Clinical trial NCT04493996: Increasing Preoperative Cognitive Reserve to Prevent Postoperative Cognitive Dysfunction in Cardiac Surgical Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Cognitive Decline
Postoperative Delirium
Postoperative Cognitive Dysfunction
Keywords: Cardiac Surgery
Postoperative Cognitive Decline
Postoperative Delirium
Cognitive Training
Cognitive Reserve
Postoperative Cognitive Dysfunction
Lead sponsor: Heart and Brain Research Group, Germany
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: 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
timeFrame: Immediately pre-training to 3 month post-surgery
measure: 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"
timeFrame: Immediately pre-training to approximately 1 week post-surgery
measure: Number of participants with postoperative delirium during the stay in the intensive care unit as assessed using the "Intensive Care Delirium Screening Checklist" (ICDSC)
timeFrame: Immediately post-surgery to approximately 1-2 days post-surgery
measure: Number of participants with postoperative delirium during the stay on normal ward as assessed using the "Confusion Assessment Method" (3D-CAM)
timeFrame: Approximately 1 week (Immediately post-intensive care unit to approximately 1 week post-intensive care unit)
Secondary outcomes:
measure: Change from baseline cognitive failures in everyday life at 3 months after surgery as assessed using the "Cognitive Failures Questionnaire" (CFQ)
timeFrame: Immediately pre-training to 3 month post-surgery
measure: Change from baseline health-related quality of life at 3 months after surgery as assessed using the "36-Item Short Form Health Survey" (SF36)
timeFrame: Immediately pre-training to 3 month post-surgery
measure: Change from baseline visual immediate memory span at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
measure: Change from baseline visual free recall at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
measure: Change from baseline visual recognition memory at the end of cognitive training as assessed using the "Brief Visuospatial Memory Test-Revised" (BVMT-R)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
measure: Change from baseline verbal immediate memory span at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
measure: Change from baseline verbal free recall at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
measure: Change from baseline verbal recognition memory at the end of cognitive training as assessed using the "Verbaler Lern- und Merkfähigkeitstest" (VLMT)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
measure: Change from baseline selective attention at the end of cognitive training as assessed using the "Trail Making Test A" (TMT)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
measure: Change from baseline verbal working memory at the end of cognitive training as assessed using the "Letter Number Span Test" (LNS)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
measure: Change from baseline cognitive flexibility at the end of cognitive training as assessed using the "Trail Making Test B" (TMT)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
measure: Change from baseline inhibition at the end of cognitive training as assessed using the "Syndrom-Kurz Test" (SKT-7)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
measure: Change from baseline word fluency at the end of cognitive training as assessed using the "Regensburger Wortflüssigkeits-Test" (RWT)
timeFrame: Immediately pre-training to approximately 2-3 weeks post-training
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Department of Cardiac Surgery, Kerckhoff-Klinik GmbH
Study officials:
affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
name: Marius Butz, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic for Neurology, University Hospital Gießen
name: Martin Jünemann, Dr.med,M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurology, Gesundheitszentrum Wetterau
name: Tibo Gerriets, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim
name: Markus Schönburg, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: