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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023260
Receipt No. R000026804
Scientific Title Evaluation of the effectiveness of booklet-based health guidance on elderly Japanese-Brazilians.
Date of disclosure of the study information 2016/07/20
Last modified on 2016/07/20

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Basic information
Public title Evaluation of the effectiveness of booklet-based health guidance on elderly Japanese-Brazilians.
Acronym Evaluation of the effectiveness of booklet-based health guidance on elderly Japanese-Brazilians.
Scientific Title Evaluation of the effectiveness of booklet-based health guidance on elderly Japanese-Brazilians.
Scientific Title:Acronym Evaluation of the effectiveness of booklet-based health guidance on elderly Japanese-Brazilians.
Region
South America

Condition
Condition Elderly Japanese-Brazilians: who aged more than 65 years old, and receive regular health checkups by home visiting program
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effectiveness of booklet based health guidance by the indicators described below. The indicators are health literacy, self-efficacy, satisfaction with health status, and physical measurement.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Health literacy
Key secondary outcomes Self efficacy, Satisfaction to health, Abdominal circumference, Body mass index, Blood pressure, Neutral fat, HDL-C, LDL-C, Fasting blood glucose, HbA1c, Salt intake

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 Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Booklet-based 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 person who can conduct a daily conversation in Japanese.
Key exclusion criteria The person who cannot conduct a daily conversation in Japanese.
The person who assessed inadequate to participate the research by the medical 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 School of Medical College of Nursing
Zip code
Address 3-9 Fukuura,Kanazawa-ku,Yokohama
TEL 045-787-2542
Email 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 School of Medical College of Nursing
Zip code
Address 3-9 Fukuura,Kanazawa-ku,Yokohama
TEL 045-787-2753
Homepage URL
Email mkanno@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization MEXT
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
2016 Year 07 Month 20 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 Preinitiation
Date of protocol fixation
2016 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 23 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
2016 Year 07 Month 20 Day
Last modified on
2016 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026804

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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