UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036615 |
|---|---|
| Receipt number | 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 | 2022/10/12 02:23:04 |
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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
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
ketsuatsu_rct2018@hoken.kyoto-u.ac
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 26 | Day |
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
| 2022 | Year | 09 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 04 | Month | 26 | Day |
Last modified on
| 2022 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039811
| Research Plan | |
|---|---|
| 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 |
