UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049709 |
|---|---|
| Receipt number | R000056623 |
| Scientific Title | Empirical research on the habituation of home blood pressure measurement in employees |
| Date of disclosure of the study information | 2022/12/07 |
| Last modified on | 2023/10/06 18:13:25 |
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Basic information
Public title
Empirical research on the habituation of home blood pressure measurement in employees
Acronym
Habituation of home blood pressure measurement
Scientific Title
Empirical research on the habituation of home blood pressure measurement in employees
Scientific Title:Acronym
Habituation of home blood pressure measurement
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and feasibility of an intervention program aimed to habituate to measure home blood pressure in employees of small and medium-sized companies in Shizuoka Prefecture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of home blood pressure measurement
Key secondary outcomes
Changes in home blood pressure level
Changes in awareness of blood pressure measurement
Changes in awareness of lifestyle improvement
Promoting and inhibitory factors for home blood pressure measurement
Number of visits to medical clinic
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Home blood pressure measurement
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Employees in medium-to-small size companies in Shizuoka Prefecture
Key exclusion criteria
individuals who have difficulty in Japanese communication
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Tabara |
Organization
Shizuoka Graduate University of Public Health
Division name
Shizuoka Graduate University of Public Health
Zip code
420-0881
Address
4-27-2 Kitaanndo,Aoi-ku,Shizuoka,Japan
TEL
054-295-5401
kyomu@s-sph.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Shimamura |
Organization
Shizuoka Prefecture
Division name
Health Promotion
Zip code
420-0881
Address
9-6,Ote-machi,Aoi-ku,Shizuoka
TEL
054-221-2437
Homepage URL
kenzou@pref.shizuoka.lg.jp
Sponsor or person
Institute
Shizuoka Graduate University of Public Health
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shizuoka Prefecture
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Graduate University of Public Health, Ethics Committee
Address
4-27-2, Kitaando, Aoi-ku, Shizuoka, Japan
Tel
+81-54-295-5401
info@s-sph.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056623
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
