跳至主要内容
临床试验/NCT06498297
NCT06498297招募中不适用

Analysis of the Impact of a Temporo-spatial Reorientation Tool on the Speed of Improvement of Confusional Syndrome, Assessed by the 4 "A" Test, in Patients Aged Over 75 Years Hospitalized in the Medical and Health Care Department. Geriatric Rehabilitation.

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2023年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Speed of improvement of the 4AT of the entire population

研究概览

简要总结

Confusion syndrome is defined by attentional disorders and disorganization of cognitive functions that are acute and reversible. There are patient-specific predisposing factors and precipitating factors. Elderly people, due to their comorbidities, are more at risk. Confusion syndrome affects approximately 23% of elderly patients in the medical department, 33% in the rehabilitation department and its occurrence is preventable in 30 to 40% of cases. The health expenditure generated by its occurrence was estimated at 182 billion dollars per year by combining the expenditure of 18 European countries in 2011. The occurrence of a delirium increases the duration of hospitalization, increases the risk of falls, loss of autonomy, can lead to an impairment of quality of life at 6 months and is linked to excess mortality.

The gold standard for making the diagnosis of delirium is the use of the DSM-5 criteria, but their use is time-consuming and requires that staff be trained in their use. The 4 "A" test (tool to help identify confusional syndrome) can be used to monitor confusional syndromes; it has the advantage of being able to be taken in less than 3 minutes.

Concerning the management of a confusional syndrome, a non-pharmacological multi-component approach is recommended as first line for its prevention but there is no treatment to date. A tool to help with temporo-spatial reorientation (La Rob'Gazette) has been set up in the Medical Care and Geriatric Rehabilitation (SMRG) departments of the HUS

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Patient aged 75 and over
  • Hospitalized at the HUS in the SMRG department during the period from January 1, 2021 to April 31, 2023
  • Passed at least a 4AT during hospitalization
  • Absence of written opposition in the patient's medical file (and/or their legal representative if applicable) to the reuse of their data for scientific research purposes.

排除标准

  • Presence of written opposition from the patient (and/or their legal representative if applicable) in their medical file.

结局指标

主要结局

Speed of improvement of the 4AT of the entire population

时间窗: Up to 2 years

The analysis will be undertaken on patients for whom at least two 4AT measurements are available (in order to be able to calculate a change). It will be based on a mixed linear model including the variable to be tested, time and their interaction. Variables deemed clinically relevant or statistically significant at the threshold of p \< 0.10 will be included in a multivariate model. Then the non-significant and irrelevant variables will be removed from the model. The significance threshold will be 0.05 for this final model.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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