UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053116 |
|---|---|
| Receipt number | R000060575 |
| Scientific Title | Prospective cohort study of digital and bio-information from healthy older people to explore common characteristics. |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2024/03/26 15:22:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective cohort study of digital and bio-information from healthy older people to explore common characteristics.
Acronym
Prospective cohort study of digital and bio-information from healthy older people to explore common characteristics.
Scientific Title
Prospective cohort study of digital and bio-information from healthy older people to explore common characteristics.
Scientific Title:Acronym
Prospective cohort study of digital and bio-information from healthy older people to explore common characteristics.
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Obtain digital and bio-information from healthy older people and explore common characteristics and their association with healthy longevity.
Basic objectives2
Others
Basic objectives -Others
To achieve efficient and high quality health services.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Digital information(for 12 months from the start of the study,24 months for those who agree to an extension)
Background investigation,quality of life survey,physical function tests and laboratory tests(at the beginning and 12th month,at the end of the study(24th month)for those who agree to an extension)
Key secondary outcomes
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese men and women aged 80 years or older at the time consent is obtained.
2)Persons who have given written consent to participate in this study.
3)People who can wear a wearable device during sleep.
4)Persons who can charge the wearable device themselves or a family member.
5)People who can perform simple operations on the loaned tablet by touching the screen.
Key exclusion criteria
1)People certified as requiring nursing care 2 or above.
2)People with clearly impaired cognitive function.
3)People with a history or current illness that causes cognitive decline.
4)people with clinically significant diseases.
5)People who are participating in clinical research or clinical trials of other medicines or foods.
6)Persons who are judged to be inappropriate as subjects by the principal investigator or research assistant.
Target sample size
155
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | Svensson |
| Last name | Kishi |
Organization
The University of Tokyo
Division name
Precision Health Department of Bioengineering,Graduate School of Engineering
Zip code
113-8656
Address
7-3-1Hongo,Bunkyo-ku,Tokyo,Japan
TEL
03-5841-6696
akiko-kishi@umin.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | Svensson |
| Last name | Kishi |
Organization
The University of Tokyo
Division name
Precision Health Department of Bioengineering,Graduate School of Engineering
Zip code
113-8656
Address
7-3-1Hongo,Bunkyo-ku,Tokyo
TEL
03-5841-6696
Homepage URL
https://precision.t.u-tokyo.ac.jp/
akiko-kishi@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
collaborative research funds
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
Research Ethics Committee of the University of Tokyo
Address
7-3-1Hongo,Bunkyo-ku,Tokyo
Tel
080-7494-2644
lifescience.adm@gs.mail.u-tokyo.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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 15 | 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
150
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 12 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060575
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
