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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000033230
Receipt No. R000037878
Scientific Title Effects of an educational intervention on oral hygiene and self-care among people with mental illness.
Date of disclosure of the study information 2018/07/02
Last modified on 2018/07/02

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Basic information
Public title Effects of an educational intervention on oral hygiene and self-care among people with mental illness.
Acronym Effects of an educational intervention on oral hygiene and self-care among people with mental illness.
Scientific Title Effects of an educational intervention on oral hygiene and self-care among people with mental illness.
Scientific Title:Acronym Effects of an educational intervention on oral hygiene and self-care among people with mental illness.
Region
Japan

Condition
Condition Mental illness
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, to establish an effective oral health support system for patients, we conducted a survey of individuals attending psychiatric day care centers in Japan to examine oral self-care practices and personal preferences centering on between-meal snacks. We also developed an oral hygiene educational program and investigated its efficacy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We developed an oral hygiene educational program and investigated its efficacy.
Key secondary outcomes

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 We first conducted a survey of knowledge and self-care related to oral hygiene. Second, all respondents viewed an educational presentation on oral hygiene. Third, after 1 week, the respondents again answered questions on knowledge and self-care related to oral hygiene. Fourth, after 1 month, the respondents answered the same questions. Fifth, after 3 months, the respondents again answered the same questions. Sixth, the respondents answered the questions again after 6 months. Finally, the respondents answered the questions again after 1 year.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 20 years of age or older.
Members of psychiatric day care center.
The patient is in stable condition.
Key exclusion criteria Other than that.
Mental retardation.
Dementia.
Target sample size 390

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hatsumi Yoshii
Organization Tohoku University, Graduate School of Medicine
Division name Health Sciences
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL 0227177954
Email hatsumi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hatsumi Yoshii
Organization Tohoku University, Graduate School of Medicine
Division name Health Sciences
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8575, Japan
TEL 0227177954
Homepage URL
Email hatsumi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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
Address
Tel
Email

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
2018 Year 07 Month 02 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
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 Main results already published
Date of protocol fixation
2014 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 02 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037878

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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