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

April 24, 2018 updated by: Nicolai Goettel

Standardization of a Novel Self-administered Tablet Computer-based Clinical Screening Tool for Adverse Postoperative Cognitive Outcomes: A Neuropsychological Study in Non-surgical Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

334

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Non-surgical, cognitively healthy volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CogCheck
Time Frame: Baseline.
Score in a self-administered tablet computer-based neuropsychological assessment.
Baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-Mental State Examination (MMSE)
Time Frame: Baseline.
Obtained score in MMSE.
Baseline.
Geriatric Depression Scale (GDS)
Time Frame: Baseline.
Obtained score in GDS.
Baseline.
Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)
Time Frame: Baseline.
Obtained score in CERAD-NAB.
Baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicolai Goettel

Investigators

  • Principal Investigator: Nicolai Goettel, MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 4, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Actual)

April 25, 2018

Last Update Submitted That Met QC Criteria

April 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CogCheck-Norm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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