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

February 7, 2024 updated by: Jun Young Lee, Seoul National University Hospital
Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-707
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cognitive Improvement software
Usability assessment of cognitive improvement software
Other: Cognitive improvement software
Cognitive improvement software

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Usability: Based on user survey
Time Frame: Single-point evaluation (baseline)
Single-point evaluation (baseline)
Usability: Based on hemodynamic responses
Time Frame: Single-point evaluation (baseline)
Single-point evaluation (baseline)
Changes in Adas-cog
Time Frame: After 12 weeks of system usage
After 12 weeks of system usage
Changes in ADCS-ADL
Time Frame: After 12 weeks of system usage
After 12 weeks of system usage
Changes in self-reported quality of life
Time Frame: After 12 weeks of system usage
After 12 weeks of system usage
Changes in blood biomarker
Time Frame: After 12 weeks of system usage
After 12 weeks of system usage

Other Outcome Measures

Outcome Measure
Time Frame
MMSE
Time Frame: Single-point evaluation (baseline)
Single-point evaluation (baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul National University Boramae Hospital

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2022

Primary Completion (Actual)

March 20, 2023

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

November 21, 2022

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

December 2, 2022

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-2022-48

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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