Software-guided Cognitive Stimulation Prevents the Development of Delirium in Hospitalized Older Adults: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Delirium Status (delirium and subsyndromal delirium)
研究概览
简要总结
Background
Delirium, is a clinical condition characterized by acute and fluctuating deterioration of the cognitive state, generally secondary to an acute pathology. It is a common condition in hospitalized older adults and it develops in 20-30% of patients hospitalized in a general ward and up to 80% of those hospitalized in critical care units. Delirium is associated with negative outcomes in older adults, such as longer hospitalizations, higher mortality, and short and medium-term institutionalization. Randomized clinical trials have shown that delirium is preventable through non-pharmacological prevention measures, decreasing its incidence by 30 to 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 various reasons some of which include the heavy workload of clinical staff, the lack of trained personnel, and, in general, the absence of systematic implementation processes.
The main objective is to evaluate whether cognitive stimulation guided by PREVEDEL software prevents delirium status(full/subsyncromal delirium) in hospitalized older adults.
Method/Design: randomized controlled trial, parallel groups, multicenter.
Participants: patients 65 years or older who have been hospitalized for less than 48 hours in the general ward or in the intermediate care unit of 4 hospitals in Santiago, Chile.
Intervention: participants in the intervention group will use a tablet with cognitive stimulation software for delirium prevention for 5 continuous days versus the control group who will use the tablet without the software.
Evaluations: The incidence of delirium and subsyndromal delirium, duration, density of delirium, cognitive and functional status at discharge, adherence to prevention measures, as well as demographic variables of interest will be evaluated.
详细描述
Background. Delirium is a clinical condition characterized by acute cognitive impairment, of fluctuating course, generally secondary to an acute pathology, which appears after the interaction between predisposing factors and well described precipitants. It is a very common condition in older adults, observed in 20% to 30% of patients hospitalized in a general ward, and up to 80% of those hospitalized in critical care units. Delirium is associated with negative clinical outcomes which include longer hospitalizations, increased direct and indirect costs, functional impairment, greater risk of mortality, increased risk of institutionalization, and deterioration in long-term cognitive status, among others.
Subsyndromal delirium (SSD) is a milder state characterised by the presence of certain delirium symptoms but without meeting full diagnostic criteria thresholds, is also associated with poor posthospitalization outcomes similar to those associated with delirium. The reported frequency of subsyndromal delirium varies (7-50%) according to the definition applied and the clinical population studied. Its incidence in the general medicine ward is 17%.
The frequency of delirium status (full/subsyndromal delirium) in the general room is approximately 25%.
It is known that delirium in hospitalized older adults is preventable. In multiple randomized clinical trials, non-pharmacological interventions to prevent delirium (nPPD), shown to reduce its incidence by 30-50%7.
Despite the high evidence supporting them, non-pharmacological interventions to prevent delirium are poorly implemented in hospitals in Chile and around the world for several reasons, such as the heavy workload of clinical staff, lack of trained personnel, and, in general, the absence of systematic implementation processes.
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
- Single (Outcomes Assessor)
盲法说明
The enrollers, evaluators and healthcare personnel (nurses, physical therapists, physicians, occupational therapists) do not know the assigned group. Both groups receive a tablet of the same dimensions and with the same basic applications. However, blinding the patient is not possible, since when exploring the tablet, he or she will recognize whether or not it has the PREVEDEL program included. To reduce this bias, the staff that delivers the tablet encourages both groups to use its different basic applications (access the Internet) and that any doubts may have participants about its use should be made to the tablet coordinator, so that the evaluators or healthcare personnel remain masked.
The time between assignment and delivery of the tablet is between 4 to 12 hours in all participating centers. This variable will be measured for later analysis.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 65 years or older.
- •Hospitalized less than an 48 hours ago in a general ward or in the intermediate care unit. Participating health center: 1) Hospital Clínico de la Universidad de Chile, 2) Hospital San Juan de Dios, 3) Clínica Las Condes, 4) Hospital Santiago Oriente Dr Luis Tisné.
排除标准
- •Presence of full or syndromal delirium (CAM+ or presence of one core elements).
- •History of dementia (AD8 greater than 2 points).
- •Non-Spanish speaking patients.
结局指标
主要结局
Delirium Status (delirium and subsyndromal delirium)
时间窗: 5 days
To evaluate the incidence of delirium and incidence of subsyndromal with Confusion Assessment Method (CAM).
次要结局
- Cognitive level(At day 0 and 5.)
- Adherence to prevention measures(At day 0 and 30 (before and after training in prevention measure).)
- Hospital stay(Through study completion an average of 30 days)
- Duration of delirium(5 days of protocol and 2 days of follow-up.)
- Level of independence in basic activities of daily living(At day 0 and 5.)
- Density of delirium(5 days.)
- 90-day mortality(At 90 day.)
- Time of use of electronic device(5 days)
- Difficulty falling and staying asleep due to device use.(Every day for 5 days.)
- Headache due to the device use.(Every day for 5 days.)
研究者
Eduardo Tobar
Eduardo Tobar, Associated professor
University of Chile