臨床研究等提出・公開システム

A Randomized Controlled Trial Evaluating the Effectiveness of Stepwise Reminder Interventions Using a Self-Management-Supported PHR Application among Corporate Employees (STEP-UP trial)

A Randomized Controlled Trial to Evaluate the Efficacy of a PHR App for Self-Management Support and a Stapwise Reminder Interventions (STEP-UP trial)

Dohi Kaoru

Mie University Graduate School of Medicine

Edobashi 2-174, Tsu, Mie, Japan

dohik@med.mie-u.ac.jp

Ito Hiromasa

Mie University Hospital

Edobashi 2-174, Tsu, Mie, Japan

+81-59-231-5015

h-ito@med.mie-u.ac.jp

Recruiting

May. 13, 2026

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

health services research

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

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2) Individuals who have withdrawn their consent to install this app or to the Terms of Use and Consent Form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

Both

Hypertension

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

Hypertension, Lifestyle-related disease, Metabolic syndrome

PHR application, remind, support, monitoring

D006973

D010548

Average change in systolic blood pressure at 12 weeks (office blood pressure and home blood pressure)

+81-59-231-5045

May. 08, 2026

No

none