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

NCT02708823 | Completed

• 1 other identifier: CogCheck-Norm
• Study Type: observational
• Target: 334
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Postoperative delirium; Risk assessment; Clinical screening tool; Tablet computer

Outcome Measures

Primary Outcomes (1)

• CogCheck

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

  Baseline.

Secondary Outcomes (3)

• Mini-Mental State Examination (MMSE)

  Baseline.

• Geriatric Depression Scale (GDS)

  Baseline.

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

  Baseline.

Interventions

CogCheck application OTHER

The application is administered once to all study participants.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Non-surgical, cognitively healthy volunteers

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nicolai Goettel: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Delirium; Emergence Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes

Study Officials

• Nicolai Goettel, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 15, 2016
• Study Start: December 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 25, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)