UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039238 |
|---|---|
| Receipt number | R000044740 |
| Scientific Title | Assessment of potential end-organ damage risk by home sleep blood pressure monitoring and its feasibility assessment for clinical use. |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2023/01/24 10:01:27 |
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Basic information
Public title
Availability of home sleep blood pressure monitoring
Acronym
Home sleep blood pressure monitoring study
Scientific Title
Assessment of potential end-organ damage risk by home sleep blood pressure monitoring and its feasibility assessment for clinical use.
Scientific Title:Acronym
Availability of home sleep blood pressure monitoring
Region
| Japan |
Condition
Condition
Essential hypertension
Atrial fibrillation
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sleep blood pressure (BP) is a known risk factor for cardiovascular outcomes independent of clinic BP. However, because sleep BP measurement usually requires a specific device and is burdensome, sleep BP is not always applied in clinical setting and community health practice. Recently, it was clarified that sleep BP could be accurately and easily measurable using a timer-equipped home BP monitor. Here, we aimed to clarify availability of sleep BP measured at home and then corrected via internet in the following three test cases.
In brief, in the community-based study, we will lend the BP monitor to community residents who showed high BP at the health check-ups of the community. Health nurses uses sleep and home BP values in their health guidance for the residents, and then evaluate the availability of home sleep BP monitoring in community health promotion. In the general practitioner-based study, physicians will lend the BP monitor to their patients with hypertension. Physicians use home and sleep BP values to identify individuals with potentially high BP who cannot be identified only clinic BP monitoring. The findings will be used to decide therapeutic strategy in usual BP treatment. In the third study in patients with atrial fibrillation, BP and pulse rate during sleep will be used as a reference value for heat rate control during sleep. Physicians evaluate whether the values measured during sleep is informative for clinical care. We also perform community-based cohort study to clarify factors associated with sleep BP. Results from the epidemiological study may be useful for further understanding of factors for sleep BP and pulse rate, and thus help use sleep BP and pulse rate in clinical setting.
Results of present study may emphasize an importance of home sleep BP monitoring and provide evidence to use sleep BP in clinical setting and community health promotion.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
health behavior modification by home blood pressure monitoring
Key secondary outcomes
availability for blood pressure management
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 monitoring
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients of hypertension or atrial fibrillation who are considered as appropriate for this study by physicians or public health nurses.
Key exclusion criteria
Patients who are considered as not appropriate for this study by physicians or public health nurses
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | tabara |
| Middle name | |
| Last name | yasuharu |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
606-8507
Address
Shogoinkawara-cho 53, Sakyo-ku, Kyoto
TEL
075-751-4157
tabara@genome.med.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | tabara |
| Middle name | |
| Last name | yasuharu |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
606-8507
Address
Shogoinkawara-cho 53, Sakyo-ku, Kyoto
TEL
075-751-4157
Homepage URL
tabara@genome.med.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
AMED
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
Kyoto University
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2020 | Year | 04 | Month | 01 | 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
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044740
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
