UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059741 |
|---|---|
| Receipt number | R000068318 |
| Scientific Title | Development of a Comprehensive Health Advice Generation and Health Counseling Support System |
| Date of disclosure of the study information | 2025/11/11 |
| Last modified on | 2025/11/11 18:43:19 |
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Basic information
Public title
Development of a Comprehensive Health Advice Generation and Health Counseling Support System
Acronym
Development of a Comprehensive Health Advice Generation and Health Counseling Support System
Scientific Title
Development of a Comprehensive Health Advice Generation and Health Counseling Support System
Scientific Title:Acronym
Development of a Comprehensive Health Advice Generation and Health Counseling Support System
Region
| Japan |
Condition
Condition
Frailty
Classification by specialty
| Medicine in general | Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop and implement a comprehensive health advice generation and health guidance support system suitable for installation in elderly care facilities and to verify its usefulness. Medical-grade measuring devices are used to conduct multifaceted assessments of physical function, cognitive function, sleep, and mental health, and a proprietary algorithm is used to automatically generate personalized comprehensive health advice. This advice does not complete health guidance on its own; rather, it is presented in conjunction with an interview support tool, helping to streamline and focus individual interviews by public health nurses.
The primary outcome to be verified in this study is satisfaction with public health nurse interviews. We will determine whether the introduction of an advice and interview support system can shorten interview time even with limited professional resources while providing support that is convincing to the recipient. Furthermore, we will secondary-assess the feasibility of on-site implementation by evaluating advice comprehension, willingness to change behavior, and tool usability. Through these efforts, this study aims to demonstrate the nature of sustainable and efficient health guidance in a super-aging society and lay an important foundation for both scientific and social success.
This study is based on a comprehensive intervention model implemented in previous research, and will introduce a portable configuration using existing equipment and AI support tools to optimize its operation.The purpose is not to compare with a non-intervention group, but to primarily examine the usefulness of information organization and promotion of understanding in comprehensive intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
This is the level of satisfaction with interviews using the comprehensive health advice and health guidance support system. Interview satisfaction is measured using a questionnaire that uses a Likert scale, and evaluated by aggregating the distribution.
Key secondary outcomes
Secondary measures include understanding of advice, willingness to change behavior, and tool usability.
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
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
The intervention in this study consists of a series of steps: surveys and measurements, the presentation of automatically generated advice (assistance tools), and individual interviews with public health nurses. Specifically, subjects undergo non-invasive assessments such as grip strength, walking speed, body composition, simple tests of cognitive function, simple scales for depression and insomnia, and sleep monitoring. Based on these measurement data, a research algorithm automatically generates comprehensive health advice. This advice is presented to subjects using a tablet or PC, and then the public health nurse conducts an individual interview based on the advice. The interview is focused according to the subject's level of understanding and motivation, and the required time is limited to approximately 20 minutes. The entire procedure is considered a single intervention and will be carried out once for each subject. No medication or invasive procedures are involved.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Facility users residing in the facility
(Criteria for facility use include being able to walk independently and being 60 years of age or older)
2.Individuals who can provide written consent to participate in the study
Key exclusion criteria
1.Subjects with significant visual or hearing impairments that make it difficult to take measurements or operate tools
2.Subjects deemed ineligible by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Yamamoto |
Organization
The University of Osaka Graduate School of Medicine
Division name
Geriatric and General Medicine
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3852
kyamamoto@geriat.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Fujimoto |
Organization
The University of Osaka Graduate School of Medicine
Division name
Geriatric and General Medicine
Zip code
565-0871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3852
Homepage URL
takufuji@geirat.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
The Society 5.0 Implementation Research Hub Support Program
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Osaka Hospital Ethics Review Committee
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
| 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 | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 11 | Month | 11 | Day |
Last modified on
| 2025 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068318
