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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017028
Receipt No. R000019747
Scientific Title Effect of community activities by education of care prevention supporters exerting in health for frail elderly and supporters themselves and social capital index
Date of disclosure of the study information 2015/04/06
Last modified on 2019/04/05

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Basic information
Public title Effect of community activities by education of care prevention supporters exerting in health for frail elderly and supporters themselves and social capital index
Acronym Effects of education of preventive care supporters on the social capital index in the community
Scientific Title Effect of community activities by education of care prevention supporters exerting in health for frail elderly and supporters themselves and social capital index
Scientific Title:Acronym Effects of education of preventive care supporters on the social capital index in the community
Region
Japan

Condition
Condition Frail elderly
Classification by specialty
Geriatrics Orthopedics Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Education and activities of preventive care supporters, and to clarify the impact on social capital intensity of the health state and regional in frail elderly and the supporters themselves.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Timed Up and Go Test
Key secondary outcomes Social capital index

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention: The exercise carried by preventive care supporters
Interventions/Control_2 Control: Health education
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 Preventive care supporters: Healthy adults
Subjects in preventive care class: Person who has been determined that the frail elderly in the basic checklist on preventive care subjects by the Ministry of Health, Labour and Welfare.
Key exclusion criteria A person who has severe heart disease, high blood pressure, a moderate or severe cognitive dysfunction.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuhiko Takatori
Organization Kio University
Division name Faculty of health ascience
Zip code
Address 635-0832
TEL 0745-54-1601
Email k.takatori@kio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuhiko Takatori
Organization Kio University
Division name Faculty of health science
Zip code
Address 635-0832
TEL 0745-54-1601
Homepage URL
Email k.takatori@kio.ac.jp

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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
2015 Year 04 Month 06 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 No longer recruiting
Date of protocol fixation
2015 Year 03 Month 31 Day
Date of IRB
2015 Year 03 Month 01 Day
Anticipated trial start date
2015 Year 03 Month 31 Day
Last follow-up date
2020 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
2015 Year 04 Month 02 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019747

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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