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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026515
Receipt No. R000030451
Scientific Title A community-wide intervention trial for preventing or reducing frailty among older adults living in metropolitan areas
Date of disclosure of the study information 2017/03/12
Last modified on 2018/09/13

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Basic information
Public title A community-wide intervention trial for preventing or reducing frailty among older adults living in metropolitan areas
Acronym A community-wide intervention trial for preventing frailty
Scientific Title A community-wide intervention trial for preventing or reducing frailty among older adults living in metropolitan areas
Scientific Title:Acronym A community-wide intervention trial for preventing frailty
Region
Japan

Condition
Condition frailty
Classification by specialty
Geriatrics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To create a social mechanism (i.e., intervention content) that postpones frailty and examine its effectiveness.
Basic objectives2 Others
Basic objectives -Others To examine the requirements for it to spread to other communities (transferability).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Check-List 15 score and prevalence of frailty (i.e. score of 4 and above)
Key secondary outcomes Physical activity and physical function
Dietary variety
Social activity and psychosocial function

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom Other
Interventions/Control_1 Intervention/the interventions that focus on improving dietary variety and physical and social activities will be conducted with respect to each intervention cluster as participatory action research.
Interventions/Control_2 Control/usual health practices will be conducted.
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
84 years-old >=
Gender Male and Female
Key inclusion criteria Adults aged 65-84 years old living in Ota City, Tokyo.
Key exclusion criteria Individual with long-term care insurance certification and those admitted to hospitals or residing in nursing homes were excluded.
Target sample size 15500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoji Shinkai
Organization Tokyo Metropolitan Institute of Gerontology
Division name Vice director
Zip code
Address 35-2 Sakae-cho, Itabashi, Tokyo
TEL 03-3964-3241
Email sshinkai@tmig.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naomi Hasegawa
Organization Tokyo Metropolitan Institute of Gerontology
Division name Corporate Planning department
Zip code
Address 35-2 Sakae-cho, Itabashi, Tokyo
TEL 03-3964-3241
Homepage URL
Email naomi_hasegawa@tmghig.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

Funding Source
Organization Ota City
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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
2017 Year 03 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

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 No longer recruiting
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 12 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030451

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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