UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030949 |
|---|---|
| Receipt number | R000035274 |
| Scientific Title | Investigation of the effect on blood pressure improvement by home blood pressure, steps, and sleep time measurement |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/07/25 09:05:59 |
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Basic information
Public title
Investigation of the effect on blood pressure improvement by home blood pressure, steps, and sleep time measurement
Acronym
Investigation of the effect on blood pressure improvement by home blood pressure, steps, and sleep time measurement
Scientific Title
Investigation of the effect on blood pressure improvement by home blood pressure, steps, and sleep time measurement
Scientific Title:Acronym
Investigation of the effect on blood pressure improvement by home blood pressure, steps, and sleep time measurement
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect on blood pressure improvement by blood pressure, steps, and sleep time measurements.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in average systolic blood pressure
Key secondary outcomes
1) Change in average diastolic blood pressure
2) Change in average weight
3) Change in average steps
4) Change in average sleep time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
blood pressure measurement every morning and evening only for 2 days (first day and 60 days later)
Interventions/Control_2
blood pressure measurement every morning and evening for 60 days
Interventions/Control_3
blood pressure measurement every morning and evening every day, weight measurement, and sleep time measurement with a wearable device for 60 days
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. People who have 130-179 mmHg in systolic blood pressure and/or 85-109 mmHg in diastolic blood pressure
2. People who are 40-64 years old when obtaining informed consent, and are able to give informed consent
Key exclusion criteria
1. People who suffer from any malignant diseases
2. People who have any serious liver/kidney/heart/brain diseases
3. People who are in pregnancy or during lactation
4. People who are judged as inappropriate to be enrolled into this study due to safety by any Sponsor
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Morimoto |
Organization
Panasonic Corporation
Division name
Business Development Center, Appliances Company
Zip code
Address
4F Hamamatsu-Cho Bldg. 1-17-14 Hamamatsu-cho, Minato-ku, Tokyo
TEL
03-6403-3255
morimoto.tak@jp.panasonic.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Morimoto |
Organization
Panasonic Corporation
Division name
Business Development Center, Appliances Company
Zip code
Address
4F Hamamatsu-Cho Bldg. 1-17-14 Hamamatsu-cho, Minato-ku, Tokyo
TEL
03-6403-3255
Homepage URL
morimoto.tak@jp.panasonic.com
Sponsor or person
Institute
Business Development Center, Appliances Company, Panasonic Corporation
Institute
Department
Personal name
Funding Source
Organization
Business Development Center, Appliances Company, Panasonic Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cerebral and Cardiovascular Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 02 | 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
| 2017 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 23 | Day |
Last modified on
| 2018 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035274
| 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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