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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042330
Receipt No. 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 2020/11/02

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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
Email kkondo@chiba-u.jp

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
Email kkondo@chiba-u.jp

Sponsor
Institute Chiba University, National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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 Preinitiation
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
2021 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
2020 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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