UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060410 |
|---|---|
| Receipt number | R000069109 |
| Scientific Title | A Feasibility and Acceptability Study of a Large Language Model Enabled Companion Robot for Older People Living Alone |
| Date of disclosure of the study information | 2026/01/21 |
| Last modified on | 2026/01/20 14:42:54 |
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Basic information
Public title
A Feasibility and Acceptability Study of a Large Language Model Enabled Companion Robot for Older People Living Alone
Acronym
A Feasibility and Acceptability Study of a Large Language Model Enabled Companion Robot for Older People Living Alone
Scientific Title
A Feasibility and Acceptability Study of a Large Language Model Enabled Companion Robot for Older People Living Alone
Scientific Title:Acronym
A Feasibility and Acceptability Study of a Large Language Model Enabled Companion Robot for Older People Living Alone
Region
| Japan |
Condition
Condition
Older people living alone
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the feasibility and acceptability of long-term (12-week) in-home use of a conversational companion robot equipped with a large language model (LLM).
1. To assess the feasibility of using the improved robot as a potential approach to alleviating loneliness.
2. To explore how older people develop and maintain relationships with an AI-enabled robot during long-term use in their own homes.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Outcome: 12-week usage retention rate
Definition: Proportion of participants who achieve "successful use" over the 12-week home-use period.
Successful use: Meeting the minimum use threshold in >=80% of evaluable weeks, defined as >=20 minutes/day on >=3 days/week.
Handling of dropout: Weeks after withdrawal are counted as evaluable weeks and treated as not meeting the threshold.
Evaluable week: A week not primarily affected by travel, hospitalisation, or other force majeure circumstances, prespecified and verified using system logs and participant reports.
Data source: Device/server logs collected via NTT West Japan servers (number of device activations, number of dialogue sessions, cumulative dialogue time), supplemented by manual records if needed.
Key secondary outcomes
Consent rate: number of participants who provided informed consent/number of individuals who received a one-to-one study explanation
Number of adverse events occurring during the study period
Use frequency and duration (number of device activations, number of dialogue sessions, cumulative dialogue time)
Number of requests for technical support
Number of researcher visits prompted by technical issues
Change in CCR (Connection-Coordination Rapport) scale scores (rapport)
Change in B-LAPS-Ro (Brief Lexington Attachment to Pets Scale-Robot version) scores (attachment)
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
We will install a conversational companion robot equipped with a large language model (LLM) in the homes of older adults living alone and conduct a 12-week in-home use period. At the start of the study, the research team will set up the device and provide instructions on its operation; thereafter, participants will interact with the robot as they wish in their daily lives. Although the research team has a target level of use, participants will be informed that they may use the robot freely. During the intervention period, usage logs (e.g., number of activations, number of dialogue sessions, and cumulative dialogue time) will be collected via a server. If technical problems occur, support will be provided by telephone and, where necessary, through researcher home visits. Participants will generally continue their usual daily activities and usual care. The intervention will be discontinued at the participant's request or for safety reasons (e.g., adverse events).
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 aged 65 or older who live alone.
Key exclusion criteria
Diagnosed dementia
Uncontrolled physical illness or severe psychiatric conditions
Hearing impairment significantly impeding spoken communication (not adequately compensated by hearing devices)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Ikeda |
Organization
The University of Osaka
Division name
Department of Psychiaitry
Zip code
5650871
Address
D3, 2-2 Yamadaoka, Suita, Osaka, Japan
TEL
0668793051
mikeda@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Satake |
Organization
The University of Osaka
Division name
Department of Psychiatry
Zip code
5650871
Address
D3, 2-2 Yamadaoka, Suita, Osaka, Japan
TEL
0668793051
Homepage URL
y.satake@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
NTT West
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board Osaka University Hospital
Address
1-1 Yamadaoka, Suita, Osaka, Japan
Tel
06-6877-5111
rinri@hp-crc.med.osaka-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
| 2026 | Year | 01 | Month | 21 | 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 | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 12 | 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 | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069109
