UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058382 |
|---|---|
| Receipt number | R000066748 |
| Scientific Title | An Exploratory Study of the Personal Health Record Application for Self-Management of Hypertension Detected at Health Screening |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/07 10:42:56 |
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Basic information
Public title
An Exploratory Study of the Personal Health Record Application for Self-Management of Hypertension Detected at Health Screening
Acronym
Ex-SMART trial
Scientific Title
An Exploratory Study of the Personal Health Record Application for Self-Management of Hypertension Detected at Health Screening
Scientific Title:Acronym
Ex-SMART trial
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to introduce a lifestyle-related disease (hypertension) management application to subjects who have been found to have hypertension during health screenings, and to examine the effects of the application on the subjects' daily vital signs such as blood pressure, pulse rate, and weight, responses to a lifestyle-related self-check, and daily symptoms.The purpose of this study is to test whether a system that promotes awareness and behavioral change through the use of patient-reported outcome (PRO) and learning content is useful in the management of hypertension by comparing the traditional paper-based hypertension diary with a randomized trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean change in systolic blood pressure (SBP) at 24-hour ambulatory blood pressure monitoring (ABPM) at 12 weeks
Key secondary outcomes
Mean change in ABPM diastolic blood pressure (DBP), percentage achieving -5 mmHg systolic and diastolic respectively, change in home blood pressure, change in office blood pressure, change in quality of life (QOL), app use/medication adherence rate, change in urinary sodium/potassium ratio
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Intervention group: self-management through a dedicated smartphone app
Interventions/Control_2
Control group: Self-management using conventional blood pressure diary
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 18 years or older
2. Blood pressure measured at physical examination or in the examination room: 140-179/90-109 mmHg
3. SBP 130 mmHg or higher as measured by ABPM
4. Ownership of a smartphone that can be connected to the Internet environment and on which this application can be installed
5. The patient's free and voluntary written consent to participate in this study has been obtained after sufficient informed consent
Key exclusion criteria
1. Those who do not have access to an Internet environment or do not have a smartphone capable of installing this application
2. Those who are unable to use a smartphone due to cognitive or physical decline or disability
3. Those who have withdrawn their consent to the installation of this application, the terms of use, and the consent form.
4. Those whose inclusion in the study is deemed inappropriate by the principal investigator or co-investigator
5. Those who are participating in other clinical studies that may affect the treatment of hypertension, or who are scheduled to participate in this study while participating in this study.
6. Patients with marked hypertension (equivalent to degree III hypertension) or those in need of emergency antihypertensive treatment.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Dohi |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
514-8503
Address
Edobashi 2-174, Tsu, Mie, Japan
TEL
059-231-5015
dohik@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | ito |
Organization
Mie University Hospital
Division name
Depatment of Cardiology
Zip code
514-8507
Address
Edobashi 2-174, Tsu, Mie, Japan
TEL
059-231-5015
Homepage URL
h-ito@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Clinical Research Ethics Review Committiee of Mie University Hospital
Address
Edobashi 2-174, Tsu, Mie, Japan
Tel
059-231-5246
kk-sien@med.mie-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 | 07 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 10 | 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 | 07 | Day |
Last modified on
| 2025 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066748
