UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042737 |
|---|---|
| Receipt number | 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 21:02:31 |
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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
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/
kimuaki@nifty.com
Sponsor or person
Institute
kimuakilabo, Gunma PARS University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048783
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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