Delirium Clinical Trial
— CogCheck-NormOfficial 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
Verified date | April 2018 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
Nicolai Goettel |
Switzerland,
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. |
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