UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059677 |
|---|---|
| Receipt number | R000068235 |
| Scientific Title | Development of a tool to support assessment of dementia using an interactive robot with less burden on the elderly. |
| Date of disclosure of the study information | 2025/11/07 |
| Last modified on | 2025/11/07 10:45:35 |
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Basic information
Public title
Development of a tool to support assessment of dementia using an interactive robot with less burden on the elderly.
Acronym
Development of a tool to support assessment of dementia using an interactive robot.
Scientific Title
Development of a tool to support assessment of dementia using an interactive robot with less burden on the elderly.
Scientific Title:Acronym
Development of a tool to support assessment of dementia using an interactive robot.
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop a conversational assessment system that evaluates cognitive function through free, natural dialogue with a robot equipped with an interactive dialogue system, called WANCO. Unlike conventional tools such as the HDS-R, this system seeks to determine cognitive status without formal testing. We will validate its effectiveness by comparing its assessments with scores obtained from the HDS-R.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
The primary outcome will be the correlation coefficient between the total HDS-R score assessed by a physician and the cognitive function score estimated by WANCO (HDS-R-equivalent total score). For the physician-assessed HDS-R score, we will use the most recent score obtained within one year prior to the WANCO assessment. If a documented HDS-R score within the past year is available in the medical record or referral letter, that score will be used. If no such record exists, a new HDS-R assessment will be conducted by a physician at the participating facility, the principal investigator, a co-investigator, or a collaborating physician.
Key secondary outcomes
1)Sensitivity of the WANCO-based cognitive assessment in detecting dementia
2)Specificity of the WANCO-based cognitive assessment in detecting dementia
3)Identification of factors associated with dementia using a logistic regression model based on WANCO-derived assessment results
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Each session will consist of a ~10-minute conversation with WANCO, a robot equipped with a conversational AI system.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling older adults affiliated with the participating facilities, comprising cognitively healthy individuals, persons diagnosed with dementia, and those with mild cognitive impairment (MCI).
Key exclusion criteria
Individuals exhibiting agitation, those for whom meaningful interaction with WANCO is not feasible, and those who decline or are unable to provide informed consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Ohira |
Organization
St. Marianna University School of Medicine
Division name
Depaertment od General Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa 216-8511 Japan
TEL
044-977-8111
yohira@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Ohira |
Organization
St. Marianna University School of Medicine
Division name
Depaertment od General Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa 216-8511 Japan
TEL
044-977-8111
Homepage URL
yohira@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki city, Kanagawa 216-8511 Japan
Tel
044-977-8111
yohira@marianna-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
| 2025 | Year | 11 | Month | 07 | 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
| 2025 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068235
