UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062215 |
|---|---|
| Receipt number | R000071197 |
| Scientific Title | Feasibility of a conversational AI robot with IoT-based room temperature management for socially isolated older adults in serviced senior housing: a single-arm mixed-methods pilot study |
| Date of disclosure of the study information | 2026/07/12 |
| Last modified on | 2026/07/12 12:15:45 |
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Basic information
Public title
Feasibility study of a conversational AI robot and room temperature management to support older adults' daily life and health
Acronym
AI Robot Feasibility Study
Scientific Title
Feasibility of a conversational AI robot with IoT-based room temperature management for socially isolated older adults in serviced senior housing: a single-arm mixed-methods pilot study
Scientific Title:Acronym
AI Robot Feasibility Study
Region
| Japan |
Condition
Condition
Social isolation and loneliness in older adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility of an intervention combining an in-room conversational AI robot with IoT-based room temperature management, in preparation for a full-scale randomized controlled trial. Five prespecified dimensions are evaluated against progression criteria: (1) implementation of the devices, (2) practicality of summer room-temperature management, (3) practicality of assisted questionnaire administration, (4) demand (spontaneous robot use), and (5) acceptability.
Basic objectives2
Others
Basic objectives -Others
Feasibility study
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility indicators assessed over the 12-week intervention period: (1) retention rate at endpoint; (2) proportion of days with normal device operation; (3) robot use (median number of conversation days per week); (4) capture rate of temperature/humidity sensor data and success rate of the heat-safety system when room temperature exceeds the thresholds (robot-delivered verbal prompts and alert display on the facility-office tablet); (5) questionnaire completion rate, administration time, and item-level need for assisted administration; (6) safety (adverse events and serious psychological distress events). All indicators are evaluated against prespecified progression criteria.
Key secondary outcomes
(1) Individual-level changes from baseline to endpoint in social isolation (LSNS-6), loneliness (6-item de Jong Gierveld scale; 3-item UCLA scale), depressive symptoms (GDS-5), and self-rated health (single item), reported descriptively without statistical testing; (2) robot conversation logs (frequency, duration, time of day); (3) qualitative evaluation by semi-structured exit interviews (content analysis of acceptability and self-reported changes in daily life and social interaction).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Placement of a commercially available conversational AI robot in the participant's room for approximately 12 weeks. A one-time operating instruction (about 5 minutes) is provided at installation, followed by periodic usage guides (e.g., leaflets) to support continued use. Use of the robot remains at the participant's discretion. The robot is configured to encourage participation in facility events and social interaction.Two-tier heat-safety management via an in-room temperature/humidity sensor (approximately 12 weeks): (a) when room temperature reaches 27.5 degrees Celsius or higher, the robot verbally prompts the participant to use the air conditioner; (b) when room temperature exceeds 28 degrees Celsius, an alert is displayed on a tablet placed in the facility office (temperatures of the three rooms are displayed continuously and highlighted in red above the threshold), and facility staff telephone the resident to check on heat conditions, visiting the room if high temperature persists.
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
(1) Residents of serviced senior housing; (2) aged 65 years or older; (3) no diagnosis of dementia; (4) able to converse in Japanese; (5) socially isolated or withdrawn (any of: LSNS-6 total score of 12 or lower; spending most of the daytime in their own room; non-participation in facility recreational activities); (6) in-room Wi-Fi installation possible; (7) written informed consent obtained from the participant.
Key exclusion criteria
(1) Severe hearing impairment; (2) long-term care need level 3 or higher; (3) life expectancy judged to be less than 3 months; (4) current participation in another interventional study.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Hara |
Organization
Yokohama City University
Division name
School of Economics and Business Administration
Zip code
2360027
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872131
hara.koj.vv@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Hara |
Organization
Yokohama City University
Division name
School of Economics and Business Administration
Zip code
2360027
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872131
Homepage URL
hara.koj.vv@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Koji Hara
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
The conversational AI robot and temperature/humidity sensors are provided free of charge by a private company.
IRB Contact (For public release)
Organization
Research Ethics Committee of the Hakkei Campus, Yokohama City University
Address
22-2 Seto, Kanazawa-ku, Yokohama, Kanagawa, Japan
Tel
045-787-2354
sangaku@yokohama-cu.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
民間事業者運営のサービス付き高齢者向け住宅1施設（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 12 | 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
3
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2026 | Year | 10 | 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 | 07 | Month | 12 | Day |
Last modified on
| 2026 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071197
