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Effect of home and remote blood pressure monitoring via home BP monitoring system (HMS) on adults with hypertension in taiwan: randomized clinical trial

NCT ID NCT07887542

NEW Sponsor: National Taiwan University Hospital Hsin-Chu Branch Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 21, 2026 · Last updated Oct 21, 2026

Summary

The goal of this clinical trial is to learn whether adding case-manager support to app-connected home blood pressure monitoring improves blood pressure control in adults with hypertension. The main questions it aims to answer are: * Does case-manager surveillance with physician-guided medication adjustment lower office, home, and 24-hour ambulatory blood pressure more than home monitoring with review of readings only at clinic visits? * Does it change how consistently participants measure their blood pressure at home, how their blood pressure medicines are adjusted, and how often side effects are reported? All participants received the same Bluetooth upper-arm blood pressure monitor linked to a smartphone app (OMRON Home BP Monitoring System, HMS). They measured their blood pressure at home in the first week of every month, following the Taiwan "722" schedule: 7 consecutive days, morning and evening, 2 readings each time. Each participant spent 6 months in each of two conditions, in a randomly assigned order: * Case-manager period: case managers reviewed the home readings every month, contacted participants, and arranged earlier clinic visits for medication adjustment when readings met predefined criteria. * Control period: home readings were stored and reviewed by the cardiologist only at scheduled clinic visits. Participants attended clinic visits at the start of the study and at 3, 6, 9, and 12 months.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

211 people

The number who actually took part.

Started

Oct 2022

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Willing to provide written informed consent. * Age 18 years or older. Age 18 years or older. (Participants enrolled before approval of protocol version 4 in February 2023 were required to be 20 to 80 years old.) * Patients receiving antihypertensive medication who have not achieved the treatment target of office blood pressure \<130/80 mmHg, or patients with newly diagnosed hypertension with office systolic blood pressure of 140-180 mmHg and diastolic blood pressure of 90-110 mmHg (or 24-hour ambulatory blood pressure \>130/80 mmHg). Exclusion Criteria: * End-stage, incurable disease with life expectancy of less than one year. * Women who are pregnant, may be pregnant, or are breastfeeding. * Dementia or loss of most self-care ability (ECOG performance status 2 or above). * Office blood pressure \>180/110 mmHg. * Documented cardiac arrhythmia. * Diagnosed secondary hypertension. * Inability to use a smartphone. * Acute cardiovascular event within the past six months, including stroke, decompensated heart failure, percutaneous coronary intervention, or coronary artery bypass graft surgery.

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Conditions

The condition(s) this trial relates to.

hypertensive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension

Contacts and locations

Locations

  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu, 300, Taiwan

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