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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020260
Receipt No. R000023237
Scientific Title The validity study of newly developed self-monitoring system that can utilize for health guidance of urinary Na/K meter and home blood pressure monitor with function of measurement of nighttime blood pressure as a feasibility study using small number of survey in rural area of Japan
Date of disclosure of the study information 2016/01/08
Last modified on 2016/01/21

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Basic information
Public title The validity study of newly developed self-monitoring system that can utilize for health guidance of urinary Na/K meter and home blood pressure monitor with function of measurement of nighttime blood pressure as a feasibility study using small number of survey in rural area of Japan
Acronym A ccomparison test of urinary Na/K ratio and home blood pressure
Scientific Title The validity study of newly developed self-monitoring system that can utilize for health guidance of urinary Na/K meter and home blood pressure monitor with function of measurement of nighttime blood pressure as a feasibility study using small number of survey in rural area of Japan
Scientific Title:Acronym A ccomparison test of urinary Na/K ratio and home blood pressure
Region
Japan

Condition
Condition Mild Hypertensive patients categolized as 1st class degrees in a resident of Sichigahama-mach, Japan
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate wether home blood pressure monitors and urinary Na / K ratio measuring by self-monitoring devices can be useful to make the dietary advice by a dietician in Shichigahama-machi, Miyagi, Japan.
Basic objectives2 Others
Basic objectives -Others To verify whether the effect of an education about sodium restriction on home blood pressure
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes To verify whether the measurement of urinary Na/K ratio and home blood pressure can continue more than 70% of the obligatory time point 2 weeks after the intervention
Key secondary outcomes To verify whether home blood pressure is reduced by dietary advice

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Dietary education (especially sodium intake restriction),onece
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
40 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria First degrees hypertension or its suspicion cases
Key exclusion criteria (1) severe renal insufficiency
(2) subjects having history of cardiovascular disease within a year
(3) secondary hypertension such as a case of primary aldosteronism and renovascular hypertension
(4) subjects who already have thiazide antihypertensive diuretics for controling of hypertension
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyasu Kiyomoto, M.D.& Ph.D
Organization Tohoku Medical Megabank Organization, Tohoku University
Division name Department of Community Medical Supports
Zip code
Address 2-1 Seiryo-cho Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-273-6289
Email kiyo@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyasu Kiyomoto, M.D.& Ph.D
Organization Tohoku Medical Megabank Organization, Tohoku University
Division name Department of Community Medical Supports
Zip code
Address 2-1 Seiryo-cho Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-273-6289
Homepage URL http://hkiyo.jimdo.com/Home
Email kiyo@megabank.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku Medical Megabank Organization, Tohoku University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 七ヶ浜町(宮城県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 08 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 01 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 08 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
2016 Year 09 Month 30 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 17 Day
Last modified on
2016 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023237

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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