UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063278 |
|---|---|
| Receipt number | R000072366 |
| Scientific Title | Effect of a Participatoryly Developed AI-Based Virtual Link Worker in Reducing Social Isolation and Loneliness Among Older Adults |
| Date of disclosure of the study information | 2026/10/14 |
| Last modified on | 2026/10/14 18:09:14 |
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Basic information
Public title
Effect of a Participatoryly Developed AI-Based Virtual Link Worker in Reducing Social Isolation and Loneliness Among Older Adults
Acronym
Effect of a Participatoryly Developed AI-Based Virtual Link Worker in Reducing Social Isolation and Loneliness Among Older Adults
Scientific Title
Effect of a Participatoryly Developed AI-Based Virtual Link Worker in Reducing Social Isolation and Loneliness Among Older Adults
Scientific Title:Acronym
Effect of a Participatoryly Developed AI-Based Virtual Link Worker in Reducing Social Isolation and Loneliness Among Older Adults
Region
| Japan |
Condition
Condition
older adults who has difficulty participating activities
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the feasibility, acceptability, and exploratory utility of a three-month hybrid intervention for community-dwelling older adults. The intervention combines an AI virtual link worker, which uses participants interests, preferences, and living circumstances identified through AI dialogue together with information on local activities verified by the research team, with ongoing support from peer helpers of a similar age.
The primary outcome is the between-group difference in the change in the total score on the Japanese version of the UCLA Loneliness Scale from baseline to three months, comparing the intervention group with a control group continuing their usual daily lives.
Basic objectives2
Others
Basic objectives -Others
Secondary assessments will measure social participation, motivation, subjective well-being, self-rated health, depressive symptoms, and cognitive and physical function. Intervention acceptability, usage patterns, delivery of peer support, participants experiences, and the processes of behavioural change will be described using both quantitative and qualitative data. Qualitative data will be analysed using thematic analysis following Braun and Clarke (1) six-phase framework.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The between-group difference in the change in the total score on the Japanese version of the UCLA Loneliness Scale from baseline to three months, comparing the intervention group with a control group continuing their usual daily lives.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants receive a three-month hybrid intervention combining an AI virtual link worker with support from peer helpers of a similar age. The AI virtual link worker provides personalised conversational support and introduces opportunities for participation using participants' interests, preferences, and living circumstances identified through dialogue, together with information on local activities verified by the research team. Peer helpers provide ongoing support through regular contact.
Interventions/Control_2
Participants in the control group continue their usual daily lives for three months. During this period, they do not receive support from the AI virtual link worker or peer helpers as part of this study.
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
1. Aged 60 years or older at the time of consent and living independently in the community.
2. Self-reported loneliness, insufficient interaction with others, or difficulties with social participation.
3. Able to understand study information provided in Japanese and personally provide written informed consent.
4. Able to complete the baseline assessment and participate in the study for three months.
Key exclusion criteria
1. Severe cognitive impairment that, in the judgement of the principal investigator, prevents understanding of the study, provision of voluntary informed consent, or completion of study procedures.
2. An acute illness, severe psychiatric symptoms, an unstable health condition, or another condition that makes safe participation difficult.
3. Severe hearing, visual, speech, or physical impairments that make assessments or device use substantially difficult even with reasonable accommodations.
4. Any other circumstances that the principal investigator considers unsuitable for participation on grounds of safety or study conduct.
Prior or current use of generative AI is not a reason for exclusion.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Taki |
Organization
Tohoku University
Division name
Smart-Aging Research Center, Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-8559
yasuyuki.taki.c7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Toshimi |
| Middle name | |
| Last name | Ogawa |
Organization
Tohoku University
Division name
Smart-Aging Research Center, Institute of Development, Aging and Cancer
Zip code
980-8575
Address
4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-8561
Homepage URL
toshimi.ogawa.e6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
others
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.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
東北大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 14 | 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 | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 30 | 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 | 10 | Month | 14 | Day |
Last modified on
| 2026 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072366
