UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063425 |
|---|---|
| Receipt number | R000071790 |
| Scientific Title | An Intervention Study on the Effectiveness of Home Blood Pressure Monitoring and Online Form-Based Lifestyle Intervention for Employees with Elevated Blood Pressure Identified at Routine Workplace Health Examinations |
| Date of disclosure of the study information | 2026/10/27 |
| Last modified on | 2026/10/27 10:57:49 |
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Basic information
Public title
Home Blood Pressure Monitoring and Online Form-Based Intervention for Employees with Elevated Blood Pressure Identified at Routine Workplace Health Examinations
Acronym
A Study of Home Blood Pressure Monitoring and Online Lifestyle Support for Employees with Elevated Blood Pressure at Workplace Health Checkups
Scientific Title
An Intervention Study on the Effectiveness of Home Blood Pressure Monitoring and Online Form-Based Lifestyle Intervention for Employees with Elevated Blood Pressure Identified at Routine Workplace Health Examinations
Scientific Title:Acronym
Workplace Home Blood Pressure Monitoring and Online Lifestyle Intervention Study (W-HOME Study)
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate whether an intervention consisting of home blood pressure monitoring and lifestyle assessment using an online form, followed by either written lifestyle modification guidance based on the home blood pressure and health examination results or face-to-face lifestyle counseling with a recommendation to seek medical care, is effective in improving lifestyle behaviors, reducing blood pressure, and increasing the proportion of participants receiving antihypertensive medication among employees with systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg at routine workplace health examinations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Systolic and diastolic blood pressure measured at the routine workplace health examination in the year following study enrollment.
Key secondary outcomes
The following parameters assessed at the routine workplace health examination in the year following study enrollment: body weight, waist circumference, body mass index (BMI), triglycerides, LDL cholesterol, HDL cholesterol, total cholesterol, HbA1c, estimated salt intake, smoking habits, alcohol consumption habits, exercise habits, use of antihypertensive medication, use of lipid-lowering medication, and use of antidiabetic medication.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Participants will use an upper-arm blood pressure monitor (HEM-7281T, OMRON Healthcare Co., Ltd.) linked to the OMRON connect smartphone application. After informed consent, researchers will assist participants in installing the application, connecting it to the provided monitor, and confirming data transfer.
Participants will measure home blood pressure twice in the morning within 1 hour after waking and before breakfast, and twice before bedtime, for at least 7 days.
Participants will report the 7-day average home blood pressure shown in the application and their current lifestyle habits to the study office using an online form accessed by QR code. If the application cannot be used, participants will read the 7-day average morning and evening blood pressure values from the monitor and report the higher value.
Researchers will obtain participants' 2024 routine workplace health examination results from the General Affairs Division of Kamaishi City.
Cardiovascular and cerebrovascular risk will be assessed based on the 2024 health examination results, average home blood pressure, and lifestyle information. Participants at low or moderate risk will receive written lifestyle modification guidance. High-risk participants will receive face-to-face lifestyle counseling and a recommendation to seek medical care, with appointments arranged by email.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Kamaishi City employees who had a systolic blood pressure >=140 mmHg and/or a diastolic blood pressure >=90 mmHg at the 2024 routine employee health examination and who routinely use a smartphone.
Key exclusion criteria
Individuals aged 65 years or older.
Individuals who routinely measure and record their home blood pressure approximately once a week or more.
Individuals who do not plan to undergo the 2025 routine employee health examination.
