UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048511
Receipt number 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 11:33:49

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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 or person

Institute

Akiyama Hospital

Institute

Department

Personal name



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

Value
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