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Development of Customized Health Care Model for Elderly based on Community Care (Effect of oral health care intervention program)

Status Approved

First Submitted Date

2021/02/14
Registered Date

2021/03/02
Last Updated Date

2021/02/19

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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	KCT0005937
Unique Protocol ID	NRF-2020S1A5A2A01042603
Public/Brief Title	Community Care Elderly Oral Health Care
Scientific Title	Development of Customized Health Care Model for Elderly based on Community Care (Effect of oral health care intervention program)
Acronym	CHCM
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 University 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, Korea
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, Korea
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, 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
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-06-25 Actual
Target Number of Participant	60
Primary Completion Date	2021-06-24 , Anticipated
Study Completion Date	2021-06-24 , Anticipated
Name of Study	Dankook University
Recruitment Status	Recruiting
Date of First Enrollment	2020-06-25 ,

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 final goal of this study is to provide basic data to discover a successful community integrated care model through effectiveness verification by applying a community care-based elderly visit oral care intervention program. The specific research goals are as follows. 1) Analysis of the effect of community care-based visiting oral health intervention program on quality of life 2) Development of a customized integrated care model for elderly health management based on community care

Study Summary Information

Lay Summary

● The final goal of this study is to provide basic data to discover a successful community integrated care model through effectiveness verification by applying a community care-based elderly visit oral care intervention program.
   The specific research goals are as follows.
1) Analysis of the effect of community care-based visiting oral health intervention program on quality of life
2) Development of a customized integrated care model for elderly health management based on community care

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	Prevention
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Single
Blinded Subject	Subject, Caregiver
Allocation	Non-RCT
Intervention Type	Behavioral
Intervention Description	* Intervention group: Operation of oral management intervention program (6 weeks) -Once a week for 6 weeks -Conducted for 30 minutes by visiting home -Professional oral hygiene management (Wadanabe brushing) -Tongue brushing -Oral mucosa management -Oral massage and oral gymnastics -Oral health consultation -Individual oral health education necessary for self-care
Number of Arms	3
Arm 1	Arm Label Interverntion Group 1
	Target Number of Participant 20
	Arm Type Experimental
	Arm Description * Operation of oral management intervention program (6 weeks) -Once a week for 6 weeks -Intervention for 30 minutes per day for the elderly subject to community health care -Professional oral hygiene management (Wadanabe brushing) -Tongue brushing -Oral mucosa management -Oral massage and oral gymnastics -Oral health consultation -Individual oral health education necessary for self-care
Arm 2	Arm Label Interverntion Group 2
	Target Number of Participant 20
	Arm Type Active comparator
	Arm Description * Operation of oral management intervention program (6weeks) -Once a week for 6 weeks -Intervention for 30 minutes per day for the elderly in nursing homes -Professional oral hygiene management (Wadanabe brushing) -Tongue brushing -Oral mucosa management -Oral massage and oral gymnastics -Oral health consultation -Individual oral health education necessary for self-care
Arm 3	Arm Label Control Group
	Target Number of Participant 20
	Arm Type No intervention
	Arm Description None

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (K00-K93)Diseases of the digestive system (K11.7)Disturbances of salivary secretion Education of Patients / Xerostomia
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 65Year~90Year
	Description ● Intervention Group 1: Elderly people participating in community health care support projects ● Intervention Group 2: Elderly living in nursing home ● Control group (non-intervention group): Senior citizens living in nursing homes and not participating in community health care projects ● Common: 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 ● Excluding those who gave up participation in the study due to severe discomfort during participation in the study and difficulty in progress
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Oral health behavior
Timepoint	Baseline, 6 weeks
Primary Outcome(s) 2
Outcome	Dental plaque index
Timepoint	Baseline, 6 weeks
Primary Outcome(s) 3
Outcome	The rheological properties of saliva
Timepoint	Baseline, 6 weeks
Primary Outcome(s) 4
Outcome	Oral function test
Timepoint	Baseline, 6 weeks
Primary Outcome(s) 5
Outcome	Tongue index (WTC)
Timepoint	Baseline, 6 weeks
Primary Outcome(s) 6
Outcome	Activities of Daily Living (ADL)
Timepoint	Baseline, 6 weeks
Primary Outcome(s) 7
Outcome	Subjective swallowing ability test
Timepoint	Baseline, 6 weeks
Secondary Outcome(s) 1
Outcome	Mini-Mental State Examination
Timepoint	Baseline
Secondary Outcome(s) 2
Outcome	Oral health status
Timepoint	Baseline, 6 weeks

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. 6
Way of Sharing	To be made available at a later date (jhj@dankook.ac.kr)

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