UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058485 |
|---|---|
| Receipt number | R000065555 |
| Scientific Title | Effect of health communication intervention in encouraging untreated hypertension patients to take up the health care program -Verification by a randomized controlled trial- |
| Date of disclosure of the study information | 2025/07/16 |
| Last modified on | 2025/07/16 09:44:35 |
* 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
Effect of health communication intervention in encouraging untreated hypertension patients to take up the health care program
-Verification by a randomized controlled trial-
Acronym
Health communication intervention to encourage hypertensive patients to seek medical help
Scientific Title
Effect of health communication intervention in encouraging untreated hypertension patients to take up the health care program
-Verification by a randomized controlled trial-
Scientific Title:Acronym
Health communication intervention to encourage hypertensive patients to seek medical help
Region
| Japan |
Condition
Condition
hypertension
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Targeting untreated hypertensive people in the prime of their working lives, for whom the onset and aggravation of lifestyle-related diseases is thought to cause great social and family losses and impacts, we will implement a health communication intervention that emphasizes emotional factors in encouraging them to seek medical help, and verify the effect on their actual behavior in seeking medical help.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether or not the patient has visited a doctor
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
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
In addition to the usual recommendation to see a doctor for those who are found to have high blood pressure during a health check, a message is also included to anticipate regret.
Interventions/Control_2
In addition to the usual recommendation to see a doctor for subjects who are found to have high blood pressure during a health check, a message that anticipates positive feelings is also included.
Interventions/Control_3
Subjects who are found to have high blood pressure during a health check will be encouraged to undergo regular medical examinations.
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 40-64 who are considered to be at low to high risk for cerebrovascular disease based on office blood pressure according to the Japan Guidelines for Hypertension 2019. In other words, men and women with blood pressure of 130/80mmHg or higher.
Key exclusion criteria
Those who regularly visit a doctor for high blood pressure, regardless of whether they are taking oral medication or not
Target sample size
183
Research contact person
Name of lead principal investigator
| 1st name | Misa |
| Middle name | |
| Last name | Shiomi |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
606-8507
Address
53, Shogoin Kawaramachi, Sakyo Ward, Kyoto City, Kyoto Prefecture
TEL
075-753-9301
060kensui@mail2.adm.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Saori |
| Middle name | |
| Last name | Fukuda |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
606-8507
Address
53, Shogoin Kawaramachi, Sakyo Ward, Kyoto City, Kyoto Prefecture
TEL
075-753-9301
Homepage URL
saori.fukuda.77a@st.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto 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
Research Promotion Section, General Affairs and Planning Division, Graduate School of Medicine, Kyoto University
Address
Yoshida Konoecho, Sakyo Ward, Kyoto City
Tel
075-753-9301
060kms@mail2.adm.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
| 2025 | Year | 07 | Month | 16 | 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
| 2025 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 07 | Month | 16 | Day |
Last modified on
| 2025 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065555
