UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062511 |
|---|---|
| Receipt number | R000071560 |
| Scientific Title | Validation of the Feasibility and Psychometric Properties of the Japanese Versions of MoCA XpressO and MoCA CHAI |
| Date of disclosure of the study information | 2026/08/20 |
| Last modified on | 2026/08/07 15:14:27 |
* 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
A Study on the Feasibility of the Japanese Versions of MoCA XpressO and MoCA CHAI
Acronym
A Study on the Feasibility of the Japanese Versions of MoCA XpressO and MoCA CHAI
Scientific Title
Validation of the Feasibility and Psychometric Properties of the Japanese Versions of MoCA XpressO and MoCA CHAI
Scientific Title:Acronym
Validation of the Feasibility and Psychometric Properties of the Japanese Versions of MoCA XpressO and MoCA CHAI
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the feasibility and psychometric properties of the Japanese versions of MoCA XpressO and MoCA CHAI self-check digital tools-among Japanese-speaking community-dwelling older adults.
Basic objectives2
Others
Basic objectives -Others
Verification of feasibility, reliability, and validity
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of participants who completed MoCA XpressO and MoCA CHAI in full without interruption.
Key secondary outcomes
Independent completion rate: The proportion of participants who completed the test(s) without non-cognitive operational assistance from research staff.
Missing data, discontinuation, and technical problems: Number of missing items, reasons for discontinuation, problems related to device/connectivity/audio/input, and content of operational assistance provided.
Time required: Descriptive statistics of the total time required for each tool and the time required for each major section.
Linguistic naturalness and usability: Questionnaire scores will be described, and interview content will be categorized into themes such as "instructions," "item wording," "result display," "screen operation," "audio," and "device."
Score distribution: The distribution of total scores and scores for each category will be examined, including ceiling effects, floor effects, and outliers.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Community-dwelling individuals aged 60 years or older at the time of consent.
-Individuals who use Japanese in daily life and are able to respond to the tests and questionnaires in Japanese.
-Individuals who have received an explanation of the purpose and content of the study, have understood it, and are able to voluntarily provide written consent to participate in the study.
Key exclusion criteria
-Individuals judged to be unable to complete the study procedures due to visual, auditory, motor, or other impairments that make it difficult to view the device screen, understand audio instructions, or perform screen input. However, individuals who are able to complete the procedures with the standard level of operational guidance or non-cognitive operational assistance will not be excluded.
-Individuals who have taken the MoCA-J within the past 1 month.
-Individuals judged by the principal investigator or a co-investigator to be inappropriate for participation in this study due to their physical condition, circumstances on the day of assessment, or other reasons. For example, individuals in whom the effects of alcohol consumption, etc., on cognitive function assessment are evident will be excluded.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Suzuki |
| Middle name | |
| Last name | Hiroyuki |
Organization
Tokyo Metroploitan Institute for Geriatrics and Gerotology
Division name
Research Team for Social Participation and Healthy Aging
Zip code
173-0015
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo, Japan
TEL
03-3964-3241
suzukihy@tmig.or.jp
Public contact
Name of contact person
| 1st name | Ogawa |
| Middle name | |
| Last name | Susumu |
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Division name
Research Team for Social Participation and Healthy Aging
Zip code
173-0015
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo, Japan
TEL
03-3964-3241
Homepage URL
suzukihy@tmig.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Eli Lilly Japan K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Institute for Geriatrics and Gerontology
Address
35-2 Sakae-cho,Itabashi-ku, Tokyo, 173-0015,Japan
Tel
03-3964-3241
kouhou@tmghig.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
| 2026 | Year | 08 | 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
| 2026 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | 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
Recruitment of study participants will be outsourced to the Itabashi Silver Human Resources Center. The principal investigator or a co-investigator will hold an explanatory session for prospective participants recruited through the Center, explaining the purpose and methods of the study, the voluntary nature of participation, the freedom to withdraw, the handling of personal information, remuneration, and other relevant matters. Informed consent will be obtained by the principal investigator or a co-investigator, and staff of the Silver Human Resources Center will not be involved in the consent process. Participants will be informed that neither declining to participate nor withdrawing consent will result in any disadvantage to their membership activities at the Center or to future work assignments.
Management information
Registered date
| 2026 | Year | 08 | Month | 07 | Day |
Last modified on
| 2026 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071560
