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Cognitive Training for Digital Biomarkers

Primary Purpose

Cognitive Decline, Healthy Aging

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smartphone-based cognitive training
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cognitive Decline focused on measuring digital biomarker

Eligibility Criteria

60 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: At least 60 years of age, Can communicate in Chinese (Taiwanese) Bring your own mobile device with Internet access. Can act alone without physical impairment;full score of basic activities of daily living scale and instrumental activities of daily living scale. Exclusion Criteria: Dementia diagnosed by a physician and in compliance with ICD-10 Physician diagnosed with significant mental illness or communication impairment Participated in other cognitive training studies within the past year Medical conditions associated with rapid functional and cognitive decline Severe visual impairment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Cognitive training

    Usual care

    Arm Description

    Smartphone-based cognitive training

    No intervention

    Outcomes

    Primary Outcome Measures

    digital biomarker
    wearable device of stress and sleep, EEG power in alpha band, Delta and Theta frequency-bands

    Secondary Outcome Measures

    Montreal Cognitive Assessment(MoCA)
    The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool designed to identify mild cognitive impairment, providing a quick assessment of different cognitive domains including memory, attention, language, and executive functions. It is widely utilized in clinical and research settings.The MoCA is scored out of a maximum of 30 points. A score of 26 and above is generally considered to be normal, although the specific cutoff can depend on the individual's age, educational level, and other demographic factors.
    Digit Span(DS)
    Digit Span (DS) is a common test used in neuropsychological assessments to measure working memory, attention, and concentration. Each correctly repeated sequence yields one point. There are typically 16 items for the Forward Digit Span. The Backward Digit Span also has 16 items.
    Digit Vigilance Test(DVT)
    The Digit Vigilance Test (DVT) is a psychological assessment tool used to measure attention and concentration, mainly focused on visual scanning and processing speed. The number of correct identifications and the time taken to complete the task are typically measured.
    Computerized version of Wisconsin Card Sort Test (WCST)
    The Wisconsin Card Sorting Test (WCST) is a well-established neuropsychological test widely used to assess executive functions, mainly focusing on abstract reasoning and the ability to shift cognitive strategies in response to changing environmental contingencies (i.e., set-shifting or cognitive flexibility). The computerized version of the WCST allows for efficient, standardized administration and scoring, often reducing examiner bias and error.
    Stroop color-word test (SCWT)
    The Stroop Color-Word Test (SCWT) evaluates cognitive processing speed, selective attention, and cognitive flexibility, which are aspects of executive functioning. It's particularly notable for its ability to detect cognitive interference and inhibition control.Scores are typically based on:Correct Responses, Time Taken, Error Rate and Interference Score.

    Full Information

    First Posted
    August 16, 2023
    Last Updated
    October 15, 2023
    Sponsor
    Taipei Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06090942
    Brief Title
    Cognitive Training for Digital Biomarkers
    Official Title
    The Effectiveness of Cognitive Training for Digital Biomarkers: Evidence From the Urban and Rural Area
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 20, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2024 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Taipei Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to conduct cognitive training for digital biomarkers among older adults.
    Detailed Description
    The prevalence of dementia in rural areas is higher than in urban areas. However, the resource and research input on cognitive training for rural older adults still needs improvement. There is also no solution for preventing or early detection of dementia in rural areas. Unlike biomarkers that require invasive detection, digital biomarkers have been advocated in recent years for early disease prediction. However, there are still few studies on the effectiveness of digital biomarkers in evaluating cognitive function in the elderly. In addition, although previous studies have confirmed that cognitive training can be effective for older adults, it is difficult for the elderly in rural areas to obtain these cognitive-promoting resources due to distance. Moreover, the autonomy and right of choice of older adults are the keys to the success of their health behavior change.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Decline, Healthy Aging
    Keywords
    digital biomarker

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cognitive training
    Arm Type
    Experimental
    Arm Description
    Smartphone-based cognitive training
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Other
    Intervention Name(s)
    Smartphone-based cognitive training
    Intervention Description
    Smartphone-based cognitive training
    Primary Outcome Measure Information:
    Title
    digital biomarker
    Description
    wearable device of stress and sleep, EEG power in alpha band, Delta and Theta frequency-bands
    Time Frame
    pretest, immediate post test, 3 month follow-up, 6 month follow-up
    Secondary Outcome Measure Information:
    Title
    Montreal Cognitive Assessment(MoCA)
    Description
    The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool designed to identify mild cognitive impairment, providing a quick assessment of different cognitive domains including memory, attention, language, and executive functions. It is widely utilized in clinical and research settings.The MoCA is scored out of a maximum of 30 points. A score of 26 and above is generally considered to be normal, although the specific cutoff can depend on the individual's age, educational level, and other demographic factors.
    Time Frame
    pretest, immediate post test, 3 month follow-up, 6 month follow-up
    Title
    Digit Span(DS)
    Description
    Digit Span (DS) is a common test used in neuropsychological assessments to measure working memory, attention, and concentration. Each correctly repeated sequence yields one point. There are typically 16 items for the Forward Digit Span. The Backward Digit Span also has 16 items.
    Time Frame
    pretest, immediate post test, 3 month follow-up, 6 month follow-up
    Title
    Digit Vigilance Test(DVT)
    Description
    The Digit Vigilance Test (DVT) is a psychological assessment tool used to measure attention and concentration, mainly focused on visual scanning and processing speed. The number of correct identifications and the time taken to complete the task are typically measured.
    Time Frame
    pretest, immediate post test, 3 month follow-up, 6 month follow-up
    Title
    Computerized version of Wisconsin Card Sort Test (WCST)
    Description
    The Wisconsin Card Sorting Test (WCST) is a well-established neuropsychological test widely used to assess executive functions, mainly focusing on abstract reasoning and the ability to shift cognitive strategies in response to changing environmental contingencies (i.e., set-shifting or cognitive flexibility). The computerized version of the WCST allows for efficient, standardized administration and scoring, often reducing examiner bias and error.
    Time Frame
    pretest, immediate post test, 3 month follow-up, 6 month follow-up
    Title
    Stroop color-word test (SCWT)
    Description
    The Stroop Color-Word Test (SCWT) evaluates cognitive processing speed, selective attention, and cognitive flexibility, which are aspects of executive functioning. It's particularly notable for its ability to detect cognitive interference and inhibition control.Scores are typically based on:Correct Responses, Time Taken, Error Rate and Interference Score.
    Time Frame
    pretest, immediate post test, 3 month follow-up, 6 month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: At least 60 years of age, Can communicate in Chinese (Taiwanese) Bring your own mobile device with Internet access. Can act alone without physical impairment;full score of basic activities of daily living scale and instrumental activities of daily living scale. Exclusion Criteria: Dementia diagnosed by a physician and in compliance with ICD-10 Physician diagnosed with significant mental illness or communication impairment Participated in other cognitive training studies within the past year Medical conditions associated with rapid functional and cognitive decline Severe visual impairment

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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