UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056234 |
|---|---|
| Receipt number | R000063930 |
| Scientific Title | Research on the effects of understanding and improving loneliness and isolation through remote monitoring of health conditions and social prescriptions using wearable devices |
| Date of disclosure of the study information | 2024/11/22 |
| Last modified on | 2025/10/17 15:50:56 |
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Basic information
Public title
Research on the effects of understanding and improving loneliness and isolation through remote monitoring of health conditions and social prescriptions using wearable devices
Acronym
Research on loneliness monitoring using wearable devices
Scientific Title
Research on the effects of understanding and improving loneliness and isolation through remote monitoring of health conditions and social prescriptions using wearable devices
Scientific Title:Acronym
Research on the effects of understanding and improving loneliness and isolation through remote monitoring of health conditions and social prescriptions using wearable devices
Region
| Japan |
Condition
Condition
healthy individuals aged 50 and older
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the issues and needs related to loneliness and social isolation among the target local residents.
To explore the relationship between data obtained from wrist-worn wearable devices and feelings of loneliness or social isolation.
To determine whether early intervention using digital biomarkers, such as monitoring systems, can help improve loneliness or social isolation among individuals in these conditions, including recommending medical consultations or implementing social prescribing.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of the UCLA Loneliness Scale with biometric sensing data acquired from wearable devices.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Social prescriptions such as visits to cafes attached to clinics, exercise and gymnastics classes, existing hobby clubs, and skill matching, as well as advice from medical personnel to research subjects with reference to information from wearable devices
Interventions/Control_2
No intervention for the group of people experiencing loneliness
Interventions/Control_3
No intervention for the group of people without a sense of loneliness
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
iduals aged 50 and over at the time of registration
Those who can regularly visit Otawa Clinic in Shirako Town, Chosei District, Chiba Prefecture, or a location designated by the researcher
Individuals who can use a smartphone capable of installing a wearable device app
Those able to wear a smartwatch-type wearable device
Individuals who have consented to participate in this study or who participated in a previous study conducted by TechDoctor and have agreed to the secondary use of their data (may be used as control data)
Key exclusion criteria
Those who cannot participate in social prescribing activities (e.g., visits to cafes, exercise classes, existing hobby clubs, skill matching, etc.) if they are assigned to a group of social prescribing activities.
Those who are deemed by the researcher to be inappropriate to participate in this study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Izumi |
Organization
Tech Doctor, Inc.
Division name
Board Member
Zip code
104-0031
Address
4th Floor, Kyobashi Edogrand, 2-2-1 Kyobashi, Chuo-ku, Tokyo
TEL
03-5476-8889
shirako-mimamori@technology-doctor.com
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Kouzaka |
Organization
Tech Doctor Inc.
Division name
Corporate Planning Department
Zip code
104-0031
Address
4th Floor, Kyobashi Edogrand, 2-2-1 Kyobashi, Chuo-ku, Tokyo
TEL
03-5476-8889
Homepage URL
shirako-mimamori@technology-doctor.com
Sponsor or person
Institute
Tech Doctor, Inc.
Institute
Department
Personal name
Funding Source
Organization
PwC Foundation, Public Interest Incorporated Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hillside Clinic Jingumae Institutional Review Board (IRB)
Address
Hillside Clinic Jingumae Institutional Review Board (IRB)
Tel
03-3470-1188
naoki-kitazawa@cmicgroup.com
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
| 2024 | Year | 11 | Month | 22 | 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
61
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
Completed
Date of protocol fixation
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 22 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 22 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063930
