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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000048511
Receipt No. R000055278
Scientific Title Oral care in hospitalized patients with severe dementia in Japan
Date of disclosure of the study information 2022/08/01
Last modified on 2022/07/29

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Basic information
Public title Oral care in patients with dementia
Acronym dementia and oral care
Scientific Title Oral care in hospitalized patients with severe dementia in Japan
Scientific Title:Acronym Oral care in patients with dementia
Region
Japan

Condition
Condition severe dementia
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study was to evaluate the effect of standardized oral care intervention on the oral hygiene of care-dependent and hospitalized patients with severe dementia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Oral hygiene was assessed using the Eilers Oral Assessment Guide (OAG) between baseline and 3 months post-intervention.
Key secondary outcomes physical status and nutritional status were evaluated using body mass index (BMI) and the Controlling Nutritional Status (CONUT) scale, respectively; and activities of daily living were assessed using the Physical Self-Maintenance Scale (PSMS).

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
Device,equipment
Interventions/Control_1 Massage
A cold stimulator filled with water, similar to a cocktail shaker, was used to massage the skin at the position of the salivary glands (parotid, submandibular, and sublingual glands) in a circular motion for 15 s.
Swallowing training
The patients were instructed to push their foreheads with their hands and observe their navels for 10 s against the force of their hands. This exercise was performed 10 times a day with the help of a caregiver.
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
95 years-old >=
Gender Male and Female
Key inclusion criteria Severe dementia was defined as follows: (1) Mini-Mental State Examination score (MMSE) < 10 points and (2) Eilers Oral Assessment Guide (OAG) score > 13 points.
Key exclusion criteria severity of behavioral and psychological symptoms of dementia (BPSD).
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Hamuro
Organization Akiyama Hospital
Division name Department of Psychiatry
Zip code 8540007
Address 737-1 Meshirocho, Isahaya, Nagasaki
TEL 0957222370
Email ahamuro007@yahoo.co.jp

Public contact
Name of contact person
1st name Atsushi
Middle name
Last name Hamuro
Organization Akiyama Hospital
Division name Department of Psychiatry
Zip code 8540007
Address 737-1 Meshirocho, Isahaya, Nagasaki
TEL 0957222370
Homepage URL
Email ahamuro007@yahoo.co.jp

Sponsor
Institute Akiyama Hospital
Institute
Department

Funding Source
Organization This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Akiyama Hospital
Address 737-1 Meshirocho, Isahaya, Nagasaki
Tel 0957222370 /+81957222370
Email ahamuro007@yahoo.co.jp /ahamuro007@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
2022 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 13
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 Completed
Date of protocol fixation
2021 Year 08 Month 01 Day
Date of IRB
2021 Year 09 Month 01 Day
Anticipated trial start date
2021 Year 09 Month 30 Day
Last follow-up date
2021 Year 12 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 07 Month 29 Day
Last modified on
2022 Year 07 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055278

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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