UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061573 |
|---|---|
| Receipt number | R000069751 |
| Scientific Title | Balancing Disease Management and Social Life Achieving Work-Life Support and Health-Oriented Management :A Collaborative Model Between Healthcare Providers and Companies for Early Care of Hypertension and Cardiovascular Diseases |
| Date of disclosure of the study information | 2026/05/14 |
| Last modified on | 2026/05/14 17:27:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Balancing Disease Management and Social Life
Achieving Work-Life Support and Health-Oriented Management
:A Collaborative Model Between Healthcare Providers and Companies for Early Care of Hypertension and Cardiovascular Diseases
Acronym
Balancing Disease Management and Social Life
Achieving Work-Life Support and Health-Oriented Management
:A Collaborative Model Between Healthcare Providers and Companies for Early Care of Hypertension and Cardiovascular Diseases
Scientific Title
Balancing Disease Management and Social Life
Achieving Work-Life Support and Health-Oriented Management
:A Collaborative Model Between Healthcare Providers and Companies for Early Care of Hypertension and Cardiovascular Diseases
Scientific Title:Acronym
Balancing Disease Management and Social Life
Achieving Work-Life Support and Health-Oriented Management
:A Collaborative Model Between Healthcare Providers and Companies for Early Care of Hypertension and Cardiovascular Diseases
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Achieving Work-Life Balance Support and Corporate Health Management
Through Collaborative Interventions by Occupational Physicians and Cardiovascular Specialists
to Prevent the Progression of Hypertension
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood pressure levels
Key secondary outcomes
Behavioral changes related to self-management of blood pressure control
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Education on hypertension and guidance on self-monitoring,along with alerts for severe(grade3) hypertension
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Systolic blood pressure of 140 mmHg or higher, or diastolic blood pressure of 90 mmHg
Key exclusion criteria
Mental disorders
Seizure episodes and paroxysmal disorders
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yukiko |
| Middle name | |
| Last name | Nakano |
Organization
Hiroshima University Hospital
Division name
Department of Cardiocascular Medicine
Zip code
7348551
Address
1-2-3 Kasumi,Minami-ku.Hiroshima city
TEL
0822575555
nakanoy@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kana |
| Middle name | |
| Last name | Kanai |
Organization
Hiroshima University Hospital
Division name
Department of rehabilitation
Zip code
7348551
Address
1-2-3 Kasumi,Minami-ku.Hiroshima city
TEL
0822575555
Homepage URL
kanakanai@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
Kasumi 1-2-3 Minami-Ku, Hiroshima
Tel
082-257-1947
iryo-sinsa@office.hiroshima-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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 14 | 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
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069751
