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Development of Customized Health Care Model for Elderly based on Community Care

Status Approved

  • First Submitted Date

    2021/02/19

  • Registered Date

    2021/03/11

  • Last Updated Date

    2021/03/04

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    		 KCT0005990
    Unique Protocol ID DKU 2020-05-014-001
    Public/Brief Title Quality of life related to oral health in the elderly
    Scientific Title Development of Customized Health Care Model for Elderly based on Community Care
    Acronym CHC
    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 DKU 2020-05-014-001
    Approval Date 2020-06-25
    Institutional Review Board Name Dankook universoty Institutional Review Board
    Institutional Review Board Address #433, 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do
    Institutional Review Board Telephone 041-550-1058
    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 Jong-Hwa Jang
    Title professor
    Telephone +82-41-550-1495
    Affiliation Dankook University
    Address 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam, 31116
    Contact Person for Public Queries
    Name Jong-Hwa Jang
    Title professor
    Telephone +82-41-550-1495
    Affiliation Dankook University
    Address 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam, 31116
    Contact Person for Updating Information
    Name Jong-Hwa Jang
    Title professor
    Telephone +82-41-550-1495
    Affiliation Dankook University
    Address 119, Dandae-ro, Dongnam-gu, Cheonan-si, Chungnam, 31116

  • 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 2020-06-26 Actual
    Target Number of Participant 100
    Primary Completion Date 2021-06-25 , Anticipated
    Study Completion Date 2021-06-25 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Dankook University
    Recruitment Status Recruiting
    Date of First Enrollment 2020-06-26 ,

  • 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 Government
    Project ID NRF-2020S1A5A2A01042

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Dankook University
    Organization Type University

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    -The key to health promotion is to lead to desirable health behavior by improving health-related lifestyle habits.
-Changes in lifestyle habits have a profound impact on cognitive, social, and environmental obstacles.
-In this study, the determinants of the quality of life of the elderly subject to the leading community care project currently being carried out as a state-run project are identified, and furthermore, oral health behavior of the elderly is applied by applying the latest theory of health behavior, the Intergrated Behavioral Model (IBM) The purpose of this study is to analyze the predictive factors of quality of life.

  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 100
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Oral frailty group

    Cohort/Group Description

    - (Oral frailty group) Seniors who are eligible for visiting oral health care based on the Cheonan City Community Care Project

- (Measurement method) Preliminary survey, 6-month survey, and 12-month survey using questionnaire, interview and observation method

-(Measurement Variables) Oral frailty, Activities of Daily Living, Xerostomia, Geriatric oral health assessment index, Health-related quality of life, Oral health status, Oral muscle function evaluation, Rheological characteristics of saliva, Mini-Mental State Examination, General characteristics (age, gender, economic level, educational background, family relations, smoking status, experience in oral health education, etc.)
    Biospecimen
    Collection & Archiving    		 
    : DNA Collect & Archive: Sample without DNA
    Biospecimen Description 
    saliva

  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description 
    Among those who are eligible for the community care program, the elderly who are eligible for the visiting oral health care program
    Sampling Method 
    simple random sampling
    Condition(s)/Problem(s) * (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC 
       (R54)Senility 

    Frailty Elderly
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    65Year~No Limit

    Description

    -Elderly people who participate in community care leading projects
-A person who voluntarily decides to participate and agrees in writing to observe the precautions after hearing and understanding detailed explanations on participation in the research
    Exclusion Criteria 
    -Those who have severe dry mouth and have difficulty collecting saliva samples
 -A person who gave up participation in the study halfway due to difficulty in progress due to severe discomfort during participation
 -Elderly people with low cognitive function who cannot respond to questionnaires and interviews
    Healthy Volunteers Yes

  • 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 
    Oral frailty
    Timepoint 
    Baseline, after 6 months, after 12 months
    Primary Outcome(s) 2
    Outcome 
    Activities of Daily Living
    Timepoint 
    Baseline, after 12 months
    Primary Outcome(s) 3
    Outcome 
    Perceived xerostomia
    Timepoint 
    Baseline, after 6 months, after 12 months
    Primary Outcome(s) 4
    Outcome 
    Geriatric Oral Health Assessment Index
    Timepoint 
    Baseline, after 12 months
    Primary Outcome(s) 5
    Outcome 
    Health-related Quality of Life
    Timepoint 
    Baseline, after 12 months
    Primary Outcome(s) 6
    Outcome 
    Oral health status (the number of existing teeth, whether or not dentures are worn, dental plaque index, tongue index, etc.)
    Timepoint 
    Baseline, after 6 months, after 12 months
    Primary Outcome(s) 7
    Outcome 
    Oral health behavior (number of brushing, brushing method, regular oral examination, etc.)
    Timepoint 
    Baseline, after 6 months, after 12 months
    Primary Outcome(s) 8
    Outcome 
    Oral muscle function evaluation
    Timepoint 
    Baseline, after 6 months, after 12 months
    Primary Outcome(s) 9
    Outcome 
    Rheological properties of saliva (flow rate of unstimulated saliva, saliva amylase)
    Timepoint 
    Baseline, after 6 months, after 12 months
    Primary Outcome(s) 10
    Outcome 
    Social support
    Timepoint 
    Baseline, after 12 months
    Primary Outcome(s) 11
    Outcome 
    Self-efficacy related to oral health
    Timepoint 
    Baseline, after 12 months
    Secondary Outcome(s) 1
    Outcome 
    General characteristics (age, gender, economic level, educational background, family relations, smoking status, experience in oral health education)
    Timepoint 
    Baseline, after 12 months
    Secondary Outcome(s) 2
    Outcome 
    Mini–Mental State Examination
    Timepoint 
    Baseline, after 12 months

  • 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 Yes
    Time of Sharing 2022. 12
    Way of Sharing To be made available at a later date
    (jhj@dankook.ac.kr)
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