UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057741 |
|---|---|
| Receipt number | R000065981 |
| Scientific Title | Promoting Habitual Home Blood Pressure Monitoring via Designated Device Placement: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/04/30 |
| Last modified on | 2025/10/31 13:29:35 |
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Basic information
Public title
Promoting Habitual Home Blood Pressure Monitoring via Designated Device Placement: A Randomized Controlled Trial
Acronym
Promoting Habitual Home Blood Pressure Monitoring via Designated Device Placement: A Randomized Controlled Trial
Scientific Title
Promoting Habitual Home Blood Pressure Monitoring via Designated Device Placement: A Randomized Controlled Trial
Scientific Title:Acronym
Promoting Habitual Home Blood Pressure Monitoring via Designated Device Placement: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate whether instructing hypertensive patients aged 40 years and older who were eligible for health counseling under a municipal hypertension management program to place their blood pressure monitor in a designated location would promote regular home monitoring and affect the frequency of measurements and blood pressure levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of home blood pressure monitoring
Key secondary outcomes
blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention:Standard health counseling with additional instruction to place the blood pressure monitor in a designated location
Interventions/Control_2
Control:Standard health counseling on home blood pressure monitoring
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among hypertensive patients aged 40 years and older who were eligible for health counseling interviews under a municipal program for the prevention of severe hypertension, those who had performed home blood pressure monitoring on three or fewer days per week during the week prior to the initial counseling session and who provided informed consent to participate in the study were included.
Key exclusion criteria
Participants who had measured their blood pressure on four or more days per week during the week prior to the initial counseling session
Target sample size
198
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Yamamoto |
Organization
The University of Osaka
Division name
Health and Counseling Center
Zip code
560-0043
Address
1-17 Machikaneyama, Toyonaka, Osaka
TEL
06-6850-6015
yamamoto.ryohei.ras@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Yamamoto |
Organization
The University of Osaka
Division name
Health and Counseling Center
Zip code
560-0043
Address
1-17 Machikaneyama, Toyonaka, Osaka
TEL
06-6850-6015
Homepage URL
yamamoto.ryohei.ras@osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Health and Counseling Center, Osaka University
Address
1-17 Machikaneyama, Toyonaka, Osaka
Tel
06-6850-6015
yamamoto.ryohei.ras@osaka-u.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
大阪府寝屋川市健康づくり推進課
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 30 | 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
| 2024 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 04 | Month | 30 | Day |
Last modified on
| 2025 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065981
