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 2026/03/30 17:28:42

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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

Email

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


Email

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

Email

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

Published


Result

URL related to results and publications

https://www.pref.shizuoka.jp/_res/projects/default_project/_page_/001/053/278/r4r5ketsuatumatome.pdf

Number of participants that the trial has enrolled

244

Results

A home blood pressure measurement habit project was implemented in Fiscal Years 2022-2023, targeting 244 employees from 12 workplaces. During 60 days, 168 participants (73.4%) measured on 40+ days. Pre-project measurement habit participants increased from 77 (40.3%) to 230 (95.4%) after completion. At 2-6 months post-project, 114 participants (58.2%) maintained the habit. Workplace engagement and colleague presence were cited by 106 of 243 respondents (43.6%) as factors for sustained measurement.

Results date posted

2026 Year 03 Month 30 Day

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

Completed

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

2025 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

2022 Year 12 Month 06 Day

Last modified on

2026 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056623