JMIR Publications

ABSTRACT

Background:

Hypertension affects nearly half of US adults, yet fewer than one in four achieves adequate blood pressure (BP) control. Traditional outpatient management is limited by infrequent visits and episodic BP measurement, contributing to therapeutic inertia. Remote patient monitoring (RPM) enables home-based BP tracking but can overwhelm clinicians with unstructured data, exacerbating administrative burden. Guideline-integrated decision support that automates BP interpretation and generates medication titration recommendations could reduce therapeutic inertia while preserving clinician oversight.

Objective:

This study was conducted to evaluate the feasibility, acceptability, and preliminary effectiveness of the HrtEx hypertension management platform in distinct care environments.

Methods:

We conducted two prospective single-arm pilot studies of HrtEx, a clinician-facing digital decision support platform that converts home BP data into guideline-concordant medication titration recommendations. The first pilot (HrtEx 1.0; n=18) was conducted at an urban academic medical center; the second (HrtEx 2.0; 19 enrolled, 15 analyzed) at a rural cardiology clinic. Adults with essential hypertension (BP >130/80 mmHg) treated with 2 or fewer antihypertensive medications measured home BP daily using Bluetooth-enabled cuffs with automated transmission. BP values were averaged over 2-week intervals; sustained elevations triggered guideline-based titration recommendations that clinicians could accept or decline. The primary outcome was 12-week change in systolic and diastolic BP; clinician acceptance rate of algorithm-generated recommendations was assessed as a secondary outcome in HrtEx 2.0.

Results:

In the academic pilot, mean systolic BP (SBP) decreased from 133.1 ± 7.8 to 121.3 mmHg (Δ −11.8 mmHg; 95% CI, 5.8 to 17.9; p<0.001) and mean diastolic BP (DBP) from 87.3 ± 7.1 to 80.2 mmHg (Δ −7.1 mmHg; 95% CI, 3.1 to 11.1; p=0.002). In the rural pilot, among the 15 participants with elevated baseline BP, mean SBP decreased from 133.9 to 124.7 mmHg (Δ −9.2 mmHg; 95% CI, 4.6 to 13.8; p=0.0008; d=1.10) and mean DBP from 79.0 to 76.1 mmHg (Δ −2.9 mmHg; 95% CI, 0.8 to 5.1; p=0.012; d=0.75). In Pilot 2, clinicians accepted 32 of 38 (84%) algorithm-generated titration recommendations, averaging 2.1 accepted adjustments per analyzed patient (32 accepted recommendations across 15 analyzed patients); clinician recommendation tracking was not implemented in Pilot 1. Patient adherence exceeded 89% in both cohorts; 100% of surveyed Pilot 2 participants expressed satisfaction with medication titration timing.

Conclusions:

Across two geographically and demographically distinct single-arm pilot studies, a guideline-integrated RPM decision support platform demonstrated feasibility and was associated with systolic BP reductions of 11.8 mmHg and 9.2 mmHg in academic and rural cohorts, respectively, alongside high clinician acceptance and patient adherence. Given the absence of a comparator arm, these findings are hypothesis-generating and support confirmatory evaluation in randomized controlled trials. Clinical Trial: NCT05479461