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COMPLETED
NCT07887542
NA

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

Sponsor: National Taiwan University Hospital Hsin-Chu Branch

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

211

Start Date

2022-10-06

Completion Date

2025-10-21

Last Updated

2026-10-21

Healthy Volunteers

No

Conditions

Interventions

OTHER

Case-manager surveillance with physician-guided remote titration

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.

OTHER

Passive data review at clinic visits

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.

Locations (1)

National Taiwan University Hospital Hsin-Chu Branch

Hsinchu, Taiwan