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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000010208
Receipt No. R000011954
Scientific Title Efficacy of health education on persons exempted from specific health guidance in Japan
Date of disclosure of the study information 2013/04/01
Last modified on 2021/09/16

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Basic information
Public title Efficacy of health education on persons exempted from specific health guidance in Japan
Acronym Health education on exempts from specific health guidance in Japan
Scientific Title Efficacy of health education on persons exempted from specific health guidance in Japan
Scientific Title:Acronym Health education on exempts from specific health guidance in Japan
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify efficacy of a long-running health education program of by health insures given to patients on hypertetensive medication.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change in medical cost
Key secondary outcomes Changes in salt intake, body weight, level of physical activities, blood pressure

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Dietary education (salt reduction, increase of potassium intake, control of body weight)
Interventions/Control_2 Physical activity education
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
40 years-old <=
Age-upper limit
72 years-old >=
Gender Male and Female
Key inclusion criteria One who uset antihypertensive at specific health checkup (SHC) in 2011, and still used it at the time of enrollment of the study.
Key exclusion criteria SBP>=180mmHg or DBP>=100mmHg at SHC in 2011.
One who may have difficulties during health education because of low back pain or knee pain.
One who has history of stroke or ischemic heart disease.
One who doctor judged not suitable for the study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Okayama
Organization Research Institute of Strategy for Prevention
Division name Department of Strategy Research
Zip code 103-0006
Address 10-14, Tomizawa-cho, Nihonbashi, Chuo-ku, Tokyo
TEL +81-50-3823-0100
Email aokayama@risp.com

Public contact
Name of contact person
1st name Yuu
Middle name
Last name Murase
Organization Research Institute of Strategy for Prevention
Division name Department of Strategy Research
Zip code 103-0006
Address 10-14, Tomizawa-cho, Nihonbashi, Chuo-ku, Tokyo
TEL +81-50-3823-0100
Homepage URL
Email jimukyoku.murase@jrisp.com

Sponsor
Institute Research Institute of Strategy for Prevention
Institute
Department

Funding Source
Organization MHLW of Japan
Ministry of Education of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Insittute of Health and Nutrition
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical committee of Japan anti-tubervulosis association
Address Misakicho 1-3-12, Chiyoda-ku, Tokyo, JAPAN
Tel +81-3-3292-9215
Email s-jimukyoku@jatahq.org

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 合同会社生活習慣病予防研究センター

Other administrative information
Date of disclosure of the study information
2013 Year 04 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 116
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2022 Year 12 Month 01 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
2012 Year 04 Month 01 Day
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2015 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
2013 Year 03 Month 11 Day
Last modified on
2021 Year 09 Month 16 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011954

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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