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HypertensionNCT07887542

Effect of Home and Remote Blood Pressure Monitoring Via Home BP Monitoring System (HMS) on Adults With Hypertension in Taiwan

A study testing Case-manager surveillance with physician-guided remote titration and Passive data review at clinic visits in people with Hypertension, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Case-manager surveillance with physician-guided remote titration and Passive data review at clinic visits
Could I receive a placebo?
No, everyone receives an active treatment
How many people
211 participants
Where
1 siteTaiwan
Study dates
6 Oct 2022to 21 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital Hsin-Chu Branch

    Hsinchu, 300

Other trials in Taiwan

About this study

Official title: Effect of Home and Remote Blood Pressure Monitoring Via Home BP Monitoring System (HMS) on Adults With Hypertension in Taiwan: Randomized Clinical Trial

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:

Read more
  • 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.

Read the detailed description

Design and setting:

This is a single-center, open-label, randomized, two-period, two-sequence crossover trial conducted at the cardiology outpatient clinics of National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan. Participants were randomized 1:1 to receive the case-manager intervention for months 0-6 followed by the control condition for months 6-12, or the reverse order. Crossover occurred at 6 months without a washout period.

Home monitoring common to both conditions:

At enrollment, every participant received an upper-arm Bluetooth blood pressure monitor (OMRON HEM-7157T) paired with the HMS smartphone application. The application transmitted every reading automatically, provided a log for medication intake and side effects, and delivered the same system-generated educational messages and reminders in both conditions. Participants were trained to follow the Taiwan 722 home blood pressure protocol in the first week of each month; measurement at other times was allowed.

Intervention condition (case-manager surveillance with physician-guided remote titration):

Cardiovascular case managers reviewed the transmitted readings at the beginning of each month against two targets: home blood pressure below 130/80 mmHg and self-reported medication adherence on more than 50% of days. A predefined algorithm specified: telephone counseling when participants measured on fewer than 4 days, reported adherence below 50%, or reported side effects; a clinic visit within 2 weeks for home blood pressure above 180/110 mmHg; doubling of the current dose or addition of a drug class when home blood pressure exceeded 135/85 or 145/90 mmHg, respectively, for 2 consecutive months; a change in dosing time or frequency for morning-only or evening-only elevation; and withdrawal of a drug class for home systolic blood pressure below 110 mmHg. All prescription changes were made by the cardiologist at a clinic visit, scheduled earlier when the algorithm required it, and recorded in the medical record.

Control condition (passive data review):

Readings were stored but not reviewed between visits. At each scheduled clinic visit, the treating cardiologist received a summary of the home readings from the preceding 2 weeks and adjusted treatment at his or her discretion.

Assessments:

Office blood pressure was measured at enrollment and at 3, 6, 9, and 12 months. 24-hour ambulatory blood pressure monitoring, brachial-ankle pulse wave velocity, and blood and urine tests were performed at enrollment and at approximately 6 and 12 months. Medication changes, side-effect reports, and health care use were recorded throughout.

Analysis:

Treatment effects are estimated as the 6-month (period 1) difference between randomized sequences, adjusted for baseline values, and as the within-participant crossover treatment effect using the 6- and 12-month values. The sequence effect is examined as an indicator of carryover.

This trial was registered retrospectively, after enrollment was completed.

Conditions
Hypertension
Being tested
Case-manager surveillance with physician-guided remote titration, Passive data review at clinic visits
Keywords
Home blood pressure monitoring, Blood pressure telemonitoring, Case management, Antihypertensive medication titration, Ambulatory blood pressure monitoring, Mobile health, Crossover trial
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Case-manager surveillance with physician-guided remote titrationOther

    Participants measure home blood pressure with an OMRON HEM-7157T Bluetooth monitor linked to the Home BP Monitoring System (HMS) app, following the Taiwan 722 protocol in the first week of each month. Case managers review the transmitted readings monthly against targets of home BP <130/80 mmHg and medication adherence >50% of days. A predefined algorithm guides telephone counseling (fewer than 4 measurement days, adherence <50%, or side effects), a clinic visit within 2 weeks (home BP >180/110 mmHg), dose doubling or addition of a drug class (home BP >135/85 or >145/90 mmHg for 2 consecutive months), dosing time or frequency changes (morning-only or evening-only elevation), and drug withdrawal (home systolic BP <110 mmHg). All prescription changes are made by the cardiologist at a clinic visit, scheduled earlier when needed.

  • Passive data review at clinic visitsOther

    Participants use the same monitor and app and follow the same 722 measurement protocol. Readings are stored but not reviewed between visits, and no case-manager contact is provided. At each scheduled clinic visit, the treating cardiologist receives a summary of the home readings from the preceding 2 weeks and adjusts treatment at his or her discretion. The app delivers the same system-generated education messages and reminders as in the intervention period.

