UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059590 |
|---|---|
| Receipt number | R000068103 |
| Scientific Title | Examination of the Change in Quality of Life through an Environmental Sensor-Based Stress Estimation and Coping Feedback System for Healthy Individuals |
| Date of disclosure of the study information | 2025/11/11 |
| Last modified on | 2025/11/10 12:14:50 |
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Basic information
Public title
Examination of the Change in Quality of Life through an Environmental Sensor-Based Stress Estimation and Coping Feedback System for Healthy Individuals
Acronym
Examination of the Change in Quality of Life through an Environmental Sensor-Based Stress Estimation and Coping Feedback System for Healthy Individuals
Scientific Title
Examination of the Change in Quality of Life through an Environmental Sensor-Based Stress Estimation and Coping Feedback System for Healthy Individuals
Scientific Title:Acronym
Examination of the Change in Quality of Life through an Environmental Sensor-Based Stress Estimation and Coping Feedback System for Healthy Individuals
Region
| Japan |
Condition
Condition
No specific disease identified
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related QOL: SF-36 (Medical Outcomes Study 36-Item Short-Form Health Survey)
Key secondary outcomes
QOL assessment: EQ-5D-5L (EuroQol 5 Dimensions 5-Level), 5 items
Mood assessment: Profile of Mood States, Second Edition (POMS 2), Adult Short Form
Brief Job Stress Questionnaire (BJSQ): 29 items on stress responses (from the original 57-item version)
Checklist for Activities of Daily Living for Preventive Care (25 items)
Japanese version of the Client Satisfaction Questionnaire (CSQ-8J), 8 items
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Medicine, Chiba University
Division name
Cognitive Behavioral Physiology
Zip code
2608670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Chiba Prefecture, Japan
TEL
0432262069
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Medicine, Chiba University
Division name
Cognitive Behavioral Physiology
Zip code
2608670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Chiba Prefecture, Japan
TEL
0432262069
Homepage URL
eiji@faculty.chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University, Cognitive Behavioral Physiology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Internal Affairs and Communications
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba, Chiba Prefecture, Japan
Tel
0432262069
eiji@faculty.chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068103
