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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025672
Receipt No. R000029533
Scientific Title Wasure-NAVI-to for a better dementia and MCI patient care.
Date of disclosure of the study information 2017/01/16
Last modified on 2018/01/16

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Basic information
Public title Wasure-NAVI-to for a better dementia and MCI patient care.
Acronym Wasure-Navi-to
Scientific Title Wasure-NAVI-to for a better dementia and MCI patient care.
Scientific Title:Acronym Wasure-Navi-to
Region
Japan

Condition
Condition mild cognitive impairment, dementia
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 People with dementia or mild cognitive impairment (MCI) need personalized care, especially because their symptoms arise from their past experience and current relationships with their families and friends. In Japanese outpatient clinic settings, sessions for each patient tend to be very brief owing to the large number of patients visiting hospitals; quite often, sessions are as short as three minutes and can only be held once every three months. Unlike other diseases that physicians deal with, this is not tolerable at all, because it is obvious that under these circumstances it is almost impossible to obtain personal information or give personal advice. Professionals involved in dementia care range from physicians to community volunteers; sharing patient background information or current status among those individuals is extremely important. However, in addition to the previously mentioned limitations, person-to-person or community based approaches are becoming increasingly difficult in urban settings. Thus, better dementia care requires better communication tools that also assure secure information exchange.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Research satisfaction Survey
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Usage of ICT tablet
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with diagnosis of mild cognitive impairment or dementia and their primary caregiver.
Key exclusion criteria subjects without consent
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Iwata
Organization The University of Tokyo Hospital
Division name Department of Neurology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo
TEL 03-5800-8672
Email iwata@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Iwata
Organization The University of Tokyo Hospital
Division name Department of Neurology
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo
TEL 03-5800-8672
Homepage URL
Email iwata@m.u-tokyo.ac.jp

Sponsor
Institute Japan Science and Technology Agency
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
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
2017 Year 01 Month 16 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
2016 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 05 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
2017 Year 01 Month 14 Day
Last modified on
2018 Year 01 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029533

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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