UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024119 |
|---|---|
| Receipt number | 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 12:36:39 |
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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
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
k-enohcw@tmd.ac.jp
Sponsor or person
Institute
tokyo medical end dental university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027764
