Tokyo, Oct. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063278) titled 'Effect of a Participatoryly Developed AI-Based Virtual Link Worker in Reducing Social Isolation and Loneliness Among Older Adults' on Oct. 14.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Placebo

Primary Sponsor: Institute - Tohoku University

Condition: Condition - older adults who has difficulty participating activities Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 14 Day Anticipated trial start date - 2026 Year 10 Month 28 Day Last follow-up date - 2028 Year 03 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072366

Disclaimer: Curated by HT Syndication.