Increasing Preoperative Cognitive Reserve to Prevent Postoperative Cognitive Dysfunction in Cardiac Surgical Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cognitive training.
- Who it may be relevant to
- Registry conditions: Postoperative Cognitive Decline, Postoperative Delirium, Postoperative Cognitive Dysfunction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Increasing Preoperative Cognitive Reserve to Prevent Postoperative Delirium and Postoperative Cognitive Decline in Cardiac Surgical Patients. A Randomized Controlled Trial on Cognitive Training
Overview
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.
Detailed description
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.
Interventions
- Behavioral 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
Primary outcome measures
- 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 [Time frame: 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" [Time frame: 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) [Time frame: 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) [Time frame: Approximately 1 week (Immediately post-intensive care unit to approximately 1 week post-intensive care unit)]
Secondary outcome measures (12)
- Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the "Cognitive Failures Questionnaire" (CFQ) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: Immediately pre-training to approximately 2-3 weeks post-training]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- History of stroke and preexisting psychiatric or neurological disorders that may impair the neuropsychological performance
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Germany · 1 center
- Department of Cardiac Surgery, Kerckhoff-Klinik GmbH — Bad Nauheim
Identifiers
NCT: NCT04493996 · 48/20