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

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

Sponsors

Lead Sponsor: Heart and Brain Research Group, Germany

Source Heart and Brain Research Group, Germany
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.

Overall Status Not yet recruiting
Start Date August 2020
Completion Date November 2022
Primary Completion Date November 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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 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" 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) 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) Approximately 1 week (Immediately post-intensive care unit to approximately 1 week post-intensive care unit)
Secondary Outcome
Measure Time Frame
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 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 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 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
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
Enrollment 100
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Cognitive training

Description: 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

Arm Group Label: Cognitive training group

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Marius Butz, Dipl.-Psych.

Phone: +496032 996 5812

Email: [email protected]

Location
Facility: Contact: Department of Cardiac Surgery, Kerckhoff-Klinik GmbH Marius Butz +496032 996 5812 [email protected]
Location Countries

Germany

Verification Date

July 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Cognitive training group

Type: Experimental

Label: Control group

Type: No Intervention

Acronym INCORE
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov