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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042737
Receipt No. R000048783
Scientific Title A Study of Factors Affecting the Formation and Propagation of Traditional Health Literacy among the Elderly in Ogimi Village, Okinawa, Japan
Date of disclosure of the study information 2020/12/30
Last modified on 2020/12/13

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Basic information
Public title Ogimi Village Health Literacy Propagation Study for the Super Elderly
Acronym OHLPSE
Scientific Title A Study of Factors Affecting the Formation and Propagation of Traditional Health Literacy among the Elderly in Ogimi Village, Okinawa, Japan
Scientific Title:Acronym OHLPSE
Region
Japan

Condition
Condition Adult
Classification by specialty
Rehabilitation medicine Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To record and analyze the traditional health literacy formation factors and the propagation history of specific acts and behaviors that enhance health, and to clarify the relationship with ADL independence as a cohort study in the fifth year.
Basic objectives2 Others
Basic objectives -Others To identify the collection of information in the formation of health literacy, to clarify the propagation to utilization, and to analyze the relationship between literacy and vascular function and exercise capacity.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes ADL self-supporting degree(12 months after the last evaluation)
HLS-EU-Q47

Key secondary outcomes HLS-EU-Q47
Pulse wave Velocity
FR
Body fat volume
Muscle volume rate
Diabetes medication
Hypertension
Abnormal hyperlipidemia
Health information source information

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Conduct FR test by presenting a concrete object (set up a ball 1m in front of them and ask them to push it. 3 trials)
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
85 years-old <=
Age-upper limit
110 years-old >=
Gender Male and Female
Key inclusion criteria Over 85 years old.
Must not be hospitalized.
Must be a local resident living at home.
Must be able to move indoors and outdoors by themselves.
Must be able to understand and follow movement instructions.
Key exclusion criteria Under 85 years old.
Undergoing inpatient treatment.
Not living at home in the community at the time of measurement.
Unable to move indoors and outdoors by himself.
Unable to understand movement instructions.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Akira Kimura
Middle name Kimura
Last name Kimura
Organization Gunma Paz University
Division name Division of Physical Therapy
Zip code 370-0006
Address 1-7-1,Tonyamachi,Takasaki-City,Gunma
TEL 0273880865
Email kimuaki@nifty.com

Public contact
Name of contact person
1st name Akira
Middle name
Last name kimura
Organization Gunma Paz University
Division name Division of Physical Therapy
Zip code 3700006
Address 1-7-1,Tonyamachi,Takasaki-City,Gunma
TEL 08050153631
Homepage URL http://kimuakilabo.main.jp/
Email kimuaki@nifty.com

Sponsor
Institute kimuakilabo, Gunma PARS University
Institute
Department

Funding Source
Organization Gunma Paz University Research Institute
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Ogimi Village Council of Social Welfare
Name of secondary funder(s)

IRB Contact (For public release)
Organization GUNMA PAZ UNIVERSITY
Address Takasaki
Tel 0273880865
Email a-kimura@paz.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 Ogimi Village Citizen Center(Okinawa)

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 30 Day

Related information
URL releasing protocol http://kimuakilabo.main.jp/
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 16
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
2020 Year 08 Month 15 Day
Date of IRB
2020 Year 07 Month 22 Day
Anticipated trial start date
2020 Year 09 Month 01 Day
Last follow-up date
2021 Year 01 Month 08 Day
Date of closure to data entry
2021 Year 01 Month 15 Day
Date trial data considered complete
2021 Year 01 Month 22 Day
Date analysis concluded
2021 Year 01 Month 29 Day

Other
Other related information

Management information
Registered date
2020 Year 12 Month 13 Day
Last modified on
2020 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048783

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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