Usability of Cognitive Improvement Software in Cognitivel... | NCT05634161

Studies
Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study

NCT05634161

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Feb 9, 2024Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Mild Cognitive Impairment

Interventions

Cognitive improvement software

Countries

South Korea

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

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 21, 2022Actual

Primary Completion Date

Mar 20, 2023Actual

Completion Date

Mar 31, 2024Estimated

First Submitted Date

Nov 21, 2022

First Submission Date that Met QC Criteria

Nov 21, 2022

First Posted Date

Dec 2, 2022Actual

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

Feb 7, 2024

Last Update Posted Date

Feb 9, 2024Actual

Name	Class
Seoul National University Boramae Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.

Detailed Description

Not provided

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive Improvement software		Usability assessment of cognitive improvement software	Other: Cognitive improvement software

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cognitive improvement software	Other	Cognitive improvement software	Cognitive Improvement software

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Usability: Based on scenarios		Single-point evaluation (baseline)

Secondary Outcomes

Measure	Description	Time Frame
Usability: Based on user survey		Single-point evaluation (baseline)
Usability: Based on hemodynamic responses		Single-point evaluation (baseline)
Changes in Adas-cog

Other Outcomes

Measure	Description	Time Frame
MMSE		Single-point evaluation (baseline)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and Female patients, 55~85 years
Adequate vision, hearing and speaking for neuropsychological testing
No difficulty in using mobile application using smartphone
Patients with subjective memory complaints, confirmed by informants
Cognitive impairment of SD 1 or greater from the age-adjusted normal range in Memory domain in CERAD-NP battery
Global CDR 0.5 ~ 1
Korean speaker
Have an identified trial partner
All subjects signed written consent

Exclusion Criteria:

Those unable to provide consent
History of transient ischemic attack, stroke, brain tumor
History of diagnosis of major depression
Symptoms that may interfere with the subject's testing procedure
Cerebral hemorrhage
Central nervous system infections
Prohibited concomitant medication
Known or suspected history of drug or alcohol abuse

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Cognitively Impaired patients aged 55 to 85, based in South Korea.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jun-Young Lee, M.D., Ph.D.	Department of Psychiatry, Seoul National University College of Medicine, Department of Psychiatry, SMG-SNU Boramae Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul Metropolitan Government Seoul National University Boramae Medical Center		Seoul		156-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided