UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060181 |
|---|---|
| Receipt number | R000068764 |
| Scientific Title | Effect of a Preventive Daily Goal Support Program Based on Flow Theory on Quality of Life (QOL) in Middle-Aged and Older Adults: Randomized Control Trial |
| Date of disclosure of the study information | 2025/12/28 |
| Last modified on | 2025/12/23 16:34:05 |
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Basic information
Public title
Study on Daily Activities and Subjective Well-being Using the Life-Goal Support Application "LIFLO"
Acronym
LIFLO-Well-being Study
Scientific Title
Effect of a Preventive Daily Goal Support Program Based on Flow Theory on Quality of Life (QOL) in Middle-Aged and Older Adults: Randomized Control Trial
Scientific Title:Acronym
FLOW-CS Balance Intervention Study
Region
| Japan |
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 specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mental Well-being (WHO-5: WHO-Five Well-Being Index)
Key secondary outcomes
Subjective Quality of Life (Ikigai-9), Flow State Scale for Occupational Tasks, Quantitative trajectory of Challenge-Skill (CS) balance (Log data from the application)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
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.
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
| 60 | years-old | <= |
Age-upper limit
| 75 | 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 sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ippei |
| Middle name | |
| Last name | Yoshida |
Organization
Wakayama Professional University of Rehabilitation
Division name
Faculty of Health Sciences, Department of Occupational Therapy
Zip code
640-8222
Address
3-1 Minatohonmachi, Wakayama, Wakayama
TEL
073-435-4888
liflo.app@gmail.com
Public contact
Name of contact person
| 1st name | Ippei |
| Middle name | |
| Last name | Yoshida |
Organization
Wakayama Professional University of Rehabilitation
Division name
Faculty of Health Sciences, Department of Occupational Therapy
Zip code
640-8222
Address
3-1 Minatohonmachi, Wakayama, Wakayama
TEL
073-435-4888
Homepage URL
liflo.app@gmail.com
Sponsor or person
Institute
Wakayama Professional University of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Wakayama Professional University of Rehabilitation
Address
3-1 Minatohonmachi, Wakayama
Tel
073-435-4888
kyowa@kyowa.ac.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
和歌山リハビリテーション専門職大学 健康科学部 作業療法学専攻
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 28 | 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 | 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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 23 | Day |
Last modified on
| 2025 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068764
