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临床试验/NCT05266118
NCT05266118已完成不适用

Patient Reported Symptoms the First Week After Intensive Care Unit Discharge and up to Hospital Discharge

Ostfold Hospital Trust2 个研究点 分布在 1 个国家目标入组 177 人开始时间: 2022年4月19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
177
试验地点
2
主要终点
Multiple symptoms

研究概览

简要总结

The overall objective of this study is a) to increase knowledge about ICU patient's symptoms and symptom clusters during the first week after ICU discharge, and b) to identify cognitive, psychological, and physical symptoms and health state at hospital discharge.

详细描述

Several studies have examined how ICU patients experience being in the ICU, and up to 75% of ICU patients experience multiple intensive care related symptoms while in the ICU. Other studies have examined ICU patients' transfer from ICU to hospital wards, and the transfer may cause mixed emotions for the patient, both positive perception of an improvement in the patient's condition, but also negative perception of decreased monitoring of the patient and less staff involvement in their care. Further, extensive literature exists examining the long-term effects of being an ICU patient, and a major proportion of ICU survivors develop a combination of cognitive, psychological, and physical symptoms, which can persist for months or even years after hospital discharge. This phenomena is now recognized as post intensive care syndrome (PICS). These consequences are associated with a combination of reduced quality of life, impaired functional status and impaired daily functioning, and has consequences for both ICU survivors and their families. However, studies about what ICU patients' experience just after ICU discharge (in hospital wards), is scarce. In this time, patients are still in need of advanced personalized care after having survived critical illness and intensive care treatment.

This study will increase knowledge about symptoms and symptom clusters in ICU patients during the first week after ICU discharge, and at hospital discharge. In these areas, evidence is lacking. This knowledge will help health care providers to optimize and improve patient care and recovery during the first time period after critically illness, by providing more tailored symptom management at the right time in future support strategies and future plans for rehabilitation.

The present study is a single-center study and has a prospective, longitudinal design. A set of different symptoms are measured in 170 former ICU patients the first week after ICU discharge, in addition to a set of cognitive, psychological, and physical symptoms and health state at hospital discharge. We will measure:

  1. Totally 32 different symptoms on day 1; day 3; day 5; and day 7 after ICU discharge
  2. A set of cognitive (assessing the level of cognitive function), psychological (posttraumatic stress, anxiety, depression), and physical symptoms (activities of daily life) and health status at hospital discharge. The same set of questionnaires will be filled in during ward stay reflecting patient situation one week prior to ICU admittance (used as baseline measures).

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Multiple symptoms

时间窗: Up to 1 week after ICU discharge

Multiple symptoms is measured with the Memorial Symptoms Assessment Scale (MSAS).The patients will be asked to indicate whether they experience 32 different symptoms (i.e., occurence). Those who experience a symptom will be asked to rate its frequency (from rarely \[1 point\] to almost constantly \[4 points\]); intensity (from slight \[1 p\] to very severe \[4 p\]); and distress or bother (from not at all \[0 p\] to very much \[4 p\]). Here, higher score indicate worse symptom experience.

次要结局

  • Cognitive symptoms(At hospital discharge, an average of one week)
  • Posttraumatic stress symptoms(At hospital discharge, an average of one week)
  • Health-related quality of life state(At hospital discharge, an average of one week)
  • Physical symptoms(At hospital discharge, an average of one week)
  • Anxiety and depression(At hospital discharge, an average of one week)
  • Health status(At hospital discharge, an average of one week)

研究者

发起方
Ostfold Hospital Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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