Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059590) titled 'Examination of the Change in Quality of Life through an Environmental Sensor-Based Stress Estimation and Coping Feedback System for Healthy Individuals' on Nov. 11.

Study Type: Interventional

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

Primary Sponsor: Institute - Graduate School of Medicine, Chiba University, Cognitive Behavioral Physiology

Condition: Condition - No specific disease identified Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to examine changes in self-administered questionnaire scores related to quality of life before and after independent individuals living alone use a system that estimates four emotional states (stress, arousal, fatigue, and comfort) with high accuracy through artificial intelligence (AI) based on data collected from non-contact environmental sensors installed in their rooms and contact-type wristband sensors worn for two months. The system provides feedback on the estimated emotional states as well as guidance on coping strategies for physical and chemical stressors via the free messaging application offered by LINE Corporation. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will receive approximately one hour of instruction on the feedback system that utilizes sensors and the free messaging application LINE (provided by LINE Corporation), followed by approximately one hour to complete self-administered questionnaires assessing quality of life and related factors before the intervention. After that, for a period of two months, participants will place the developed environmental sensors in their rooms and wear a wristband-type sensor in their daily lives. They will receive daily feedback for about 15 minutes via the LINE application on a loaned smartphone (mobile device). After the two-month intervention period, participants will again complete post-intervention questionnaires, which will take approximately one hour to finish.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Adults aged 18 years or older 2. Individuals living alone in a private independent-type retirement home 3. Individuals certified as independent not requiring support or nursing care according to the eight-level classification of care needs - that is not certified as Support Level from 1 to 2 or Care Level from 1 to 5 4. Individuals capable of placing environmental sensors in their rooms and using a wristband-type sensor 5. Individuals able to receive messages via the messaging application on the loaned smartphone mobile device 6. Individuals who after receiving a full explanation of the study demonstrate adequate understanding and provide written informed consent of their own free will to participate Key exclusion criteria - 1. Individuals who have serious illnesses or conditions with activity limitations that, in the judgment of the investigators, may affect the participants' safety or the conduct of this study (cancer, heart disease, severe respiratory disease, severe endocrine disease, stroke, dementia, physical disability, intellectual disability, mental disorder, alcohol dependence, or other serious progressive physical illnesses) 2. Individuals who are currently participating in another study Target Size - 10

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 15 Day Anticipated trial start date - 2025 Year 12 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=R000068103

Disclaimer: Curated by HT Syndication.