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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024119
Receipt No. R000027764
Scientific Title Deployment of oral function and nutrition care of low vision elderly by medical welfare cooperation
Date of disclosure of the study information 2016/11/01
Last modified on 2017/03/23

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Basic information
Public title Deployment of oral function and nutrition care of low vision elderly by medical welfare cooperation
Acronym Deployment of oral function and nutrition care of low vision elderly by medical welfare cooperation
Scientific Title Deployment of oral function and nutrition care of low vision elderly by medical welfare cooperation
Scientific Title:Acronym Deployment of oral function and nutrition care of low vision elderly by medical welfare cooperation
Region
Japan

Condition
Condition low vision
Classification by specialty
Ophthalmology Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 From the point of view of the medical and welfare cooperation, to elucidate the reality of low vision elderly oral dysfunction and nutrition situation, reveal the life issues related to it. To build the evidence of dental critical low vision elderly care of the way in cooperation with the welfare on it.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. life task investigation
2.oral function evaluation
3.nutritional status evaluation
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 Self control
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 For the low vision elderly and healthy elderly, life challenges, oral function, performs a cross-sectional study and evaluation on nutritional status, reveal the details of the actual situation. As a result from the low vision life challenges, oral function, to elucidate the relationship of nutritional status.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Healthy elderly about 50 people
2)Low vision elderly about 50 people
Key exclusion criteria There is a systemic disease, such as dementia, a subject that can not be answered oral questions are excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name keiko endo
Organization tokyo medical and dental university
Division name Section of Oral Health Care Section for Community and Welfare, Graduate School
Zip code
Address 1-5-45 YUshima Bunkyo-ku Tokyo
TEL 03-5803-4969
Email k-enohcw@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name keiko endo
Organization tokyo medical and dental university
Division name Section for Community and Welfare, Graduate School
Zip code
Address 1-5-45 YUshima Bunkyo-ku Tokyo
TEL 03-5803-4969
Homepage URL
Email k-enohcw@tmd.ac.jp

Sponsor
Institute tokyo medical end dental university
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 11 Month 01 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 No longer recruiting
Date of protocol fixation
2016 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 15 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 10 Month 31 Day
Date trial data considered complete
2018 Year 12 Month 31 Day
Date analysis concluded
2019 Year 01 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 21 Day
Last modified on
2017 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027764

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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