UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045993 |
|---|---|
| Receipt number | R000052502 |
| Scientific Title | Development of an AI-based system to identify frailty in community residents |
| Date of disclosure of the study information | 2021/11/05 |
| Last modified on | 2021/11/05 18:59:24 |
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Basic information
Public title
Development of an AI-based system to identify frailty in community residents
Acronym
Development of an AI-based system to identify frailty in community residents
Scientific Title
Development of an AI-based system to identify frailty in community residents
Scientific Title:Acronym
Development of an AI-based system to identify frailty in community residents
Region
| Japan |
Condition
Condition
Adults living in the community
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a system that identifies frailty in community residents by AI-based analysis of sensors installed in homes and records of lifeline use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frailty Assessment (grip strength, walking speed, etc.)
Key secondary outcomes
Recording of sensors (smart meter, motion sensor, etc.)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a. Lives alone in the community.
b. Consented to participate in the study.
Key exclusion criteria
None.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Kitamura |
Organization
Fujita Health University
Division name
Faculty of Rehabilitation, School of Health Sciences
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562-93-9000
Homepage URL
shin.kitamura@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Chubu Electric Power Company,Incorporated
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chubu Electric Power Company,Incorporated
necolico LLC
Japan Data Science Consortium Co. Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
藤田医科大学（愛知県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Various sensors, such as motion sensors and smart meters to detect electricity usage, will be installed in homes of community residents who have provided written informed consent to participate in the study. Participants will be assessed for frailty on a regular basis. Develop a model to identify frailty using some of the acquired data, and verify the accuracy of the model using the remaining data.
Management information
Registered date
| 2021 | Year | 11 | Month | 05 | Day |
Last modified on
| 2021 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052502
