Tokyo, Sept. 14 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062904) titled 'A study of the effects of generative AI-assisted reflection on daily habits on health and functional capacity in older adults' on Sept. 14.
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 - Prevention of age-related decline in functional capacity and frailty in older adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To examine the effects and feasibility of a 3-month generative AI-assisted lifestyle reflection intervention on the maintenance of functional capacity and health-related behaviors in older adults, with a focus on enhancing self-awareness and self-efficacy.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Participants receive a 3-month generative AI-assisted conversational intervention to support reflection on daily lifestyle. The AI supports reflection on physical activity, sleep, physical condition, mood, diet, and outings; helps participants verbalize reasons for successful or unsuccessful behaviors; reviews personal goals; and provides general information on health maintenance and fall prevention. Health assessments and feedback are provided at baseline, approximately 1.5 months, and 3 months. At the end of the intervention, participants undergo an interview based on a summary of AI conversations and assessment results. The AI does not provide diagnosis, treatment, or medication advice.
Eligibility:
Age-lower limit - 60
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Inclusion criteria
Age 60 years or older.
Able to communicate in Japanese.
Able to use the tablet device installed in the participant's room.
Able and willing to provide written informed consent to participate in the study.
Key exclusion criteria - Exclusion criteria
Individuals who have been advised by their attending physician to restrict physical activity or exercise.
Individuals for whom participation in the study is considered difficult due to severe cognitive impairment or other conditions.
Individuals with severe visual or hearing impairment that makes study assessments or operation of the study tools difficult.
Individuals whom the principal investigator determines to be unsuitable for participation in the study.
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 09 Day
Anticipated trial start date - 2026 Year 10 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072025
Disclaimer: Curated by HT Syndication.