UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052331 |
|---|---|
| Receipt number | R000059632 |
| Scientific Title | Demonstration of the use of smartphones to screen for frailty and promote health in the "Verification of the association between health maintenance activities and social security cost containment". |
| Date of disclosure of the study information | 2023/09/28 |
| Last modified on | 2024/06/04 10:56:39 |
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Basic information
Public title
Demonstration of the use of smartphones to screen for frailty and promote health in the "Verification of the association between health maintenance activities and social security cost containment".
Acronym
Demonstration of the use of smartphones to screen for frailty and promote health in the "Verification of the association between health maintenance activities and social security cost containment".
Scientific Title
Demonstration of the use of smartphones to screen for frailty and promote health in the "Verification of the association between health maintenance activities and social security cost containment".
Scientific Title:Acronym
Demonstration of the use of smartphones to screen for frailty and promote health in the "Verification of the association between health maintenance activities and social security cost containment".
Region
| Japan |
Condition
Condition
frailty, Health maintenance activities
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to use mobile applications (Kenko-mileage, Frailty Estimation AI) to examine changes in lifestyle and risk of frailty and their relationship to social security cost reduction effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk of frailty
Key secondary outcomes
The risk assessment scale predicting incident functional disability among older people.
Physical health indicators such as frequency of going out and amount of walking as intermediate outcome indicators, psychological health indicators such as depression and subjective sense of health, social health indicators such as social support network, and behavioral changes such as lifestyle.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Using a smartphone application (Kenko-mileage), displaying nudge theory messages such as risk of frailty, lifestyle habits to improve, target values, etc.
Interventions/Control_2
Using a smartphone application (Kenko-mileage), displaying only health mileage without displaying nudge theory messages such as risk of frailty, etc.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age: 65 years or older
2) Gender: male/female, other
3) Other:
Smartphone users
Those who have agreed to participate in this project.
Key exclusion criteria
1) Age: Under 65 years old
2) Other:
Resides outside of Chiba City.
Those who have not agreed to participate in this study.
When valid consent cannot be obtained from the individual due to dementia or other reasons.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Kondo |
Organization
Chiba University
Division name
Center for Preventive Medical Sciences
Zip code
263-8522
Address
1-33 Yayoicho, Inage Ward, Chiba City, Chiba Prefecture 263-8522 Japan
TEL
043-290-3177
umin-ctr@jages.net
Public contact
Name of contact person
| 1st name | Katsunori |
| Middle name | |
| Last name | Kondo |
Organization
Chiba University
Division name
Center for Preventive Medical Sciences
Zip code
263-8522
Address
1-33 Yayoicho, Inage Ward, Chiba City, Chiba Prefecture 263-8522 Japan
TEL
043-290-3177
Homepage URL
umin-ctr@jages.net
Sponsor or person
Institute
Chiba University
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
NTT DOCOMO, INC. X-Tech Development Department
Name of secondary funder(s)
NTT DOCOMO, INC. X-Tech Development Department
IRB Contact (For public release)
Organization
Research ethics committee of the graduate school of m edicine, Chiba university
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture 260-8670 Japan
Tel
043-226-2501
inohana-rinri@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
| 2023 | Year | 09 | 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
6
Results
After merging the first and second questionnaire data provided by Docomo, there were six valid respondents who answered both. Among them, two were in the intervention group and four in the control group. Four respondents (one in the intervention group and three in the control group) had step count data and frailty assessment results from the frailty estimation AI. Consequently, we could not evaluate the intervention effect using the frailty estimation AI as initially planned.
Results date posted
| 2024 | Year | 06 | Month | 04 | Day |
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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059632
