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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024863
Receipt No. R000028614
Scientific Title Effects of Preventive Long-term Care Projects by community development on incidence rate of long-term care insurance certification at individual and community levels: Japan Gerontological Evaluation Study project's Community Intervention Trial (JAGES COMMIT)
Date of disclosure of the study information 2016/12/01
Last modified on 2017/05/24

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Basic information
Public title Effects of Preventive Long-term Care Projects by community development on incidence rate of long-term care insurance certification at individual and community levels: Japan Gerontological Evaluation Study project's Community Intervention Trial (JAGES COMMIT)
Acronym Effects of Preventive Long-term Care Projects by community development on incidence rate of long-term care insurance certification at individual and community levels: a community intervention trial
Scientific Title Effects of Preventive Long-term Care Projects by community development on incidence rate of long-term care insurance certification at individual and community levels: Japan Gerontological Evaluation Study project's Community Intervention Trial (JAGES COMMIT)
Scientific Title:Acronym Effects of Preventive Long-term Care Projects by community development on incidence rate of long-term care insurance certification at individual and community levels: a community intervention trial
Region
Japan

Condition
Condition Long-term care insurance certification
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of the spread of community activities managed mainly by local volunteers (with local governments and/or business operators' supports) on incidence rate of long-term care insurance certification at individual and community levels.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Long-term care insurance certification
Key secondary outcomes Self-rated health, instrumental activities of daily living, physical function (locomotive function, history of fall, etc.), psychological function (depression, happiness, etc.), social function (social network, social support, social participation, etc.), oral function, sleep condition, eating habits, cognitive function, risk assessment scales for needed long-term care, etc.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 9
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Participating in community activities managed by local volunteers (exercise program, 4 times/month, for 36 months)
Interventions/Control_2 Participating in community activities managed by local volunteers (exercise program, twice a month, for 36 months)
Interventions/Control_3 Participating in community activities managed by local volunteers (exercise program, once a month, for 36 months)
Interventions/Control_4 Participating in community activities managed by local volunteers (hobby program, 4 times/month, for 36 months)
Interventions/Control_5 Participating in community activities managed by local volunteers (hobby program, twice a month, for 36 months)
Interventions/Control_6 Participating in community activities managed by local volunteers (hobby program, once a month, for 36 months)
Interventions/Control_7 Participating in community activities managed by local volunteers (cafe program, 4 times/month, for 36 months)
Interventions/Control_8 Participating in community activities managed by local volunteers (cafe program, twice a month, for 36 months)
Interventions/Control_9 Participating in community activities managed by local volunteers (cafe program, once a month, for 36 months)
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: Kobe, Matsudo, Kashiwa, Iwanuma, Matsumoto, Tokai, Nagara, Taketoyo, etc.)
Key exclusion criteria Needed Long-Term Care
Loss of independence in activities of daily living
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsunori 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
Address 1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture 260-8670 Japan/7-430 Morioka-cho, Obu City, Aichi Prefecture 474-8511 Japan
TEL 043-226-2803
Email kkondo@chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsunori 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
Address 1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture 260-8670 Japan/7-430 Morioka-cho, Obu City, A
TEL 043-226-2803
Homepage URL https://www.jages.net/
Email kkondo@chiba-u.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization MEXT(Japan), Japan Agency for Medical Research and Development(Japan)
, The Japan Foundation for Aging and Health(Japan), Matsudo City(Japan), Nagara Town(Japan), Tokai City(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor The University of Tokyo, Tohoku University, Hamamatsu University School of Medicine, Nihon Fukushi University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 12 Month 01 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
2016 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 09 Month 30 Day
Date trial data considered complete
2020 Year 09 Month 30 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 11 Month 16 Day
Last modified on
2017 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028614

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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