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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039074
Receipt No. R000044558
Scientific Title Evaluation, practice and construction of support system for oral care of the elderly requiring home-based support and care in the community by cooperation between dentists and nurses
Date of disclosure of the study information 2020/01/08
Last modified on 2020/01/07

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Basic information
Public title Evaluation, practice and construction of support system for oral care of the elderly requiring home-based support and care in the community by cooperation between dentists and nurses
Acronym Oral care of the elderly requiring home-based support and care by cooperation between dentists and nurses
Scientific Title Evaluation, practice and construction of support system for oral care of the elderly requiring home-based support and care in the community by cooperation between dentists and nurses
Scientific Title:Acronym Intervention study on the oral care of the elderly requiring home-based support and care by cooperation between dentists and nurses
Region
Japan

Condition
Condition Aspiration pneumonia
Classification by specialty
Infectious disease Geriatrics Dental medicine
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Dentists conduct a dental checkup for the elderly requiring home-based support and care who use outpatient nursing care services or short-stay nursing care services facilities. Based on the evaluation results, dentists, dental hygienists, nurses, and oral care professionals collaborate to create oral care plans tailored to individual subjects, and provide and guide oral care. We evaluate the effectiveness of these oral care system practice
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation items before and after 3 months of oral care system
(1) The number of general bacteria, Staphylococcus aureus, Streptococcus pneumoniae, and Pseudomonas aeruginosa detected in the oral cavity
(2) Evaluation score of each item of OHAT-J (Oral Health Assessment Tool)
(3) Evaluation (%) of Plaque Control Record (PCR) created by O'Leary et al.
Key secondary outcomes Evaluation items before and after 3 months of oral care system
Implementation status of oral care,Practitioner of oral care, Caregiver's intervention in oral care, Consultation of dental regular checkups

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 (1)Dental examination and evaluation of oral hygiene status by dentist
(2)Guidance by dental hygienist (subjects, nurse, care worker)
(3)Oral care and guidance by nurses and care workers
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) The elderly requiring home-based support and care for those 65 years or older who use outpatient nursing care services or short-stay nursing care services facilities
(2) A person who has given written consent from the person or his / her sponsor regarding participation in this study
Key exclusion criteria Those who are expected to use the facility for less than 3 months.
A person who is judged to be inappropriate as a target by the judgment of the dentist.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Yukiyo
Middle name
Last name Nakagomi
Organization Faculty of Medicine, University of Yamanashi
Division name Department of Fundamental and Clinical Nursing
Zip code 409-3898
Address 1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
TEL 055-273-1111
Email nyukiyo@yamanashi.ac.jp

Public contact
Name of contact person
1st name Fuminori
Middle name
Last name Tanabe
Organization Faculty of Medicine, University of Yamanashi
Division name Department of Fundamental and Clinical Nursing
Zip code 409-3898
Address 1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
TEL 055-273-1111
Homepage URL
Email ftanabe@yamanashi.ac.jp

Sponsor
Institute Faculty of Medicine, University of Yamanashi
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Social Welfare Corporation,
Yamanashi Worker Welfare Association, Kyoritsu Nursing Care Center, Momosono
Public Interest Incorporated Association, Yamanashi Worker Medical Association, Koma Kyoritsu Dental Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Yamanashi, Certified Review Board
Address 1110 Shimokato, Chuo, Yamanashi 409-3898, Japan
Tel 055-273-1111
Email rec-med@yamanashi.ac.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 社会福祉法人 やまなし勤労者福祉共立介護福祉センターももその

Other administrative information
Date of disclosure of the study information
2020 Year 01 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 Enrolling by invitation
Date of protocol fixation
2019 Year 09 Month 26 Day
Date of IRB
2019 Year 09 Month 26 Day
Anticipated trial start date
2019 Year 11 Month 14 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 07 Day
Last modified on
2020 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044558

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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