Tokyo, July 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062215) titled 'Feasibility study of a conversational AI robot and room temperature management to support older adults' daily life and health' on July 12.

Study Type: Interventional

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

Primary Sponsor: Institute - Yokohama City University

Condition: Condition - Social isolation and loneliness in older adults Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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(2) aged 65 years or older; (3) no diagnosis of dementia; (4) able to converse in Japanese; (5) socially isolated or withdrawn (any of: LSNS-6 total score of 12 or lower; spending most of the daytime in their own room; non-participation in facility recreational activities); (6) in-room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 Size - 3

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071197

Disclaimer: Curated by HT Syndication.