Increasing Preoperative Cognitive Reserve to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Cognitive Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
研究概览
简要总结
Postoperative delirium (POD) and postoperative cognitive decline (POCD) can be observed after cardiosurgical interventions. Taken together, these postoperative neurocognitive dysfunctions contribute to increased morbidity and mortality and higher economic costs. Preoperative risk factors of postoperative neurocognitive dysfunctions, such as decreased neuropsychometric performance or decreased cognitive daily activities, can be interpreted as reduced cognitive reserve. The aim of this study is to build up cognitive reserves to protect against the development of POD and POCD through preoperative, home-based, cognitive training.
详细描述
The planned research project is a monocentric, 2-arm randomized controlled intervention study involving 100 patients undergoing elective cardiac surgery with extracorporeal circulation. Patients will be assigned to a training group or control group. The intervention involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for approximately 40 minutes per day over a preoperative period of 2-3 weeks. The control group will receive neither cognitive training nor a placebo intervention. A detailed assessment of psychological functions will be performed approximately 2-3 weeks before the start of training, at the end of the training, during hospitalization, at discharge from the acute clinic, and 3 months after surgery. The primary objective of this study is to investigate the interventional effect of preoperative cognitive training on the incidence of POD during the stay in the acute clinic, the incidence of POCD at the time of discharge from the acute clinic, and 3 months after surgery. Secondary objectives are to determine the training effect on objective cognitive functions before the surgery and subjective cognitive functions, as well as health-related quality of life 3 months after surgery.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective cardiac surgery (coronary artery bypass surgery, aortic or mitral valve replacement/reconstruction, or combination surgery) with standardized extracorporeal circulation
- •A sufficiently good knowledge of German is necessary as cognitive training and neuropsychological tests are language-dependent
排除标准
- •History of stroke and preexisting psychiatric or neurological disorders that may impair the neuropsychological performance
研究组 & 干预措施
Cognitive training group
干预措施: Cognitive training (Behavioral)
Control group
结局指标
主要结局
Number of participants with postoperative cognitive decline at 3 months after surgery, defined as a decrease between pre- and postoperative examinations of one standard deviation in at least 20% of all objective neuropsychological parameters
时间窗: Immediately pre-training to 3 month post-surgery
The objective neuropsychological parameters measure cognitive domains like Immediate memory span, free recall, recognition memory, selective attention, working memory, inhibition and word fluency. These cognitive domains will be measured with the following instruments: "Verbaler Lern- und Merkfähigkeitstest" (VLMT), "Brief Visuospatial Memory Test-Revised" (BVMT-R), "Trail Making Test A/B" (TMT), "Letter Number Span Test" (LNS), "Regensburger Wortflüssigkeits-Test" (RWT), and "Syndrom-Kurz Test" (SKT-7).
Number of participants with postoperative cognitive decline at the time of discharge from the acute clinic, defined as a decrease between the pre- and postoperative examinations of one standard deviation measured with the "Montreal Cognitive Assessment"
时间窗: Immediately pre-training to approximately 1 week post-surgery
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
Number of participants with postoperative delirium during the stay in the intensive care unit as assessed using the "Intensive Care Delirium Screening Checklist" (ICDSC)
时间窗: Immediately post-surgery to approximately 1-2 days post-surgery
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in the intensive care unit. The "Intensive Care Delirium Screening Checklist" (ICDSC) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM)
时间窗: Approximately 1 week (Immediately post-intensive care unit to approximately 1 week post-intensive care unit)
Postoperative delirium is defined as the occurrence of at least one delirious episode during a stay in an intensive care unit or normal ward. The "Confusion Assessment Method" (3D-CAM) record the clinical symptoms of consciousness, attention, orientation, hallucinations, psychomotor retardation or agitation, speech, and changing symptoms by observing behavior and asking concrete questions to the patient.
次要结局
- Change from baseline visual immediate memory span at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)(Immediately pre-training to approximately 2-3 weeks post-training)
- Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the "Cognitive Failures Questionnaire" (CFQ)(Immediately pre-training to 3 month post-surgery)
- Change from baseline health-related quality of life at 3 months after surgery as assessed using the "36-Item Short Form Health Survey" (SF36)(Immediately pre-training to 3 month post-surgery)
- Change from baseline visual free recall at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)(Immediately pre-training to approximately 2-3 weeks post-training)
- Change from baseline visual recognition memory at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)(Immediately pre-training to approximately 2-3 weeks post-training)
- Change from baseline verbal immediate memory span at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)(Immediately pre-training to approximately 2-3 weeks post-training)
- Change from baseline word fluency at the end of cognitive training as assessed using the "Regensburger Wortflüssigkeits-Test" (RWT)(Immediately pre-training to approximately 2-3 weeks post-training)
- Change from baseline verbal free recall at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)(Immediately pre-training to approximately 2-3 weeks post-training)
- Change from baseline verbal recognition memory at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)(Immediately pre-training to approximately 2-3 weeks post-training)
- Change from baseline selective attention at the end of cognitive training as assessed using the "Trail Making Test A" (TMT)(Immediately pre-training to approximately 2-3 weeks post-training)
- Change from baseline verbal working memory at the end of cognitive training as assessed using the "Letter Number Span Test" (LNS)(Immediately pre-training to approximately 2-3 weeks post-training)
- Change from baseline cognitive flexibility at the end of cognitive training as assessed using the "Trail Making Test B" (TMT)(Immediately pre-training to approximately 2-3 weeks post-training)
- Change from baseline inhibition at the end of cognitive training as assessed using the "Syndrom-Kurz Test" (SKT-7)(Immediately pre-training to approximately 2-3 weeks post-training)