UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029599 |
|---|---|
| Receipt number | 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 | 2020/10/22 13:25:47 |
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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 | Izumi |
| Middle name | |
| Last name | Matsumoto |
Organization
Kio University
Division name
Faculty of health science
Zip code
635-0832
Address
4-2-2,Umaminaka,Koryocho,Nara
TEL
0745-54-1601
i.matsumoto@kio.ac.jp
Public contact
Name of contact person
| 1st name | Izumi |
| Middle name | |
| Last name | Matsumoto |
Organization
Kio University
Division name
Faculty of health science
Zip code
635-0832
Address
4-2-2,Umaminaka,Koryocho,Nara
TEL
0745-54-1601
Homepage URL
i.matsumoto@kio.ac.jp
Sponsor or person
Institute
Faculty of health science,Kio University
Institute
Department
Personal name
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
Kio University
Address
4-2-2,Umaminaka,Koryocho,Nara
Tel
0745-54-1601
i.matsumoto@kio.ac.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
| 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
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 17 | Day |
Last modified on
| 2020 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033809
