Tokyo, Dec. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060181) titled 'Study on Daily Activities and Subjective Well-being Using the Life-Goal Support Application "LIFLO"' on Dec. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Placebo

Primary Sponsor: Institute - Wakayama Professional University of Rehabilitation

Condition: Condition - Prevention of non-specific decline in life functioning, Maintenance of mental and physical health (Healthy adults / Middle-aged and older adults) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To improve the Quality of Life (QOL) of middle-aged and older adults, experiencing "Flow states" - where the balance between "challenges" and "skills" in daily activities is optimized - is crucial. This study aims to clarify whether a preventive occupational therapy intervention using the Remote-Adjusting the Challenge Skill balance (R-ACS), specifically the application "LIFLO," contributes to the maintenance and improvement of subjective well-being and life functioning. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will use the smartphone application "LIFLO-AI," equipped with generative AI (Gemini 2.5 Flash), for 8 weeks. The AI, which has been trained on the activity support method applying Flow Theory (Adjusting the Challenge-Skill balance) and the support process using the PEO (Person-Environment-Occupation) model of occupational therapy, analyzes and supports the adjustment of the balance between challenge and skill levels (CS balance) based on the user's daily activity logs. To ensure that users experience an optimal CS balance, the AI provides specific advice (RegoalAI) approximately once or twice a week to adjust the difficulty of activities, the environment, or the methods, thereby promoting behavioral change. Interventions/Control_2 - Participants will use a smartphone application "LIFLO-Lite," which has restricted AI analysis and advisory functions (RegoalAI), for 8 weeks. Similar to the intervention group, participants will perform goal setting, practice daily activities, and enter self-evaluations of "challenge" and "skill" levels along with their reflections. However, no personalized feedback or adjustment suggestions from the AI will be provided; instead, only standardized encouraging messages (e.g., "Saved! Great job!") will be displayed upon completion of entry. This group serves to control for the placebo effect (Hawthorne effect) of app usage itself to verify the specific efficacy of the AI-driven adjustment functions.

Eligibility: Age-lower limit - 60 years-old

Gender - Male and Female Key inclusion criteria - 1. Community-dwelling older adults aged 60 to 75 years. 2. Regular smartphone users who are capable of operating applications and performing text entry independently. 3. Willingness to use the application consistently throughout the 8-week study period. 4. Provided informed consent voluntarily (written or electronic) after receiving a full explanation of the study's purpose and methods. 5. Possessing sufficient visual, auditory, and cognitive functions to use the application without significant difficulty. Key exclusion criteria - 1. Individuals who require daily assistance from family or others for activities of daily living (i.e., those in a state of requiring long-term care). 2. Individuals currently receiving medical treatment for depression or other mental disorders. 3. Individuals suspected of cognitive decline equivalent to the Mini-Mental State Examination (MMSE) based on screening questionnaires. 4. Any other individuals judged by the principal investigator to be inappropriate for participation in this study. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 28 Day Date of IRB - 2025 Year 07 Month 01 Day Anticipated trial start date - 2026 Year 01 Month 15 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068764

Disclaimer: Curated by HT Syndication.