UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024863 |
|---|---|
| Receipt number | 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 | 2023/03/07 10:32:33 |
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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 and managed mainly by local volunteers and locations using IoT and PHR (with local governments and/or business operators' supports) on incidence rate of long-term care insurance certification at individua l 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 (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, social isolation, status of ICT use, number of steps, frequency of going out, 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
10
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
Locations using IoT and PHR(21 hours per 3 weeks, 3 Cools)
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 Iwate prefecture and municipalities of Japan listed as follows: Kobe, Matsudo, Kashiwa, Iwanuma, Matsumoto, Tokai, Nagara, Taketoyo,Sakai, Tokoname, Nagoya 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 | 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-cho, 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/National Center for Geriatrics and Gerontology
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
https://www.jages.net/
umin-ctr@jages.net
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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, Kyoto University,Tokyo Medical and Dental University
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 Prefecture 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
| 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
| 2016 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | 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
| 2016 | Year | 11 | Month | 16 | 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=R000028614
