UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037209 |
|---|---|
| Receipt number | R000042425 |
| Scientific Title | Dementia prevention to elderly people using AI |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2021/06/29 14:33:11 |
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Basic information
Public title
Dementia prevention to elderly people using AI
Acronym
Dementia prevention to elderly people using AI
Scientific Title
Dementia prevention to elderly people using AI
Scientific Title:Acronym
Dementia prevention with AI
Region
| Japan |
Condition
Condition
Mild cognitive impairment
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prevent dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function
Psychometric scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
1.Brain training group by AI6 months each
Interventions/Control_2
2.Non intervention group
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
65 years of age or older
Key exclusion criteria
Person without consent of research
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Sawami |
Organization
Nara Medical University
Division name
Gerontological nursing
Zip code
0744-22-3051
Address
840 Shijo, Kashihara, Nara, Japan
TEL
0744-22-3051
sawami@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazue |
| Middle name | |
| Last name | Sawami |
Organization
Nara Medical University
Division name
Gerontological nursing
Zip code
634-8521
Address
840 Shijo, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
sawami@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
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
Ethics Review Board of Nara Medical University of Medical
Address
840 Shijo, Kashihara, Nara, Japan
Tel
0744-22-3051
ino_rinri@naramed-u.ac.jp
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
| 2019 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
https://nx.ct-portal.com/shinseis/detail?id=342105
Publication of results
Published
Result
URL related to results and publications
https://mhlw-grants.niph.go.jp/node/147792
Number of participants that the trial has enrolled
200
Results
Visiting homes of elderly people who had difficulty going out and interventions using AI showed significant improvement in cognitive and psychological test results.
Results date posted
| 2020 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 02 | Month | 08 | Day |
Baseline Characteristics
Elderly people living alone
Participant flow
The application form was distributed in the district and a briefing session was held.
The consent form was submitted and registered.
Adverse events
None
Outcome measures
Cognitive Test
Psychological scale
Interview
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 06 | Month | 28 | Day |
Last modified on
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042425
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/06/29 | 02 様式A2 認知症_澤見一枝（H30-認知症-一般-003）.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/06/29 | 2020003A-sokatsu.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/06/29 | 202017002B-sougou.pdf |
Single case data URL
Value
https://center6.umin.ac.jp/ice/42425
