Идёт набор NCT04493996

Increasing Preoperative Cognitive Reserve to Prevent Postoperative Cognitive Dysfunction in Cardiac Surgical Patients

Без фазы С лечением Postoperative Cognitive Decline Postoperative Delirium Postoperative Cognitive Dysfunction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Cognitive training.
Кому может быть актуально: Состояния в реестре: Postoperative Cognitive Decline, Postoperative Delirium, Postoperative Cognitive Dysfunction. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Increasing Preoperative Cognitive Reserve to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Cognitive Training

Обзор

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.

Подробное описание

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.

Вмешательства

Поведенческое Cognitive training
The cognitive training 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

Первичные конечные точки

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 [Срок оценки: Immediately pre-training to 3 month post-surgery]
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" [Срок оценки: Immediately pre-training to approximately 1 week post-surgery]
Number of participants with postoperative delirium during the stay in the intensive care unit as assessed using the "Intensive Care Delirium Screening Checklist" (ICDSC) [Срок оценки: Immediately post-surgery to approximately 1-2 days post-surgery]
Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM) [Срок оценки: Approximately 1 week (Immediately post-intensive care unit to approximately 1 week post-intensive care unit)]

Вторичные конечные точки (12)

Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the "Cognitive Failures Questionnaire" (CFQ) [Срок оценки: 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) [Срок оценки: Immediately pre-training to 3 month post-surgery]
Change from baseline visual immediate memory span at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R) [Срок оценки: Immediately pre-training to approximately 2-3 weeks post-training]
Change from baseline visual free recall at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Immediately pre-training to approximately 2-3 weeks post-training]

Критерии участия

Критерии включения

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