Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Postoperative Cognitive Decline
  • Postoperative Cognitive Dysfunction
  • Postoperative Delirium
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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-an...

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.

Tracking Information

NCT #
NCT04493996
Collaborators
Not Provided
Investigators
Principal Investigator: Marius Butz, Dipl.-Psych. Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim Principal Investigator: Martin Jünemann, Dr.med,M.Sc. Clinic for Neurology, University Hospital Gießen Principal Investigator: Tibo Gerriets, Prof.Dr.med. Department of Neurology, Gesundheitszentrum Wetterau Principal Investigator: Markus Schönburg, Prof.Dr.med. Department of Cardiac Surgery, Kerckhoff Clinic Bad Nauheim