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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039238
Receipt No. 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 2020/01/23

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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
Email 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
Email tabara@genome.med.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 01 Day
Date of IRB
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
2020 Year 01 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044740

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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