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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029599
Receipt No. R000033809
Scientific Title Development of educational support system for improvement community empowerment of residents in depopulated communities.
Date of disclosure of the study information 2017/10/17
Last modified on 2018/10/18

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Basic information
Public title Development of educational support system for improvement community empowerment of residents in depopulated communities.
Acronym Improvment community empowerment of residents in depopulated communities.
Scientific Title Development of educational support system for improvement community empowerment of residents in depopulated communities.
Scientific Title:Acronym Improvment community empowerment of residents in depopulated communities.
Region
Japan

Condition
Condition Healthy residents in depopulated communities
Classification by specialty
Endocrinology and Metabolism Nursing Adult
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To promote educational interventions on dietary life and exercise and demetia using behavioral change model and to impreve awareness of self-care ability and mutual healp activities.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Empowerment Scale for the Elderly(ESE)
Key secondary outcomes Habits of dietary life and exercise
Self-efficacy
Salting intake status
Body weight
Blood pressure

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Lecture and practice improvement of dietary habits by nutritionist.
2times in 2hours per one time
Lecture and practice about promotion of phsical activity by physical therapist.
6times in 1 to 3hours per one time
Lecture and practice about understanding and support of dementia by dementia care specialist.
6times in 1 to 3hours per one time

Interventions/Control_2
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
7 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Residents in A village
Key exclusion criteria Missing
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Izumi Matsumoto
Organization Kio University
Division name Faculty of health science
Zip code
Address 4-2-2,Umaminaka,Koryocho,Nara
TEL 0745-54-1601
Email i.matsumoto@kio.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Izumi Matsumoto
Organization Kio University
Division name Faculty of health science
Zip code
Address 4-2-2,Umaminaka,Koryocho,Nara
TEL 0745-54-1601
Homepage URL
Email i.matsumoto@kio.ac.jp

Sponsor
Institute Faculty of health science,Kio University
Institute
Department

Funding Source
Organization Ministry of education
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
2017 Year 10 Month 17 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
2017 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 20 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 10 Month 17 Day
Last modified on
2018 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033809

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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