UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060224 |
|---|---|
| Receipt number | R000068768 |
| Scientific Title | Home Blood Pressure Monitoring Using a Smartphone-Connected Device Combined with Lifestyle Counseling for Workers with Elevated Blood Pressure: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/12/29 |
| Last modified on | 2025/12/28 21:25:06 |
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Basic information
Public title
Effect of Home Blood Pressure Monitoring Using a Smartphone-Connected Device and Lifestyle on Blood Pressure Control
Acronym
SMART-Home BP Study
Scientific Title
Home Blood Pressure Monitoring Using a Smartphone-Connected Device Combined with Lifestyle Counseling for Workers with Elevated Blood Pressure: A Randomized Controlled Trial
Scientific Title:Acronym
SMART-WORK BP Trial
Region
| Japan |
Condition
Condition
Eligible participants are workers who were identified as having elevated blood pressure at routine workplace health checkups
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the effectiveness of smartphone-connected home blood pressure monitoring and guideline-based hypertension management in improving lifestyle behaviors, lowering blood pressure, and increasing antihypertensive medication use among workers with hypertension detected at workplace health checkups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in blood pressure from baseline (pre-intervention workplace health checkup) to the annual workplace health checkup in the year after the intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Workers with a systolic blood pressure of >=140 mmHg and/or a diastolic blood pressure of >=90 mmHg at routine workplace health checkups were allocated to either an intervention group or a control group using stratified randomization based on sex, age, and systolic blood pressure level.
Participants assigned to the intervention group performed home blood pressure monitoring using a smartphone application-connected, communication-enabled blood pressure device twice daily (after waking and before bedtime) for 14 consecutive days, followed by initial lifestyle counseling based on a hypertension management plan using the home blood pressure results; home blood pressure was re-evaluated and additional counseling was provided three months later.
Interventions/Control_2
Participants in the control group did not receive home blood pressure monitoring; instead, they received initial lifestyle counseling based on blood pressure measured at the workplace health checkup according to the hypertension management plan, followed by re-evaluation using casual blood pressure measurement and additional counseling three months later.
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Workers with a systolic blood pressure of >=140 mmHg and/or a diastolic blood pressure of >=90 mmHg identified at routine workplace health checkups.
Key exclusion criteria
Individuals who routinely measure and record home blood pressure
Individuals who are not scheduled to undergo the routine workplace health checkup in the year following the intervention
Individuals for whom blood pressure reduction is medically contraindicated or restricted by a physician
Target sample size
72
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
020-8505
Address
19-1, Uchimaru, Morioka, Iwate
TEL
+81-19-613-6111
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
020-8505
Address
19-1, Uchimaru, Morioka, Iwate
TEL
+81-19-613-6111
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
| 2025 | Year | 12 | Month | 29 | 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
58
Results
In the intervention group, significant reductions were observed in SBP (-7.5 mmHg; 95% CI, 2.0-13.0; p=0.010), DBP (-4.6 mmHg; 95% CI, 0.5-8.6; p=0.028), body weight (-1.2 kg; 95% CI, 0.2-2.2; p=0.021), and HbA1c (-0.1%; 95% CI, 0.02-0.2; p=0.020). No significant changes were observed in the control group. There were no significant between-group differences in waist circumference, lipid profiles, estimated salt intake, or medication use.
Results date posted
| 2025 | Year | 12 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 28 | Day |
Last modified on
| 2025 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068768
