跳至主要内容
临床试验/NCT07114458
NCT07114458招募中不适用

Delirium Incidence and Cognitive Trajectories in Isolated Older Patients in the Inpatient Setting

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 404 人开始时间: 2025年8月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
404
试验地点
1
主要终点
Delirium

研究概览

简要总结

The goal of this observational study is to examine if older patients who need to be under isolation precautions due to multidrug resistant bacteria or other reasons have an increased risk of suffering from delirium or cognitive decline compared to older patients without isolation precautions.

To compare this, every person under isolation precautions is compared to other persons of the same age, gender, comorbidities, frailty status and hospital department. Delirium is assessed twice daily with a screening tool named 3D-CAM and cognitive performance is tested by the MOCA-Test six weeks after discharge from hospital and compared to baseline values which are assessed directly after study enrollment.

The study duration for each patient participating is from the time of enrollment during hospitalization until 6 weeks after hospital discharge.

详细描述

Delirium is a common complication in older patients during hospitalization. Its prevention is crucial, as it increases morbidity, mortality, and cognitive impairment. Isolation precautions in hospital may further increase delirium risk due to sensory deprivation and reduced mobility.

This study examines the impact of isolation precautions on delirium and neurocognitive disorders in patients ≥70 years. Delirium screening will occur twice daily, with a six-week post-discharge follow-up.

A prospective cohort study will compare delirium incidence in isolated patients with a matched non-isolated control group (matched for age, gender, Charlson Comorbidity Index, Frailty and hospital department). The 3D Confusion Assessment Method (3D-CAM) will be used for Delirium screening. Follow-up assessments will evaluate cognitive function and quality of life. Data will be collected during hospitalization (Days 1-5) and six weeks post-discharge.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •hospitalized patients
  • •under isolation precautions for at least 24h
  • •70 years and above

排除标准

  • •no informed consent
  • •intensive care treatment
  • •life expectancy 14 days or less

研究组 & 干预措施

Exposition

Patients under isolation precautions in hospital

Control

Matched control, no isolation precautions

结局指标

主要结局

Delirium

时间窗: day 1-5 under isolation precautions

Delirium screened by 3D-Confusion Assessment Method 2 times daily

次要结局

  • Quality-of-Life (QoL)(at enrollment and 6 weeks after discharge from hospital)
  • Cognitive performance(at enrollment and six weeks after discharge from hospital)
  • Functional state(at enrollment and six weeks after discharge from hospital)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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