Tokyo, Jan. 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060410) titled 'A Feasibility and Acceptability Study of a Large Language Model Enabled Companion Robot for Older People Living Alone' on Jan. 21.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - The University of Osaka

Condition: Condition - Older people living alone Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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).

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 Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 20 Day Anticipated trial start date - 2026 Year 01 Month 24 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069109

Disclaimer: Curated by HT Syndication.