UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055116 |
|---|---|
| Receipt number | R000062967 |
| Scientific Title | Investigation of Blood Pressure Changes in Health Checkup Participants with Focus on the Use of Online Medical Consultations |
| Date of disclosure of the study information | 2024/07/30 |
| Last modified on | 2025/09/12 18:36:18 |
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Basic information
Public title
Investigation of Blood Pressure Changes in Health Checkup Participants with Focus on the Use of Online Medical Consultations
Acronym
Investigation of Blood Pressure Changes in Health Checkup Participants with Focus on the Use of Online Medical Consultations
Scientific Title
Investigation of Blood Pressure Changes in Health Checkup Participants with Focus on the Use of Online Medical Consultations
Scientific Title:Acronym
Investigation of Blood Pressure Changes in Health Checkup Participants with Focus on the Use of Online Medical Consultations
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Among a group determined to be at high risk of future cardiovascular disease based on health checkup results, to compare the blood pressure changes, cardiovascular disease risk, and health checkup outcomes between those who participated in a program to actively use online medical consultations and those who did not
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of individuals who achieved a systolic blood pressure of less than 140 mmHg in the 2023 and 2024 health checkups
Key secondary outcomes
The proportion of individuals who achieved a systolic blood pressure of less than 140 mmHg and a diastolic blood pressure of less than 90 mmHg in the 2023 and 2024 health checkups.
Changes in home blood pressure among the group receiving online medical consultations.
Risk grades for developing one or more of the following five events within the next three years: myocardial infarction, intracerebral hemorrhage, cerebral infarction, aortic aneurysm/dissection, or heart failure.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Participants who have received the 2022 health checkup (reference year checkup) and are enrolled in the Omron Health Insurance Association (excluding family members).
2. Among the individuals from the above health checkup, those who are at high risk of developing one or more of the following five events within the next three years: myocardial infarction, intracerebral hemorrhage, cerebral infarction, aortic aneurysm/dissection, or heart failure (falling into either of the following criteria):
- Those in the top 5% of risk, and with the most recent health checkup results showing "systolic blood pressure of 140 mmHg or higher" or "diastolic blood pressure of 90 mmHg or higher".
- Those in the top 10% of risk, and with the most recent health checkup results showing "systolic blood pressure of 160 mmHg or higher" or "diastolic blood pressure of 100 mmHg or higher.
Key exclusion criteria
Those who have expressed an intention to opt-out
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Junichi |
| Middle name | |
| Last name | Yatabe |
Organization
General Incorporated Association telemedEASE
Division name
Representative Director
Zip code
102-0083
Address
2F Kojimachi New Yahiko Building, 2-30, Kojimachi 6-chome, Chiyoda-ku, Tokyo
TEL
050-3528-8158
supportjyatabe@telemedease.org
Public contact
Name of contact person
| 1st name | Akiyoshi |
| Middle name | |
| Last name | Fujisaki |
Organization
OMRON HEALTHCARE Co., Ltd.
Division name
Technology Development Supervisory Division
Zip code
600-8530
Address
Omron Kyoto Center Building, East of Horikawa, Shio Koji Street, Shimogyo-ku, Kyoto City
TEL
050-1801-5061
Homepage URL
akiyoshi.fujisaki@omron.com
Sponsor or person
Institute
General Incorporated Association telemedEASE
Institute
Department
Personal name
Funding Source
Organization
OMRON HEALTHCARE Co., Ltd.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18 Shirakane, Showa-ku, Nagoya city, Aichi, JAPAN
Tel
0368092722
soumu@hc-sys.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
| 2024 | Year | 07 | Month | 30 | 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
89
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 07 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062967
