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

Delirium Clinical Trial

— CogCheck-Norm  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708823
• Other study ID #: CogCheck-Norm
• Status: Completed
• First received: March 4, 2016
• Last updated: April 24, 2018
• Start date: December 2016
• Est. completion date: April 2017

Study information

• Verified date: April 2018
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• CogCheck application
The application is administered once to all study participants.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Nicolai Goettel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CogCheck	Score in a self-administered tablet computer-based neuropsychological assessment.	Baseline.
Secondary	Mini-Mental State Examination (MMSE)	Obtained score in MMSE.	Baseline.
Secondary	Geriatric Depression Scale (GDS)	Obtained score in GDS.	Baseline.
Secondary	Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)	Obtained score in CERAD-NAB.	Baseline.