UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033230 |
|---|---|
| Receipt number | 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 08:22:52 |
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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
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
hatsumi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037878
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
