Postoperative Cognitive Training for the Prevention of Delirium in Older Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 主要终点
- Postoperative delirium within the first five days after surgery
研究概览
简要总结
The aim of this clinical trial is to test whether daily postoperative cognitive training can prevent delirium in older patients after major surgery.
The main questions to be answered is:
Can daily cognitive training reduce the rate of postoperative delirium in older patients after surgery?
Participants will be visited daily for the first 5 days after surgery and asked to take part in a tablet-based cognitive training programme for 2 hours a day (in 2 sessions).
The researchers will compare patients who receive the training with a control group of patients who listen to audio books for the same amount of time and a control group who receive standard care (no intervention).
详细描述
The most common postoperative complication in aged patients is postoperative delirium (POD), which often progresses to permanent postoperative neurocognitive disorder (pNCD). POD and pNCD are associated with significantly increased postoperative morbidity and mortality. Prevention of POD is therefore a primary therapeutic goal in the care of elderly patients. The aim of this project is to investigate the effect of cognitive stimulation on the occurrence of POD in older patients at risk after surgery.
Patients undergoing surgery who are at least 70 years old and have an increased risk of postoperative delirium will be included. The increased risk will be assessed in a preoperative assessment as part of the anaesthetic premedication consultation. It is defined as the presence of frailty (Clinical Frailty Scale, CFS and Longitudinal Urban Cohort Study Age Function Index, LUCAS-FI), cognitive impairment (Montreal Cognition Assessment Test, MoCA) or increased morbidity (Hall Risk Analysis Index). The intervention takes the form of computer-based cognitive training in the areas of attention, processing speed, memory, emotional intelligence, reasoning and orientation. Positive effects of this training have already been shown in the treatment of mild cognitive impairment (MCI), dementia and tumour-related cognitive impairment.
The training takes place under supervision for 120 minutes a day from the first to the fifth postoperative day. It is hypothesised that postoperative cognitive training can reduce the incidence of delirium in the first five days after surgery. Secondary endpoints are the reduction of neurocognitive dysfunction at one week, six weeks and six months after surgery, maintenance of function and quality of life at six months.
In order to adjust for the stimulating effects of interacting with study staff during the study visits, a control group listening to an audio book (also brought and set up by study staff) is included in the trial.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 70 years or older,
- •planned surgery (abdominal surgery: general surgery, urology or gynaecology; spinal surgery, vascular medicine, cardiothoracic surgery, major trauma surgery),
- •increased perioperative risk (frailty, cognitive impairment, multimorbidity).
排除标准
- •Unable to give consent,
- •severe cognitive disorder or mental retardation (if training cannot be carried out)
- •Insufficient knowledge of German
研究组 & 干预措施
Intervention
Tablet-based bed-side cognitive training for 2h per day for the first five days after surgery (or until discharge from hospital, if earlier).
干预措施: Cognitive training (Behavioral)
Audio book
Listening to an audio book for 2h per day for the first five days after surgery (or until discharge from hospital, if earlier).
干预措施: Listen to audio book (Behavioral)
Standard care
Standard care without any intervention.
结局指标
主要结局
Postoperative delirium within the first five days after surgery
时间窗: delirium screening twice daily from postoperative day 1-5
Delirium screened twice daily using the 3D-Confusion Assessment Method (3D-CAM) for the first five days after surgery (0-4 hallmarks; hallmark 1+2 and 3+4 = delirium)
次要结局
- postoperative neurocognitive disorder(6 months after surgery)
- Functional state (patient-reported)(6 months after surgery)
- Functional state (measured)(6 months after surgery)
- Quality of Life (by questionnaire)(6 months after surgery)
- Quality of Life (by visual analogue scale)(6 months after surgery)
- postoperative neurocognitive disorder(postoperative day 7 (1 week after surgery))
- postoperative neurocognitive disorder(6 weeks after surgery)
- Functional state (patient-reported)(6 weeks after surgery)
- Functional state (measured)(6 weeks after surgery)
- Quality of Life (by questionnaire)(6 weeks after surgery)
- Quality of Life (by visual analogue scale)(6 weeks after surgery)