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临床试验/NCT06809894
NCT06809894尚未招募不适用

Improvement of the Delirium Management in Adult Patients Hospitalized Through the Use of Non-pharmacological Interventions

Universitat de Lleida1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2026年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
65
试验地点
1
主要终点
Rate of patients who develop delirium

研究概览

简要总结

Application of an action protocol focused on the application of non-pharmacological interventions for managing delirium in the process of prevention, diagnosis and treatment, evaluated using an e-health intervention, with a tablet to introduce on it the data about the prevention, diagnostic and treatment process of each recluted patient, in the Igualada Hospital Center, once a day.

详细描述

  1. Generalities Delirium, also known as acute confusional syndrome (ACS), is one of the most common complications in hospitalized patients because its underdiagnosed, increased dependence on basic activities of daily living (ADLs), morbidity and mortality, with nearly 23 deaths per 100 patients diagnosed with delirium. It affects up to 40% of patients over 65 years of age.

Its occurrence is more frequent in specific hospital settings, such as intensive care units (ICU), emergency departments, or units treating respiratory conditions.

Several risk factors contribute to the development of delirium, including age (patients over 65 are at higher risk), gender (it is more common in men), polypharmacy, and invasive procedures like bladder catheterization. Patients with urinary tract infections (UTIs) or strictures also face an increased risk.

In addition, comorbidities like diabetes, stroke, heart failure, or COPD increases the risk of tdeveloping delirium.

The duration of delirium symptoms can be hours to days, in the 80% of cases, and 20% lasting weeks or even months (4).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
80 Years 至 130 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age over 80 years
  • •Three risk factor to develop delirium, for example: sex (men), polypharmacy,urinary tract infections (UTIs) or strictures.
  • •Admission in geriatric unit.
  • •Have social support

排除标准

  • •Age under 80 years
  • •Eseeable death on admission not caused by delirium or delirium diagnosis on admission.

研究组 & 干预措施

Quantitative study for the evaluation of the protocol's effectiveness

Experimental

A quantitative study is carried out in which the indices described in the description of the study are studied in order to assess the effectiveness of the implementation of delirium.

干预措施: Application of an action protocol for the management of delirium through the use of non-pharmacological interventions (Procedure)

Traditional ways to delirium management

Active Comparator

The use of traditional ways to manage the delirium in hosoitalized older patient, based especially in the use of pharmacological interventions and mechanical patient restraint were compared with the new interventions includes in the new protocol to valorate the effectiveness of the new way to management delirium based in non-pharmacological interventions.

干预措施: Tradicional management of delirium (Other)

结局指标

主要结局

Rate of patients who develop delirium

时间窗: Its calculation is carried out during the 3 months of the study, and within each particular case, It is carried out in the morning every day, from admission to discharge of the patient, up to 3 days.

It is performed on all patients admitted to geriatric unit with 3 or more risk criteria for the development of delirium. Its measurement is carried out in the morning shift using the Confussional Assesment Scale scale. The score is from 0 to 4 points, with a positive diagnosis being one with a score greater than 2. It compares the incidence of the control group and the intervention group.

Rate of patients diagnosed with delirium improving clinical severity

时间窗: Its calculation is carried out during the three months of the study, and within each particular case, in the morning every day, from the beginning of diagnosis to the improvement of the patient, up to 3 days.

Every patient with a positive diagnostic and an active treatment. The objective is to avaluate the reduction of the symptoms with the Delirium Rating Scale-R-98 scale, in the morning, comparing control gropu and interventional group . The score is from 0 to 48 points, with a positive diagnosis with severity symptoms in scores greater than 12 points.

Drug use rate for the treatment of delirium

时间窗: Its calculation is carried out during the 3 months of the study, and within each particular case, in the end of the patient hospitalitzation, up to 3 days.

Carried out with the recorded on the e-health program and the observation of the clinical history of each patient who have had a positive diagnosis of delirium in their hospitalitzation in the geriatric unit and has recorded the use of drugs, like number of a day and type of drug, for their treatment. Comparation control group and intervention group.

次要结局

未报告次要终点

研究者

发起方
Universitat de Lleida
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laia Fernandez Parra

Registred Nurse (RN) and MSc

Universitat de Lleida

研究点 (1)

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