An interventional study of Case-manager surveillance with physician-guided remote titration and Passive data review at clinic visits in Hypertension, sponsored by National Taiwan University Hospital Hsin-Chu Branch. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by National Taiwan University Hospital Hsin-Chu Branch · Not applicable, Interventional, and Health services research
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:
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:
Participants attended clinic visits at the start of the study and at 3, 6, 9, and 12 months.
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.
6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.
This study's enrollment of 211 is above the median of 90 across 5,095 interventional studies indexed under Hypertension.
Browse Hypertension studies →National Taiwan University Hospital Hsin-Chu Branch is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, month 6, month 12
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).
Time frame: Baseline, month 6, month 12
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.
Time frame: Up to month 12
Urine Albumin-to-Creatinine Ratio
Urine albumin-to-creatinine ratio (mg/g), as a measure of microalbuminuria (target-organ damage).
Time frame: Baseline, month 6, month 12
ECG Voltage
Sokolow-Lyon voltage (SV1 + RV5 or RV6, mV) on 12-lead ECG, as a measure of left ventricular hypertrophy (target-organ damage).
Time frame: Baseline, month 6, month 12
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.
Time frame: Weekly, from baseline to month 12
Retinal Nerve Fiber Layer Thickness
Average retinal nerve fiber layer thickness (µm) measured by optical coherence tomography, as a measure of retinal microvascular damage.
Time frame: Baseline
Number of Cardiology Clinic Visits
Number of cardiology outpatient visits per participant, from hospital records.
Time frame: Months 0-6 and months 6-12
Number of Emergency Department Visits
Number of emergency department visits per participant, from hospital records.
Time frame: Months 0-6 and months 6-12
Number of Hospital Admissions
Number of hospital admissions per participant, from hospital records.
Time frame: Months 0-6 and months 6-12
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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National Taiwan University Hospital Hsin-Chu Branch