UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025672 |
|---|---|
| Receipt number | 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 19:20:07 |
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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
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
iwata@m.u-tokyo.ac.jp
Sponsor or person
Institute
Japan Science and Technology Agency
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
