Standardization of a Novel Self-administered Tablet Computer-based Clinical Screening Tool for Adverse Postoperative Cognitive Outcomes

NCT ID: NCT02708823

Last Updated: 2018-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 334 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-04-30

Brief Summary

Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) are common complications after surgery and may affect elderly patients in particular. CogCheck, an application for tablet computers, was developed with the intention to assist preoperative risk screening for POD and POCD in surgical patients. The aim of this study is to generate normative data with cognitively healthy participants for the application.

Detailed Description

Postoperative delirium (POD) and postoperative cognitive dysfunction (POCD) are common complications after surgery and may affect elderly patients in particular. Prior studies found risk factors for POD and POCD which are present preoperatively, e.g. older age and pre-existing cognitive impairment. However, the preoperative risk of postoperative adverse cognitive outcomes (POD and POCD) is often not screened in routine clinical practice as it is time-consuming and requires trained personnel.

In 2014, the application for tablet computers "Delirium Risk Profile" (DRP) was developed at the University Hospital Basel to assist preoperative screening in surgical patients. The application was later renamed CogCheck as the scope of the tool was extended to POD and POCD risk assessment.

The aim of this study is to provide normative data for the application. Ultimately, the objective is to assist health care providers in the evaluation of patients' cognitive functions by routinely using the application in preoperative clinics.

Conditions

Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

CogCheck application

The application is administered once to all study participants.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 65 years
• Education ≥ 7 years
• Fluency in the German language
• Written informed consent

Exclusion Criteria

• History of cognitive impairment
• Signs of depression
• Severe sensory or motor impairment interfering with cognitive testing
• Serious somatic disease, disease or event affecting the central nervous system (head trauma with loss of consciousness > 5 minutes, any brain surgery, general anesthesia within the last 3 months, alcoholism, intoxication with neurotoxic substances)
• Cerebrovascular disease
• Regular medication with psychoactive drugs except for benzodiazepines
• Participation in any cognitive study within the last 3 months or previous participation in a study using the application.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nicolai Goettel

OTHER

Sponsor Role: lead

Responsible Party

Nicolai Goettel

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicolai Goettel, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

CogCheck-Norm

Identifier Type: -

Identifier Source: org_study_id