JRCT ID: jRCT1040260027
Registered date:13/05/2026
A Randomized Controlled Trial to Evaluate the Efficacy of a PHR App for Self-Management Support and a Stapwise Reminder Interventions
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Hypertension |
| Date of first enrollment | 13/05/2026 |
| Target sample size | 100 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | If any of the following conditions are met, the HR representative will send a notification to the employee via internal email or personal email in a phased manner, recommending that they enter their data or undergo a medical examination. Condition 1: If measurements or records are missing Step 1: No measurements or records for 3 consecutive days Step 2: No measurements or records for 7 consecutive days Step 3: No measurements or records for 14 consecutive days Condition 2: When a high blood pressure alert appears (*) Step 1: If the employee has not sought medical attention or consulted a healthcare professional, or has not responded Step 2: If the employee has not sought medical attention or consulted a healthcare professional even after receiving a reminder in Step 1 Step 3: If the employee has not sought medical attention or consulted a healthcare professional even after receiving a reminder in Step 2 |
Outcome(s)
| Primary Outcome | Average change in systolic blood pressure at 12 weeks (office blood pressure and home blood pressure) |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | 1) Aged 18 or older 2) An employee of a participating research institution (including part-time and temporary staff) 3) Has high blood pressure or is classified as having hypertension (including those diagnosed by a medical institution within the past five years) 4) Owns a smartphone capable of connecting to the internet and installing this app 5) Is able to measure blood pressure at home |
| Exclude criteria | 1) Individuals who are unable to use a smartphone due to cognitive or physical impairment or disability 2) Individuals who have withdrawn their consent to install this app or to the Terms of Use and Consent Form 3) Individuals whom the principal investigator or a co-investigator deems unsuitable for inclusion in the study 4) Individuals who are participating in, or are scheduled to participate in, another clinical study that is likely to affect the treatment of their hypertension while participating in this study 5) Individuals with severe hypertension (equivalent to Stage III hypertension) or in a condition requiring urgent blood pressure reduction, where the principal investigator or occupational physician determines that participation in the study would be detrimental to the individual |
Related Information
| Primary Sponsor | Dohi Kaoru |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Agency for Medical Research and Development |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Hiromasa Ito |
| 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 |