UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061903 |
|---|---|
| Receipt number | R000070833 |
| Scientific Title | Cognitive and Psychosocial Effects of a Communication Robot Intervention in Community-Dwelling Older Adults Living Alone or with Others: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/14 20:09:25 |
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Basic information
Public title
Cognitive and Psychosocial Effects of Communication Robot Intervention in Community-Dwelling Older Adults
Acronym
CoRo Study
Scientific Title
Cognitive and Psychosocial Effects of a Communication Robot Intervention in Community-Dwelling Older Adults Living Alone or with Others: A Randomized Controlled Trial
Scientific Title:Acronym
CARE Study
Region
| Japan |
Condition
Condition
Community-Dwelling Older Adults Living Alone or with Others
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of a communication robot intervention on memory function, loneliness, depression, and social frailty in community-dwelling older adults living alone or with others.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Logical Memory I and II scores of the Wechsler Memory Scale
Key secondary outcomes
MoCA-J
WHOQOL-OLD
LSI-Z
GDS-15
Short-form UCLA
NCGG-SGS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will have a BOCCO emo communication robot installed in their homes and will use it to communicate with family members and others. No predetermined frequency of communication will be specified. Participants will receive a diary and will be asked to record robot use and their impressions on the days it is used.
Interventions/Control_2
Participants in the control group will maintain their usual lifestyle without the communication robot intervention.
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
Adults aged 65 years or older.
Individuals who are able to understand how to use the communication robot.
Individuals who use a mobile phone.
Key exclusion criteria
Individuals with severe cognitive impairment.
Individuals with severe visual or hearing impairment that interferes with the use of the communication robot.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Katsushi |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto-ku, Osaka 536-8525, Japan
TEL
0661671264
yokoikat@omu.ac.jp
Public contact
Name of contact person
| 1st name | Katsushi |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
536-8525
Address
2-1-132 Morinomiya, Joto-ku, Osaka 536-8525, Japan
TEL
0661671264
Homepage URL
yokoikat@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Rehabilitation Science, Osaka Metropolitan University
Address
2-1-132 Morinomiya, Joto-ku, Osaka 536-8525, Japan
Tel
0661671264
yokoikat@omu.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
| 2026 | Year | 06 | Month | 15 | 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 | 12 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 08 | 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
Management information
Registered date
| 2026 | Year | 06 | Month | 14 | Day |
Last modified on
| 2026 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070833
