UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042330 |
|---|---|
| Receipt number | R000048318 |
| Scientific Title | Research on creation of services to promote behavioral change by using IoT to prevent Long-term Care |
| Date of disclosure of the study information | 2020/11/02 |
| Last modified on | 2023/03/07 10:23:43 |
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Basic information
Public title
Research on creation of services to promote behavioral change by using IoT to prevent Long-term Care
Acronym
Research on creation of services to promote behavioral change by using IoT to prevent Long-term Care
Scientific Title
Research on creation of services to promote behavioral change by using IoT to prevent Long-term Care
Scientific Title:Acronym
Research on creation of services to promote behavioral change by using IoT to prevent Long-term Care
Region
| Japan |
Condition
Condition
Deterioration of living function, depression, social isolation,loneliness
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the extent to which behavioral changes, such as social participation, will occur by creating communities that encourage people to participate using IoT and other technologies, and to estimate the extent to which these changes will improve health (intermediate) outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
depression
Key secondary outcomes
Self-rated health, instrumental activities of daily living, physical function (locomotive function, history of fall etc), psychological function (happiness etc), social function (including inside and outside the internet social network, social support, social participation etc), oral function, sleep condition, eating habits, cognitive function, risk assessment scales for needed long-term care, frail, status of ICT use, number of steps, frequency of going out , social isolation,loneliness etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Locations using IoT and PHR(21 hours per 3 weeks , 3 Cool)
Interventions/Control_2
Locations without using IoT and PHR
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
Community-dwelling older adults (living in municipalities of Japan listed as follows: Matsudo, Sakai)
Key exclusion criteria
Needed Long-Term Care , Loss of independence in activities of daily living
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Kondo |
Organization
Chiba University/National Center for Geriatrics and Gerontology
Division name
Center for Preventive Medical Sciences/Center for Gerontology and Social Science
Zip code
263-8522/474-8511
Address
1-33 Yayoicho, Inage Ward, Chiba City, Chiba Prefecture 263-8522 Japan/7-430 Morioka-ch o, Obu City, Aichi Prefecture 474-8511 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/Center for Gerontology and Social Science
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, National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Geriatrics and Gerontology, Matsudo City, Sakai City
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of the graduate school of medicine, Chiba university
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefect ure 260-8670 Japan
Tel
043-226-2501
igaku-rinri@office.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
| 2020 | Year | 11 | Month | 02 | 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
| 2020 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 13 | 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
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048318
