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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038524
Receipt No. R000043905
Scientific Title Intervention study on the implementation of oral function improvement services by dental hygienists for users of nursing care elderly health facility Watatsumi Day Service
Date of disclosure of the study information 2019/11/08
Last modified on 2019/11/08

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Basic information
Public title Intervention study on the implementation of oral function improvement services by dental hygienists for users of nursing care elderly health facility Watatsumi Day Service
Acronym Intervention study on the implementation of oral function improvement services
Scientific Title Intervention study on the implementation of oral function improvement services by dental hygienists for users of nursing care elderly health facility Watatsumi Day Service
Scientific Title:Acronym Intervention study on the implementation of oral function improvement services
Region
Japan

Condition
Condition None
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate all the facility users and to grasp the current situation, and to provide oral function improvement services to the target persons with the aim of improving oral function.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oral Diadocokinesis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Provision of individual oral function improvement services by dental hygienists
Interventions/Control_2 Provision of overall oral function improvement services by dental hygienists
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
65 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Persons who need support 1 or 2 of the elderly health care facility Watatsumi Day Care users and who have consented to this study
Key exclusion criteria Those who did not obtain consent for this study
People over 100 years old
Target sample size 100

Research contact person
Name of lead principal investigator
1st name MIHO
Middle name
Last name MANABE
Organization Mitoyo General Hospital
Division name Department of Dental Hygiene
Zip code 769-1695
Address 708 Himehama, Toyohama-cho, Kannonji City, Kagawa Prefecture
TEL 0875-52-3366
Email candypop_666@yahoo.co.jp

Public contact
Name of contact person
1st name MIHO
Middle name
Last name MANABE
Organization Mitoyo General Hospital
Division name Department of Dental Hygiene
Zip code 769-1695
Address 708 Himehama, Toyohama-cho, Kannonji City, Kagawa Prefecture
TEL 0875523366
Homepage URL
Email candypop_666@yahoo.co.jp

Sponsor
Institute Mitoyo General Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Mitoyo General Hospital
Address 708 Himehama, Toyohama-cho, Kannonji City, Kagawa Prefecture
Tel 0875-52-3366
Email candypop_666@yahoo.co.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 11 Day
Last follow-up date
2021 Year 11 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 08 Day
Last modified on
2019 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043905

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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