Individuals for whom blood pressure lowering has been restricted by a physician.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Omama |
Organization
Iwate Medical University
Division name
Department of General Medicine, School of Medicine
Zip code
0208505
Address
19-1, Uchimaru, Morioka, Iwate Prefecture
TEL
0196136111
somama@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Omama |
Organization
Iwate Medical University
Division name
Department of General Medicine, School of Medicine
Zip code
0208505
Address
19-1, Uchimaru, Morioka, Iwate Prefecture
TEL
0196136111
Homepage URL
somama@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Shinichi Omama
Funding Source
Organization
Government of Iwate Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Iwate Medical University
Address
1-1-1, Idai-dori, Yahaba, Shiwa-gun, Iwate 028-3694
Tel
+81-19-651-5111
kenkyu-rinri@j.iwate-med.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
| 2026 | Year | 10 | Month | 27 | 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
38
Results
From the 2024 to the 2025 health checkup, mean SBP decreased by 6.59 mmHg (95% confidence interval [CI], -10.71 to -2.47; P=0.0025), from 147.5 to 140.9 mmHg. Mean DBP decreased by 2.85 mmHg (95% CI, -5.53 to -0.16; P=0.038), from 88.9 to 86.1 mmHg. No statistically significant within-participant changes were detected in estimated salt intake, body weight, body mass index, waist circumference, HDL cholesterol, LDL cholesterol, or triglycerides.
Results date posted
| 2026 | Year | 10 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This was a single-arm, before-and-after evaluation of a workplace lifestyle-guidance program conducted among municipal employees in Kamaishi City, Iwate Prefecture, Japan. At the 2024 workplace health checkup, 479 employees were examined, of whom 144 had systolic BP (SBP) >=140 mmHg and/or diastolic BP (DBP) >=90 mmHg. Thirty-nine employees with elevated screening BP consented to participate. Baseline checkup measurements were obtained in 2024 and follow-up measurements at the subsequent annual checkup in 2025.
The present study was a subsequent workplace intervention, distinct from the earlier randomized pilot trial conducted at the same institution.
Participant flow
All 39 participants were provided with a Bluetooth-enabled upper-arm BP monitor (HEM-7281T, Omron Healthcare Co., Ltd., Japan) and the compatible smartphone application (OMRON connect). Participants were instructed to measure home BP on morning and bedtime occasions over at least seven days and to submit their mean home BP, body weight, and lifestyle information through a web-based form.
Individual cardiovascular risk was assessed from home BP and the annual workplace checkup findings in accordance with the Japanese Society of Hypertension Guidelines for the Management of Hypertension 2019 (JSH2019), which were in use when the
Risk-tailored lifestyle guidance and reassessment
Participants judged to be at high cardiovascular risk were offered an individualized in-person counseling session. Those judged to be at low or moderate risk were provided with an individualized written lifestyle-guidance document rather than a routine face-to-face session. Participants who requested in-person counseling received it regardless of their risk classification. Counseling and written materials were tailored to individual home BP, workplace checkup results, body weight, and lifestyle information and addressed salt reduction, alcohol moderation, weight control, smoking cessation, and physical activity.
Approximately three months after initial assessment, participants were asked to repeat at least seven days of home BP monitoring and report updated home BP, body weight, and lifestyle information through the web-based form. Guidance was then repeated or revised using the updated information: high-risk participants and those requesting face-to-face advice received counseling, whereas others were provided with individualized written guidance. Referral or continuation of medical care was recommended when indicated by BP status or cardiovascular risk. In-person consultations usually lasted approximately 20 minutes according to routine practice, but their duration was not systematically recorded. Accordingly, counseling time and resource use were not analyzed as measured outcomes.
For analysis, participants were categorized retrospectively according to the guidance actually received: the in-person counseling group included anyone who attended at least one counseling session at the initial or follow-up assessment; the written-guidance-only group included those who did not receive an in-person session. These were nonrandomized, exposure-defined subgroups, not protocol-assigned comparison arms.
Adverse events
No adverse events
Outcome measures
The principal outcome analyzed was within-person change in SBP from the 2024 to the 2025 annual workplace health checkup. Other checkup measures were DBP, estimated daily salt intake, body weight, body mass index, waist circumference, glycated hemoglobin (HbA1c), high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglycerides. Secondary descriptive outcomes included changes in antihypertensive, antidiabetic, and lipid-lowering medication use and smoking status and changes in self-reported mean home SBP and DBP between the initial and approximately three-month reassessment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2026 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 27 | Day |
Last modified on
| 2026 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071790
