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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027478
Receipt No. R000031478
Scientific Title Study on the effect of oral health related educational program among caregivers in nursing home
Date of disclosure of the study information 2017/06/02
Last modified on 2017/11/23

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Basic information
Public title Study on the effect of oral health related educational program among caregivers in nursing home
Acronym Study on the effect of oral health related educational program among caregivers
Scientific Title Study on the effect of oral health related educational program among caregivers in nursing home
Scientific Title:Acronym Study on the effect of oral health related educational program among caregivers
Region
Japan

Condition
Condition None
Classification by specialty
Dental medicine Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study are to influence of oral health related educational program on caregiver burden.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes original questionnaire
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Oral health related educational program (High self-efficacy)
Interventions/Control_2 Oral health related educational program (Low self-efficacy)
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
120 years-old >
Gender Male and Female
Key inclusion criteria caregiver
Key exclusion criteria dental staff
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yuhei Matsuda
Organization Kyushu Dental University
Division name Oral health sciences
Zip code
Address 2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka
TEL 0932853109
Email r15matsuda@fa.kyu-dent.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yuhei Matsuda
Organization Kyushu Dental University
Division name Oral health sciences
Zip code
Address 2-6-1, Manazuru, Kokura-kita, Kitakyushu, Fukuoka
TEL 0932853109
Homepage URL
Email r15matsuda@fa.kyu-dent.ac.jp

Sponsor
Institute Kyushu Dental University
Institute
Department

Funding Source
Organization None
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
2017 Year 06 Month 02 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Completed
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 02 Day
Last follow-up date
2017 Year 11 Month 01 Day
Date of closure to data entry
2017 Year 11 Month 23 Day
Date trial data considered complete
2017 Year 11 Month 23 Day
Date analysis concluded
2017 Year 11 Month 27 Day

Other
Other related information

Management information
Registered date
2017 Year 05 Month 24 Day
Last modified on
2017 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031478

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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