Study groups in NCT07887542
Study groupRoleWhat they receive
Case Management First, Then Passive ReviewExperimentalMonths 0-6: case-manager surveillance with physician-guided remote titration. Months 6-12: passive review of home readings at clinic visits. Crossover at month 6 without a washout period. The same app-connected home blood pressure monitor was used throughout.
Receives: Other: Case-manager surveillance with physician-guided remote titration; Other: Passive data review at clinic visits
Passive Review First, Then Case ManagementExperimentalMonths 0-6: passive review of home readings at clinic visits. Months 6-12: case-manager surveillance with physician-guided remote titration. Crossover at month 6 without a washout period. The same app-connected home blood pressure monitor was used throughout.
Receives: Other: Case-manager surveillance with physician-guided remote titration; Other: Passive data review at clinic visits

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Office Systolic Blood Pressure

    Office systolic blood pressure (mmHg) measured at the clinic visit, compared between the case-manager surveillance and passive data review conditions of the crossover design.

    Measured: Baseline, month 6, month 12

  2. Office Diastolic Blood Pressure

    Office diastolic blood pressure (mmHg) measured at the clinic visit, compared between the case-manager surveillance and passive data review conditions of the crossover design.

    Measured: Baseline, month 6, month 12

  3. Home Systolic Blood Pressure

    Mean home systolic blood pressure (mmHg), measured with the Omron HEM-7157T according to the 722 protocol: on 7 consecutive days at the start of each month, 2 sessions per day (morning and evening), 2 readings per session. Values are compared between the case-manager surveillance and passive data review conditions of the crossover design.

    Measured: Baseline, month 6, month 12

  4. Home Diastolic Blood Pressure

    Mean home diastolic blood pressure (mmHg) measured with the Omron HEM-7157T according to the 722 protocol (7 consecutive days at the start of each month, morning and evening, 2 readings per session), compared between the case-manager surveillance and passive data review conditions of the crossover design.

    Measured: Baseline, month 6, month 12

  5. 24-Hour Mean Systolic Blood Pressure

    Mean 24-hour systolic blood pressure (mmHg) on ambulatory blood pressure monitoring, compared between the case-manager surveillance and passive data review conditions of the crossover design.

    Measured: Baseline, month 6, month 12

  6. 24-Hour Mean Diastolic Blood Pressure

    Mean 24-hour diastolic blood pressure (mmHg) on ambulatory blood pressure monitoring, compared between the case-manager surveillance and passive data review conditions of the crossover design.

    Measured: Baseline, month 6, month 12

Secondary outcomes (9)
  1. Brachial-Ankle Pulse Wave Velocity

    Brachial-ankle pulse wave velocity (m/s), measured with an automated oscillometric device, as a measure of arterial stiffness (target-organ damage).

    Measured: Baseline, month 6, month 12

  2. Number of Participants With Adverse Reactions Leading to Treatment Discontinuation

    Participants with adverse reactions to antihypertensive treatment that led to discontinuation of a medication, recorded in the app or at clinic visits.

    Measured: Up to month 12

  3. Urine Albumin-to-Creatinine Ratio

    Urine albumin-to-creatinine ratio (mg/g), as a measure of microalbuminuria (target-organ damage).

    Measured: Baseline, month 6, month 12

  4. ECG Voltage

    Sokolow-Lyon voltage (SV1 + RV5 or RV6, mV) on 12-lead ECG, as a measure of left ventricular hypertrophy (target-organ damage).

    Measured: Baseline, month 6, month 12

  5. Adherence to the Home Blood Pressure Measurement Protocol

    Percentage of days per week on which both the morning and evening measurement sessions were completed, calculated from readings transmitted by the app.

    Measured: Weekly, from baseline to month 12

  6. Retinal Nerve Fiber Layer Thickness

    Average retinal nerve fiber layer thickness (µm) measured by optical coherence tomography, as a measure of retinal microvascular damage.

    Measured: Baseline

  7. Number of Cardiology Clinic Visits

    Number of cardiology outpatient visits per participant, from hospital records.

    Measured: Months 0-6 and months 6-12

  8. Number of Emergency Department Visits

    Number of emergency department visits per participant, from hospital records.

    Measured: Months 0-6 and months 6-12

  9. Number of Hospital Admissions

    Number of hospital admissions per participant, from hospital records.

    Measured: Months 0-6 and months 6-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2026
  2. Study start6 Oct 2022
  3. Primary completion21 Oct 2025
  4. Study completion21 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Randomized, open-label, two-period, two-sequence crossover design. All participants used the same app-connected home blood pressure monitor throughout. Participants were randomized 1:1 to case-manager surveillance with physician-guided remote titration for months 0-6 followed by passive review of home readings at clinic visits for months 6-12, or the reverse order. Crossover occurred at month 6 without a washout period. Assessments were performed at baseline and at months 3, 6, 9, and 12.
Masking
None (open label)
Enrolment
211 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07887542
Sponsor's protocol ID
111-006-F
Status last verified
Oct 2026
First submitted
27 Aug 2023
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the published results (office, home, and ambulatory blood pressure, medication changes, and side-effect reports) will be available on reasonable request to the principal investigator, after approval of a research proposal and subject to approval by the Research Ethics Committee of National Taiwan University Hospital Hsin-Chu Branch and a data use agreement.

Questions about this trial

What is this clinical trial studying?

A study testing Case-manager surveillance with physician-guided remote titration and Passive data review at clinic visits in people with Hypertension, run by National Taiwan University Hospital Hsin-Chu Branch at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Office Systolic Blood Pressure (time frame: Baseline, month 6, month 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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