Records View
홈 아이콘 이미지
Search
Search
Search

Effect of Digital Reminiscence Therapy using App in Persons with Dementia

Status Approved

  • First Submitted Date

    2018/10/26

  • Registered Date

    2019/01/24

  • Last Updated Date

    2023/01/05

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    		 KCT0003446
    Unique Protocol ID NRF-2018R1D1A1B07042203
    Public/Brief Title Effect of Digital Reminiscence Therapy using App in Persons with Dementia
    Scientific Title Effect of Digital Reminiscence Therapy using App in Persons with Dementia
    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 FEUIRB-180531-01-2
    Approval Date 2018-06-04
    Institutional Review Board Name Institutional Review Board of KDU
    Institutional Review Board Address 76-32, Daehak-gil, Gamgok-myeon, Eumseong-gun, Chungcheongbuk-do
    Institutional Review Board Telephone 043-880-3220
    Data Monitoring Committee

  • 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 Kyongok Park
    Title assistant professor
    Telephone +82-33-760-8649
    Affiliation Gangneung-Wonju National University
    Address 150, Namwon-ro, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of Korea
    Contact Person for Public Queries
    Name SeolHwa Moon
    Title part-time instructor
    Telephone +82-2-2220-4711
    Affiliation Hanyang University
    Address 222, Wangsimni-ro, Seongdong-gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name Kyongok Park
    Title assistant professor
    Telephone +82-33-760-8649
    Affiliation Gangneung-Wonju National University
    Address 150, Namwon-ro, Heungeop-myeon, Wonju-si, Gangwon-do, Republic of 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 Multi-center Number of center : 9
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2019-02-18 Actual
    Target Number of Participant 50
    Primary Completion Date 2019-06-28 , Actual
    Study Completion Date 2019-06-28 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Wonju Senior Welfare Center
    Recruitment Status Completed
    Date of First Enrollment 2019-02-18 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Myeong Ryun Older Person Welfare Center
    Recruitment Status Completed
    Date of First Enrollment 2019-02-18 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Chung Dam Senior Center
    Recruitment Status Completed
    Date of First Enrollment 2019-03-04 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Eunchon Daycare Center
    Recruitment Status Completed
    Date of First Enrollment 2019-03-04 ,
    Recruitment Status by Participating Study Site 5
    Name of Study Wonju Caritas Community Service Center
    Recruitment Status Completed
    Date of First Enrollment 2019-03-04 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Neul Daycare Center
    Recruitment Status Completed
    Date of First Enrollment 2019-03-04 ,
    Recruitment Status by Participating Study Site 7
    Name of Study Love Nursing Day Care Center
    Recruitment Status Completed
    Date of First Enrollment 2019-03-18 ,
    Recruitment Status by Participating Study Site 8
    Name of Study Jecheon Hyomaeul Senior Daycare Center
    Recruitment Status Completed
    Date of First Enrollment 2019-04-01 ,
    Recruitment Status by Participating Study Site 9
    Name of Study Dansung Daycare Center
    Recruitment Status Completed
    Date of First Enrollment 2019-04-29 ,

  • 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 2018R1D1A1B07042203

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Gangneung-Wonju National University
    Organization Type University

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    Dementia is the 9th most burdensome illness globally. The development of technology such as smart phone apps, robotics, wireless motion sensors and a GPS location system is to improve the quality of life or to assist dementia patients in the activities of daily living (ADL). Therefore, this study aim to develop the digital reminiscence program using app in persons with dementia and testify the feasibility the program. Eventually the interventions using innovative technology such as digital reminiscence program using App will contribute to improve the quality of life in persons with dementia.

  • 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 
    Others
    (nonpharmacological therapy)
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Behavioral  
    Intervention Description 
    In this study, the participants will be provided with app-based reminiscence therapy. In order to provide effective reminiscence therapy for individual participants, we will try to understand the past experiences and preferences of the older adults through the interview with their family caregiver.  We will collect participants` favorite photographs and video materials. The digital Reminiscence therapy will be provided as face to face in intervention between participants and researcher. The program will provide twice a week for 4weeks(a total of 8 times). Participants belong to intervention group will join the with digital reminiscence therapy using app and the participants belong to control group will be provided with a traditional recall therapy program (talking about participant of life).
    Number of Arms 2
    Arm 1

    Arm Label

    life review group

    Target Number of Participant

    25

    Arm Type

    Active comparator

    Arm Description

    Based on the information through the interview with the family caregiver, we will select the theme which will be composed of traditional recall therapy. The participants will join the program talking with the researcher about the participant’s past experience. The program will be conducted twice a week for 4weeks (a total of 8 times).
    Arm 2

    Arm Label

    app-based reminiscence therapy group

    Target Number of Participant

    25

    Arm Type

    Experimental

    Arm Description

    In this study, the participants will be provided with app-based reminiscence therapy. In order to provide effective reminiscence therapy for individual participants, we will try to understand the past experiences and preferences of the older adults through the interview with their family caregiver.  We will collect participants` favorite photographs and video materials. The digital reminiscence therapy will be provided as face to face in intervention between participants and researcher. The program will provide twice a week for 4weeks(a total of 8 times). Participants belong to intervention group will join the with digital reminiscence therapy using app and the participants belong to control group will be provided with a traditional recall therapy program (talking about participant of life).

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F03)Unspecified dementia 

    dementia
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    65Year~No Limit

    Description

    1)	Female ≥ 65 
2)	Diagnosed dementia ( 9< MMSE <20)
3)	No impairment of hearing or vision.
4)	Patients who were registered day care center for more than a month.
    Exclusion Criteria 
    1) Patients who has changed in taking medeciation during intervention period.
2) Patients with psychiatric disease.
    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 
    Quality of life: Korean version of Quality of Life-Alzheimer's Disease(KQOL-AD)
    Timepoint 
    base line,  post intervention1 , post intervention 2 (post 2weeks)
    Primary Outcome(s) 2
    Outcome 
    behavioral and psychological symptoms of dementia: Korean Neuropsychiatric Inventory (K-NPI)
    Timepoint 
    base line,  post intervention1 , post intervention 2 (post 2weeks)
    Primary Outcome(s) 3
    Outcome 
    Cognitive function: Mini-Mental Status Examination for Dementia Screening (MMSE-DS)
    Timepoint 
    base line,  post intervention1 , post intervention 2 (post 2weeks)
    Primary Outcome(s) 4
    Outcome 
    depression: Korean version of The Cornell Scale for Depression in Dementia(K-CSDD)
    Timepoint 
    base line,  post intervention1 , post intervention 2 (post 2weeks)
    Primary Outcome(s) 5
    Outcome 
    Emotion: Video Coding – Incorporating Observed Emotion (VC-IOE)(observation of the degree of change in facial emotional response, verbal engagement, engagement, agitation)
    Timepoint 
    base line,  post intervention1 , post intervention 2 (post 2weeks)
    Secondary Outcome(s) 1
    Outcome 
    care burden of caregiver: Korean version of Zarit Burden Interview(K-ZBI)
    Timepoint 
    base line,  post intervention1 (4week), post intervention 2 (6week)

  • 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
Move list page Move to top
화면 최상단으로 이동

TOP

BOTTOM

화면 최하단으로 이동