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

NCT07887542 | Completed

• 1 other identifier: 111-006-F
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Home blood pressure monitoring; Blood pressure telemonitoring; Case management; Antihypertensive medication titration; Ambulatory blood pressure monitoring; Mobile health; Crossover trial

Outcome Measures

Primary Outcomes (6)

• 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.

  Baseline, month 6, month 12

• 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.

  Baseline, month 6, month 12

• 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.

  Baseline, month 6, month 12

• 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.

  Baseline, month 6, month 12

• 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.

  Baseline, month 6, month 12

• 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.

  Baseline, month 6, month 12

Secondary Outcomes (9)

• Brachial-Ankle Pulse Wave Velocity

  Baseline, month 6, month 12

• Number of Participants With Adverse Reactions Leading to Treatment Discontinuation

  Up to month 12

• Urine Albumin-to-Creatinine Ratio

  Baseline, month 6, month 12

• ECG Voltage

  Baseline, month 6, month 12

• Adherence to the Home Blood Pressure Measurement Protocol

  Weekly, from baseline to month 12

Study Arms (2)

Case Management First, Then Passive Review

EXPERIMENTAL

Months 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.

Other: Case-manager surveillance with physician-guided remote titration; Other: Passive data review at clinic visits

Passive Review First, Then Case Management

EXPERIMENTAL

Months 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.

Other: Case-manager surveillance with physician-guided remote titration; Other: Passive data review at clinic visits

Interventions

Passive data review at clinic visits OTHER

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.

Case Management First, Then Passive Review; Passive Review First, Then Case Management

Case-manager surveillance with physician-guided remote titration OTHER

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.

Case Management First, Then Passive Review; Passive Review First, Then Case Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital Hsin-Chu Branch: lead
• Omron Healthcare Co., Ltd.: collaborator

Study Sites (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, 300, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chih-Kuo Lee, MD

  National Taiwan University Hospital Hsin-Chu Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking was not feasible because the intervention involved direct contact with case managers. Participants, case managers, and treating cardiologists were aware of the assigned condition. To limit differences in expectation, the app delivered the same system-generated educational messages and reminders in both conditions. Home and ambulatory blood pressure readings were recorded by the devices and exported electronically.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2023
• First Posted: October 21, 2026
• Study Start: October 6, 2022
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 6 months after publication of the primary results, with no planned end date.
• Access Criteria: Qualified researchers with a methodologically sound proposal approved by the principal investigator and the relevant ethics committee. Requests should be directed to the principal investigator.

Locations

TW (1)