic variables. As a secondary analyses, the present study will identify both the occurrence of symptoms as well as the severity and distress of each symptom, while in the ICU. Another secondary outcome that will be measured in this longitudinal study is the association between cognitive function one year after an ICU admission and various mental health variables (PTSD, anxiety and depression).

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

入选标准

  • 未提供

排除标准

  • Re-admissions to the ICU (within 72 hours from last ICU discharge)
  • Pre-defined cognitive deficit (e.g. dementia)
  • Unable to read and Write Norwegian
  • Not included in the study within the first 48 hours since admission to the ICU

结局指标

主要结局

A cohort study on change of Functional Status during the first year after an ICU admission

时间窗: September 2018- May 2020

Data on functional status will be collected using PROMS (e.g Katz index and Lawton IADL) at baseline, and then after 3, 6 and 12 months.

次要结局

  • The investigation of 5 pre-selected symptoms during the ICU stay(September 2018 - December 2020)
  • Posttraumatic Stress Symptoms one year after ICU admission in a mixed ICU population, and the importance of hope(January 2020 - December 2021)
  • Cognitive functioning one year after ICU admission in a mixed ICU population(September 2018 - December 2020)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tone Rustøen

Professor

Oslo University Hospital

研究点 (1)

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