Department of Cardiac Surgery, Kerckhoff-Klinik GmbH
Bad Nauheim, 61231, Germany
Location status: Recruiting
NCT Number: NCT04493996
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Bad Nauheim, 61231, Germany
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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).
Time frame: Immediately pre-training to approximately 1 week post-surgery
The "Montreal Cognitive Assessment" (MOCA) is a screening procedure for general cognitive function.
Time frame: 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.
Time frame: 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.
Time frame: Immediately pre-training to 3 month post-surgery
The "Cognitive Failures Questionnaire" (CFQ) measure the frequency of failures in daily living in terms of memory, attention, action, and perception.
Time frame: Immediately pre-training to 3 month post-surgery
The "36-Item Short Form Health Survey" (SF36) includes 36 questions covering 8 health-related factors: vitality, physical functioning, bodily pain, general health perception, physical role function, emotional role function, social role functioning, and mental health.
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
In the "Brief Visuospatial Memory Test-Revised" (BVMT-R), the patient is shown six geometric figures for 10 seconds on a DIN A4 sheet of paper, which are to be drawn directly afterward. This procedure is repeated with the same figures in a total of three learning trials. The figures are to be freely replicated in a time-delayed episode with following recognition help.
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
In the "Verbaler Lern- und Merkfähigkeitstest" (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
In the "Verbaler Lern- und Merkfähigkeitstest" (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
In the "Verbaler Lern- und Merkfähigkeitstest" (VLMT), a list of words is learned over five learning trials, which, after a interference word list, is to be remembered directly and with a delay of about 20 minutes. With subsequent recognition help, the verbal discrimination ability is measured.
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
In the "Trail Making Test A" (TMT-A), the patient has to connect numbers in ascending order on a test sheet as fast as possible.
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
In the "Letter Number Span Test" (LNS), the patient is supposed to rearrange a mixed sequence of letters and numbers through mental reorganization in such a way that first all numbers and then all letters are to be named in ascending order.
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
With the "Trail Making Test B" (TMT-B), the patient's task is to connect numbers and letters alternately in ascending order.
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
In the "Syndrom-Kurz Test" (SKT-7), the patient has to rename a series of letters (e.g., "A" instead of "B," and vice versa).
Time frame: Immediately pre-training to approximately 2-3 weeks post-training
In the "Regensburger Wortflüssigkeits-Test" (RWT), the patient has to name in one minute as many words as possible from a certain category.
Contact information is provided by the study sponsor or research team.
Marius Butz, Dipl.-Psych.
CONTACT
Martin Jünemann, Dr.med,M.Sc.
CONTACT
Heart and Brain Research Group, Germany
Other
Increasing Preoperative Cognitive Reserve to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Cognitive Training
Acronym: INCORE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07217912
Alzheimer Disease, Brain Diseases
Rochester, New York, United States
View Trial DetailsNCT06630390
Alzheimer Disease, Brain Diseases
Rochester, New York, United States
View Trial DetailsNCT06042413
Brain Diseases, Central Nervous System Diseases
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT05361460
Biomarkers, Cognition Disorders
Stockholm, Sweden
View Trial Details