UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010208 |
|---|---|
| Receipt number | 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 11:25:21 |
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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
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
jimukyoku.murase@jrisp.com
Sponsor or person
Institute
Research Institute of Strategy for Prevention
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011954
