UMIN-CTR Clinical Trial

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://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011954