UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052254 |
|---|---|
| Receipt number | R000059649 |
| Scientific Title | Practical Validation of a Sensitive AI Robot to Assist Elderly People with Mild Dementia Living Alone |
| Date of disclosure of the study information | 2023/09/20 |
| Last modified on | 2023/09/20 14:00:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Practical Validation of a Sensitive AI Robot to Assist Elderly People with Mild Dementia Living Alone
Acronym
Practical Validation of a Sensitive AI Robot to Assist Elderly People with Mild Dementia Living Alone
Scientific Title
Practical Validation of a Sensitive AI Robot to Assist Elderly People with Mild Dementia Living Alone
Scientific Title:Acronym
Practical Validation of a Sensitive AI Robot to Assist Elderly People with Mild Dementia Living Alone
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the effectiveness of the intervention and to test the psychological and physical effectiveness of the intervention by randomly assigning the elderly living alone with mild dementia to two groups: with and without intervention by an AI robot to support the elderly living alone with mild dementia.
Basic objectives2
Others
Basic objectives -Others
Looking at changes in stress in elderly people living alone with mild dementia.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stress
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Live with the robot for a week
Interventions/Control_2
Perform data measurement only as a control 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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Elderly with mild dementia living alone
Key exclusion criteria
Elderly people living alone with dementia who were stopped from being included in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Kimura |
Organization
Fukuoka University
Division name
medical faculty
Zip code
8140180
Address
45-1 Nanakuma, Fukuoka City, Fukuoka Prefecture
TEL
0928011011
kimurah@adm.fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Kimura |
Organization
Fukuoka University
Division name
medical faculty
Zip code
8140180
Address
45-1 Nanakuma, Fukuoka City, Fukuoka Prefecture
TEL
0928011011
Homepage URL
Kimurah@adm.fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
Other
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
Fukuoka University
Address
45-1 Nanakuma, Fukuoka City, Fukuoka Prefecture
Tel
0928011011
kimurah@adm.fukuoka-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
| 2023 | Year | 09 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059649
