JRCT ID: jRCT1040250109
Registered date:07/10/2025
A Study of the Personal Health Record Application for Self-Management of Hypertension Detected at Health Screening
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Hypertension |
| Date of first enrollment | 07/10/2025 |
| Target sample size | 70 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | self-management through a dedicated smartphone app |
Outcome(s)
| Primary Outcome | Mean change in systolic blood pressure (SBP) at 24-hour ambulatory blood pressure monitoring (ABPM) at 12 weeks |
|---|---|
| Secondary Outcome | 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 |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1. Age 18 years or older 2. Blood pressure measured at physical examination or in the examination room: SBP140-179 and/or DBP90-109 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 |
| Exclude 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 Those who have withdrawn their consent to the installation of this application, the terms of use, and the consent form. 4.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. |
Related Information
| Primary Sponsor | Dohi Kaoru |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Ito Hiromasa |
| Address | Edobashi 2-174, Tsu, Mie, Japan Mie Japan 514-8507 |
| Telephone | +81-59-231-5015 |
| h-ito@med.mie-u.ac.jp | |
| Affiliation | Mie University Hospital |
| Scientific contact | |
| Name | Kaoru Dohi |
| Address | Edobashi 2-174, Tsu, Mie, Japan Mie Japan 514-8507 |
| Telephone | +81-59-231-5015 |
| dohik@med.mie-u.ac.jp | |
| Affiliation | Mie University Graduate School of Medicine |