Departamento de Medicina, Servicio de Medicina Física y Rehabilitación, Hospital Clínico de La Universidad de Chile, Dr. Carlos Lorca Tobar #999, 8380456, Independencia-Santiago, Chile.
Departamento de Terapia Ocupacional y Ciencia de La Ocupación, Facultad de Medicina, Universidad de Chile, Av. Independencia #1027, 8380453, Independencia-Santiago, Chile.
BMC Geriatr. 2023 Aug 5;23(1):472. doi: 10.1186/s12877-023-04189-2.
Delirium is a clinical condition characterised by acute and fluctuating deterioration of the cognitive state, generally secondary to an acute pathology. Delirium is associated with negative outcomes in older adults, such as longer hospitalisations, higher mortality, and short and medium-term institutionalisation. Randomised clinical trials have shown that delirium is preventable through non-pharmacological prevention measures, decreasing its incidence by 30-50%. These interventions include promoting physical activity, facilitating the use of glasses and hearing aids, cognitive stimulation, and providing frequent reorientation of time and space, among others. These measures are currently seldom applied in hospitals in Chile and around the world for reasons including the heavy workload of clinical staff, the lack of trained personnel, and in general the absence of a systematic implementation processes. We developed a software called PREVEDEL, which includes non-pharmacological strategies such as cognitive stimulation, early mobilisation, orientation, and pain assessment. We propose a randomised clinical trial to evaluate whether cognitive stimulation guided by PREVEDEL software prevents delirium status (full/subsyndromal delirium) in hospitalised older adults.
A randomised controlled trial, with parallel, multicentre groups. We will recruite patients 65 years or older who have been hospitalised for less than 48 h in the general ward or the intermediate care units of four hospitals in Santiago, Chile. The participants in the intervention group will use a tablet with cognitive stimulation software for delirium prevention for five continuous days versus the control group who will use the tablet without the software. We will evaluate the incidence, duration, density of delirium, subsyndromal delirium with the Confusion Assessment Method, cognitive with the Montreal Cognitive Assessment, and functional status with the Functional Independence Measure at discharge. Moreover, we will evaluate the adherence to prevention measures, as well as demographic variables of interest.
The use of cognitive PREVEDEL software could increase and improve the implementation of non-pharmacological prevention measures for delirium in hospitalised older adults, thus reducing its incidence and contributing to patients and health professionals.
NCT05108207 ClinicalTrials.gov. Registered 4 November 2021.
谵妄是一种以认知状态急性和波动性恶化为特征的临床病症，通常继发于急性疾病。谵妄与老年人的不良结局相关，例如住院时间延长、死亡率增加以及短期和中期的机构化。随机临床试验表明，通过非药物预防措施可以预防谵妄，使其发病率降低 30-50%。这些干预措施包括促进身体活动、促进眼镜和助听器的使用、认知刺激以及提供频繁的时间和空间定向等。目前，智利和世界各地的医院很少应用这些措施，原因包括临床工作人员工作量大、缺乏训练有素的人员以及缺乏系统的实施流程等。我们开发了一种名为 PREVEDEL 的软件，其中包括认知刺激、早期动员、定向和疼痛评估等非药物策略。我们提出了一项随机临床试验，以评估 PREVEDEL 软件指导的认知刺激是否可以预防住院老年人的谵妄状态（全面/亚综合征性谵妄）。
一项随机对照试验，采用平行、多中心分组。我们将招募年龄在 65 岁或以上、在智利圣地亚哥的四家医院的普通病房或中级护理病房住院时间少于 48 小时的患者。干预组的参与者将使用平板电脑上的认知刺激软件进行为期五天的连续预防谵妄，而对照组则使用没有软件的平板电脑。我们将评估谵妄的发生率、持续时间、密度、使用谵妄评估方法评估的亚综合征性谵妄、使用蒙特利尔认知评估评估的认知功能、以及出院时的功能独立性量表评估的功能状态。此外，我们将评估预防措施的依从性以及感兴趣的人口统计学变量。
使用认知 PREVEDEL 软件可以增加和改善对住院老年人进行的非药物预防谵妄措施的实施，从而降低其发病率，并为患者和卫生专业人员带来益处。
NCT05108207 ClinicalTrials.gov。于 2021 年 11 月 4 日注册。
