UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020260 |
|---|---|
| Receipt number | 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 09:34:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kiyo@megabank.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
