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Feasibility and Effects of Applying Shoe-attached Location Tracking Devices to Persons Living with Dementia: A Pilot Study

Status Approved

  • First Submitted Date

    2024/01/31

  • Registered Date

    2024/02/29

  • Last Updated Date

    2024/03/25

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number    		 KCT0009211
    Unique Protocol ID IRB No. 2402/001-008
    Public/Brief Title Feasibility and Effects of Applying Shoe-attached Location Tracking Devices to Persons Living with Dementia: A Pilot Study
    Scientific Title Feasibility and Effects of Applying Shoe-attached Location Tracking Devices to Persons Living with Dementia: A Pilot Study
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable

  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number IRB No. 2402/001-008
    Approval Date 2024-01-30
    Institutional Review Board Name Seoul National University Institutional Review Board
    Institutional Review Board Address 1, Gwanak-ro, Gwanak-gu, Seoul
    Institutional Review Board Telephone 02-880-5153
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Yeji Hwang
    Title Assistant Professor
    Telephone +82-2-740-8480
    Affiliation Seoul National University
    Address 103 Daehak-ro, Jongno-gu, Seoul, 03080, Korea
    Contact Person for Public Queries
    Name Yunji Han
    Title Researcher
    Telephone +82-2-740-8480
    Affiliation Seoul National University
    Address 103 Daehak-ro, Jongno-gu, Seoul, 03080, Korea
    Contact Person for Updating Information
    Name Yunji Han
    Title Researcher
    Telephone +82-2-740-8480
    Affiliation Seoul National University
    Address 103 Daehak-ro, Jongno-gu, Seoul, 03080, Korea

  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2024-03-23 Actual
    Target Number of Participant 44
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Seoul National University
    Recruitment Status Recruiting
    Date of First Enrollment 2024-03-23 ,

  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name National Research Foundation
    Organization Type Others
    Project ID RS-2023-00272821

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Seoul National University
    Organization Type University

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    The number of people living with dementia is increasing worldwide, including in South Korea. Wandering is a common behavioral problem among individuals living with dementia. Wandering behavior among community-residing older adults with dementia not only increases the risk of getting lost but also increases caregiver burden and stress among family caregivers. The purpose of this study is to apply shoe-attached location-tracking devices to individuals living with dementia to examine their feasibility and effectiveness for persons living with dementia and their family caregivers. This study is a multi-method study that includes both quantitative and qualitative approaches.

  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose 
     Supportive Care
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Others  
    Intervention Description 
    The research team will attach commercial location-tracking devices (approximately 8 grams) to the participants' own shoes. The participants are expected to wear these trackers for about 2 months. The location data will be accessible exclusively on a designated smartphone owned by the participant's family caregiver.
    Number of Arms 1
    Arm 1

    Arm Label

    Intervention Group Using Location-tracking Device

    Target Number of Participant

    44

    Arm Type

    Experimental

    Arm Description

    The research team will attach commercial location-tracking devices (approximately 8 grams) to the shoes of the intervention group participants. The participants are expected to wear these trackers for about 2 months.

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F06.7)Mild cognitive disorder 

    cognitive dysfunction; dementia
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    [Participants with Cognitive Impairment]
(1) Individuals diagnosed with mild cognitive impairment
(2) Individuals residing in the community
(3) Individuals who have a family caregiver living with them or nearby
(4) Individuals who are able to move independently
(5) Individuals who are capable of going out
(6) Individuals who understand the purpose of this study and have agreed to participate

[Family Caregivers]
(1) Individuals aged 18 and over
(2) Individuals who are family members of the participant with cognitive impairment
(3) Individuals who possess a smartphone
(4) Individuals who understand the purpose of this study and have agreed to participate
    Exclusion Criteria 
    Individuals who have not gone out alone in the last 2 months will be excluded from the study. Participants with cognitive impairment who refuse to attach location-tracking device to their own shoes, and family caregivers who refuse to install an app on their smartphones that syncs with the location tracker, cannot participate in this study.
    Healthy Volunteers No

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome 
    Anxiety
    Timepoint 
    Pretest, Posttest
    Secondary Outcome(s) 1
    Outcome 
    Caregiver burden
    Timepoint 
    Pretest, Posttest

  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No

  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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