Clinical trial NCT02708823: Standardization of a Novel Self-administered Tablet Computer-based Clinical Screening Tool for Adverse Postoperative Cognitive Outcomes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Postoperative delirium
Risk assessment
Clinical screening tool
Tablet computer
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2016-03-15
Enrollment: 334
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-surgical, cognitively healthy volunteers

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.

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.

Primary outcomes:
measure: CogCheck
timeFrame: Baseline.
Secondary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: Baseline.
measure: Geriatric Depression Scale (GDS)
timeFrame: Baseline.
measure: Consortium to Establish a Registry for Alzheimer's Disease - Neuropsychological Assessment Battery (CERAD-NAB)
timeFrame: Baseline.
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Nicolai Goettel, MD
role: PRINCIPAL_INVESTIGATOR
References: