UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046279 |
|---|---|
| Receipt number | R000042385 |
| Scientific Title | Implementation of continuous home blood pressure measurement and monitoring of lifestyle in prospective cohort study participants in Tarumizu city |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2023/06/12 19:49:05 |
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Basic information
Public title
Implementation of continuous home blood pressure measurement and monitoring of lifestyle in prospective cohort study participants in Tarumizu city
Acronym
Relationship between home blood pressure measurement and lifestyle, and usefulness of management class for blood pressure
Scientific Title
Implementation of continuous home blood pressure measurement and monitoring of lifestyle in prospective cohort study participants in Tarumizu city
Scientific Title:Acronym
Relationship between home blood pressure measurement and lifestyle, and usefulness of management class for blood pressure
Region
| Japan |
Condition
Condition
adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between home blood pressure and lifestyle, and investigate the usefulness of management class for blood pressure control
Basic objectives2
Others
Basic objectives -Others
To investigate the optimal blood pressure management and prevention of hypertension from the relationship between individual blood pressure and lifestyle
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Home blood pressure measurement: 2 times / day in the morning and night, continuous throughout the period (blood pressure, measurement time, room temperature)
2. Activity: number of steps, activity amount
3. Na/k ratio
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
We conduct management class for blood pressure control on diet and exercise for all participants once every two months.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
General population over 40 years old living in Tarumizu-shi who are participating in cohort study (umin R000042377)
Key exclusion criteria
not applicable
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Ohishi |
Organization
Graduate school of medical and dental sciences, Kagoshima university
Division name
Cardiovascular medicine and hypertension
Zip code
890-8520
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
0992755318
ohishi@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Kubozono |
Organization
Graduate school of medical and dental sciences, Kagoshima university
Division name
Cardiovascular medicine and hypertension
Zip code
890-8520
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
TEL
0992755318
Homepage URL
kubozono@cepp.ne.jp
Sponsor or person
Institute
Department of Cardiovascular medicine and hypertension, Graduate school of medical and dental sciences, Kagoshima university
Institute
Department
Personal name
Funding Source
Organization
OMRON HEALTHCARE Co.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional ethics committees of the Graduate School of Medical and Dental Sciences, Kagoshima University
Address
8-35-1, Sakuragaoka, Kagoshima, Japan
Tel
0992756090
jpisgskkrs@kuas.kagoshima-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 30 | 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
| 2021 | Year | 12 | Month | 04 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042385
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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