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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036615
Receipt No. R000039811
Scientific Title Utility of wearable device in wrist-based blood pressure monitoring in the frequency of blood pressure measurement and the change in health consciousness: a randomized controlled trial
Date of disclosure of the study information 2019/04/26
Last modified on 2019/05/20

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Basic information
Public title Utility of wearable device in wrist-based blood pressure monitoring in the frequency of blood pressure measurement and the change in health consciousness: a randomized controlled trial
Acronym Utility of wearable device in wrist-based blood pressure monitoring
Scientific Title Utility of wearable device in wrist-based blood pressure monitoring in the frequency of blood pressure measurement and the change in health consciousness: a randomized controlled trial
Scientific Title:Acronym Utility of wearable device in wrist-based blood pressure monitoring
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By using a wearable wrist sphygmomanometer for measuring blood pressure at home, we examine whether it is possible to measure blood pressure at the instructed timing, to increase the number of times of measuring blood pressure or to change in behavior, as compared with a conventionally marketed wrist sphygmomanometer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total number of blood pressure measurement opportunities for 14 days
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Maneuver
Interventions/Control_1 Wearable wrist sphygmomanometer
Interventions/Control_2 Conventional wrist sphygmomanometer
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 Patients who have a blood pressure of 140/90 mmHg or more twice in a row continuously based on Hypertension treatment guidelines 2014 by the Japan Hypertension Society, or who are performing hypertension treatment (diet therapy, exercise therapy and antihypertensive medication)

Person using smartphone
Key exclusion criteria Shift workers (including night shift and shift work)
Medical national qualification person
Wrist circumference is less than 15 cm, 20.5 cm or more (because the wrist sphygmomanometer can not be attached)
Shunt for hemodialysis in the forearm or wrist
Dementia
Upper limb paralysis
Rubber or metal allergy
Easily bleed internally
Trauma and inflammation on the wrist
Person who judged as an inappropriate subject by examination chief doctor
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Taku
Middle name
Last name Iwami
Organization Kyoto University
Division name Agency for Health, Safety and Environment
Zip code 606-8501
Address Yoshida-honmachi, Sakyo-ku, Kyoto
TEL 075-753-2435
Email ketsuatsu_rct2018@hoken.kyoto-u.ac

Public contact
Name of contact person
1st name Takuya
Middle name
Last name Taniguchi
Organization Kyoto University
Division name Agency for Health, Safety and Environment
Zip code 606-8501
Address Yoshida-honmachi, Sakyo-ku, Kyoto
TEL 075-753-2433
Homepage URL
Email ketsuatsu_rct2018@hoken.kyoto-u.ac

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Omron Healthcare
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address Yoshida-konoe-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
2019 Year 04 Month 26 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
2019 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2019 Year 05 Month 07 Day
Last follow-up date
2020 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
2019 Year 04 Month 26 Day
Last modified on
2019 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039811

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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