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Completed

NCT Number: NCT02708823

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CogCheck application

Other

The application is administered once to all study participants.

Primary outcomes

  1. CogCheck

    Time frame: Baseline.

    Score in a self-administered tablet computer-based neuropsychological assessment.

Secondary outcomes

  1. Mini-Mental State Examination (MMSE)

    Time frame: Baseline.

    Obtained score in MMSE.

  2. Geriatric Depression Scale (GDS)

    Time frame: Baseline.

    Obtained score in GDS.

  3. Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)

    Time frame: Baseline.

    Obtained score in CERAD-NAB.

Sponsors and collaborators

Lead sponsor

Nicolai Goettel

Other

Registry information

Official study title

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

Acronym: CogCheck-Norm

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 15, 2016
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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