UMIN-CTR Clinical Trial

Basic information
Public title	A research on the feasibility and effectiveness of ICT-based care prevention model (online kayoi-no-ba) in the post COVID-19 Era.
Acronym	A research on the feasibility and effectiveness of ICT-based care prevention model (online kayoi-no-ba) in the post COVID-19 Era.
Scientific Title	A research on the feasibility and effectiveness of ICT-based care prevention model (online kayoi-no-ba) in the post COVID-19 Era.
Scientific Title:Acronym	A research on the feasibility and effectiveness of ICT-based care prevention model (online kayoi-no-ba) in the post COVID-19 Era.
Region	Japan

Condition
Condition	lonliness, social isolation, depression, deterioration of living function
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The research objective is to evaluate the effectiveness of ICT-based care prevention model (online kayoi-no-ba) for reducing risks of long-term care, and to examine its feasibility and sustainability.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	loneliness
Key secondary outcomes	depression, social isolation, self-rated health, happiness, positive emotion, instrumental activities of daily living, frail, risk assessment scales for needed long-term care, social function (including inside and outside the internet social network, social support, social participation etc), status of ICT use, frequency of going out,frequency of laghter 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
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	The exposure to ICT-based care prevention model (online kayoi-no-ba) for about 2 months
Interventions/Control_2	Without the exposure to ICT-based care prevention model (online kayoi-no-ba)
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 people(including healthy people)
Key exclusion criteria	Under 65 years old
Target sample size	854

Research contact person
Name of lead principal investigator	1st name Katsunori Middle name Last name Kondo
Organization	Chiba University/Japan Agency for Gerontological Evaluation Study/National Center for Geriatrics and Gerontology
Division name	Center for Preventive Medical Sciences/-/Center for Gerontology and Social Science
Zip code	263-8522/110-0001/474-8511
Address	1-33 Yayoicho, Inage Ward, Chiba City, Chiba Prefecture 263-8522 Japan/ 6-3-5 Yanaka Taito-ku Tokyo 110-0001 Japan/ 7-430 Morioka-cho, Obu City, Aichi Prefecture 474-8511 Japan
TEL	043-290-3177
Email	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
Email	umin-ctr@jages.net

Sponsor
Institute	Chiba University
Institute
Department

Funding Source
Organization	MHLW(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japan Agency for Gerontological Evaluation Study, National Center for Geriatrics and Gerontology, Matsudo City, Sakai City, Takatsuki City, Fujiidera City, Ikeda City, Moriguchi City, Tondabayashi City, Ashiya City, Sanda City, Sumoto City, NTT DOCOMO, INC., HankyuHanshin Holdings,Inc. etc
Name of secondary funder(s)	Ministry of Internal Affairs and Communications, Mitsubishi Foundation, Japan Science and Technology Agency, NTT DOCOMO, INC.

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
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	2021 Year 08 Month 20 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	2021 Year 08 Month 17 Day
Date of IRB	2021 Year 08 Month 17 Day
Anticipated trial start date	2021 Year 08 Month 22 Day
Last follow-up date	2026 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	2021 Year 08 Month 20 Day
Last modified on	2022 Year 08 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051650