UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Wasure-NAVI-to for a better dementia and MCI patient care.
Title of the study (Brief title)	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	Atsushi Iwata
Organization	The University of Tokyo Hospital
Division name	Department of Neurology
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	Atsushi Iwata
Organization	The University of Tokyo Hospital
Division name	Department of Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029533