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

NCT ID: NCT04493996

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-14
• Study Completion Date: 2025-12-31

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.

Conditions

Postoperative Cognitive Decline; Postoperative Delirium; Postoperative Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Cognitive training group

Group Type: EXPERIMENTAL

Cognitive training

Intervention Type: BEHAVIORAL

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

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heart and Brain Research Group, Germany

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marius Butz, Dipl.-Psych.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim

Martin Jünemann, Dr.med,M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Clinic for Neurology, University Hospital Gießen

Tibo Gerriets, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Gesundheitszentrum Wetterau

Markus Schönburg, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim

Locations

Department of Cardiac Surgery, Kerckhoff-Klinik GmbH

Bad Nauheim, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Marius Butz, Dipl.-Psych.

Role: CONTACT

m.butz@kerckhoff-klinik.de

+496032 996 5812

Martin Jünemann, Dr.med,M.Sc.

Role: CONTACT

Martin.Juenemann@neuro.med.uni-giessen.de

+49641 98558917

Facility Contacts

Marius Butz

Role: primary

m.butz@kerckhoff-klinik.de

+496032 996 5812

Other Identifiers

48/20

Identifier Type: -

Identifier Source: org_study_id