Standardization of a Novel Self-administered Tablet Compu... | NCT02708823

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

NCT02708823

Sponsor

Nicolai Goettel

Status

Completed

Last Update Posted

Apr 25, 2018Actual

Enrollment

334Actual

Phase

Not provided

Conditions

Delirium

Interventions

CogCheck application

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Apr 2017Actual

Completion Date

Apr 2017Actual

First Submitted Date

Mar 4, 2016

First Submission Date that Met QC Criteria

Mar 9, 2016

First Posted Date

Mar 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2018

Last Update Posted Date

Apr 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

334Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CogCheck application	Other	The application is administered once to all study participants.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CogCheck	Score in a self-administered tablet computer-based neuropsychological assessment.	Baseline.

Secondary Outcomes

Measure	Description	Time Frame
Mini-Mental State Examination (MMSE)	Obtained score in MMSE.	Baseline.
Geriatric Depression Scale (GDS)	Obtained score in GDS.	Baseline.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Non-surgical, cognitively healthy volunteers

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolai Goettel, MD	University Hospital, Basel, Switzerland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel		4031	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

No.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003693	Delirium
D000071257	Emergence Delirium

Ancestor Terms

ID	Term
D003221	Confusion
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided