UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Deployment of oral function and nutrition care of low vision elderly by medical welfare cooperation
Title of the study (Brief title)	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	keiko endo
Organization	tokyo medical and dental university
Division name	Section of Oral Health Care Section for Community and Welfare, Graduate School
Address	1-5-45 YUshima Bunkyo-ku Tokyo
TEL	03-5803-4969
Email	k-enohcw@tmd.ac.jp

Public contact
Name of contact person	keiko endo
Organization	tokyo medical and dental university
Division name	Section for Community and Welfare, Graduate School
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 12 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027764