Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study
1 other identifier
observational
30
1 country
1
Brief Summary
Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2022
CompletedStudy Start
First participant enrolled
November 21, 2022
CompletedFirst Posted
Study publicly available on registry
December 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedFebruary 9, 2024
February 1, 2024
4 months
November 21, 2022
February 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Usability: Based on scenarios
Single-point evaluation (baseline)
Secondary Outcomes (6)
Usability: Based on user survey
Single-point evaluation (baseline)
Usability: Based on hemodynamic responses
Single-point evaluation (baseline)
Changes in Adas-cog
After 12 weeks of system usage
Changes in ADCS-ADL
After 12 weeks of system usage
Changes in self-reported quality of life
After 12 weeks of system usage
- +1 more secondary outcomes
Other Outcomes (1)
MMSE
Single-point evaluation (baseline)
Study Arms (1)
Cognitive Improvement software
Usability assessment of cognitive improvement software
Interventions
Eligibility Criteria
Cognitively Impaired patients aged 55 to 85, based in South Korea.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun-Young Lee, M.D., Ph.D.
Department of Psychiatry, Seoul National University College of Medicine, Department of Psychiatry, SMG-SNU Boramae Medical Center
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 21, 2022
First Posted
December 2, 2022
Study Start
November 21, 2022
Primary Completion
March 20, 2023
Study Completion
March 31, 2024
Last Updated
February 9, 2024
Record last verified: 2024-02