UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062660 |
|---|---|
| Receipt number | R000071729 |
| Scientific Title | Development and Evaluation of the Real-World Implementation Feasibility of a Stratified Self-Care Support Model Integrating Artificial Intelligence and Nursing Expertise Based on Risk Perception Mismatch for Fall Prevention in Older Adults |
| Date of disclosure of the study information | 2026/08/23 |
| Last modified on | 2026/08/23 11:10:08 |
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Basic information
Public title
A Study of AI- and Nurse-Supported Self-Care for Fall Prevention in Older Adults
Acronym
Fall Prevention Study for Older Adults Using AI and Nursing Expertise
Scientific Title
Development and Evaluation of the Real-World Implementation Feasibility of a Stratified Self-Care Support Model Integrating Artificial Intelligence and Nursing Expertise Based on Risk Perception Mismatch for Fall Prevention in Older Adults
Scientific Title:Acronym
RPM-AI Nursing Fall Prevention Study
Region
| Japan |
Condition
Condition
Risk of falls and fractures in older adults
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a stratified self-care support model for community-dwelling older adults that integrates AI-based daily self-care support with support from nursing experts, focusing on risk perception mismatch, RPM, between objective fall and fracture risk and individuals' subjective risk perceptions. Through a three-month intervention, the study will evaluate changes in fear of falling, self-efficacy, physical activity, self-perception, and health behaviors, as well as the acceptability, feasibility, sustainability, and efficiency of the model, to assess its potential for real-world implementation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the following outcomes from baseline (V1) to 3 months after the start of the intervention (V3) will be evaluated as the primary outcomes:
Fear of falling, assessed using the Falls Efficacy Scale-International (FES-I)
Self-efficacy, assessed using a brief self-efficacy scale developed for this study
Physical activity, assessed using the International Physical Activity Questionnaire Short Form (IPAQ-SF)
Indicators of self-perception and verbalization of reasons for health-related behaviors derived from AI dialogue logs
Key secondary outcomes
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
| Behavior,custom | Other |
Interventions/Control_1
All participants will receive self-care support using a research AI system for three months. The AI system will support assessment of lifestyle, physical activity, sleep, and health conditions; explanation of assessment results; daily reflection; verbalization of reasons for successful or unsuccessful health behaviors; review of behavioral goals; and provision of general information on fall prevention and lifestyle improvement. Participants at high risk, defined as those with a history of falls or fragility fractures, will additionally receive consultations with nursing experts to establish feasible behavioral goals based on their lifestyle, values, and risk perceptions. An interim assessment will be conducted one month after the start of the intervention, with an additional nursing consultation provided to high-risk participants as needed. The final assessment will be conducted three months after the start of the intervention.
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
| 65 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals aged 65 to 84 years
Community-dwelling individuals
Individuals with a history of falls or fear of falling, or an interest in fall and fracture prevention
Individuals who are able to use a smartphone
Individuals who are able to use the research AI application or research AI system
Individuals who are able to provide informed consent to participate in the study
Key exclusion criteria
Individuals who have been advised by a physician to restrict physical activity
Individuals with an implanted pacemaker
Individuals certified as requiring support or long-term care under the Japanese long-term care insurance system
Individuals who are unable to provide informed consent or participate in the study due to severe cognitive impairment or other reasons
Individuals considered unsuitable for participation by the principal investigator
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Miyae |
| Middle name | |
| Last name | Yamakawa |
Organization
The University of Osaka
Division name
Division of Health Sciences, Graduate School of Medicine
Zip code
5650871
Address
1-7 Yamadaoka, Suita City, Osaka
TEL
0668792543
miyatabu@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Miyae |
| Middle name | |
| Last name | Yamakawa |
Organization
The University of Osaka
Division name
Division of Health Sciences, Graduate School of Medicine
Zip code
5650871
Address
1-7 Yamadaoka, Suita city, Osaka
TEL
0668792543
Homepage URL
miyatabu@sahs.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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
Ethical Review Board of Osaka University Hospital
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 23 | 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
| 2026 | Year | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 28 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 23 | Day |
Last modified on
| 2026 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071729
