UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A community-wide intervention trial for preventing or reducing frailty among older adults living in metropolitan areas
Title of the study (Brief title)	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	Shoji Shinkai
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Vice director
Address	35-2 Sakae-cho, Itabashi, Tokyo
TEL	03-3964-3241
Email	sshinkai@tmig.or.jp

Public contact
Name of contact person	Naomi Hasegawa
Organization	Tokyo Metropolitan Institute of Gerontology
Division name	Corporate Planning department
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000030451