UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032443 |
|---|---|
| Receipt number | R000036999 |
| Scientific Title | The effect of health guidance using booklet for elderly Japanese ancestry in Brazil. |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2021/11/04 09:40:17 |
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Basic information
Public title
The effect of health guidance using booklet for elderly Japanese ancestry in Brazil.
Acronym
Health guidance using booklet for elderly Japanese ancestry in Brazil.
Scientific Title
The effect of health guidance using booklet for elderly Japanese ancestry in Brazil.
Scientific Title:Acronym
Health guidance using booklet for elderly Japanese ancestry in Brazil.
Region
| Japan | South America |
Condition
Condition
The Japanese elderly ancestry in Brazil (age>65)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of health guidance using booklet for Japanse elderly ancestry on health literacy, self-efficacy, satisfaction, and the data of physical examination including blood pressure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health literacy, self-efficacy, satisfaction, and the data of physical examination including blood pressure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Using booklet for annual health guidance
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The Japanese elderly ancestry aged over 65 who can have coversation in Japanese and consented for this study.
Key exclusion criteria
People who are not recommended for participation by doctor .
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuka Kanoya |
Organization
Yokohama City University
Division name
Nursing Course, School of Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2542
ykano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mana Doi |
Organization
Yokohama City University
Division name
Nursing Course, School of Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2753
Homepage URL
mkanno@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
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
| 2018 | Year | 05 | Month | 01 | 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
| 2016 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | 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
| 2018 | Year | 05 | Month | 01 | Day |
Last modified on
| 2021 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036999
| 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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