UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of an educational intervention on oral hygiene and self-care among people with mental illness.
Title of the study (Brief title)	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	Hatsumi Yoshii
Organization	Tohoku University, Graduate School of Medicine
Division name	Health Sciences
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	Hatsumi Yoshii
Organization	Tohoku University, Graduate School of Medicine
Division name	Health Sciences
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 02 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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