JMIR Publications

ABSTRACT

Background:

Hypertension is a leading cardiovascular risk factor, yet only about half of affected individuals achieve blood pressure (BP) control, with persistent disparities among low-income and minority populations. Wireless home BP monitoring (HBPM) integrated with remote patient monitoring shows promise for improving BP management, but evidence is limited in medically underserved, predominantly Hispanic populations served by Federally Qualified Health Centers (FQHCs).

Objective:

The primary objective was to evaluate the feasibility and acceptability of wireless HBPM among predominantly Hispanic adults with hypertension receiving care at FQHCs. Comparison of BP outcomes between wireless and conventional HBPM was a secondary exploratory objective.

Methods:

We conducted a 6-month, two-arm randomized controlled pilot feasibility and acceptability trial nested within the San Diego: Heart Attack and Stroke Free Zone program. Adults aged ≥18 years with uncontrolled or newly diagnosed hypertension (BP ≥140/90 mmHg) were enrolled across three FQHC networks and randomized 1:1 to wireless HBPM (Bluetooth cuff and cellular hub; weekly transmitted summaries reviewed by health coaches) or standard HBPM (home monitor with paper log), using a single a priori allocation sequence generated by spreadsheet random-number function without blocking or stratification. Both arms received standardized health coaching. Primary outcomes were feasibility, measured as the proportion of 210 expected BP readings transmitted, and acceptability, measured by a post-intervention satisfaction survey in the wireless arm. Exploratory analyses compared BP outcomes between arms among participants with at least two clinic BP measurements. The trial was not powered to detect between-arm differences in clinical outcomes.

Results:

Of 316 recruited participants, 200 were analyzed (73 wireless; 127 standard); mean age was 61 years, 57% were women, and 51% self-identified as Hispanic, with no significant baseline differences between arms. In the wireless arm, 86% (63/73) transmitted multiple readings, with a median of 159 readings (mean 160.6, SD 129.1) over 6 months, corresponding to 76.2% of expected readings; only 5% of standard-arm participants returned their paper logs. Of 60 survey respondents (82.2% response rate), 95% agreed or strongly agreed the device was easy to set up and use. Both arms showed significant within-arm BP reductions at 6 months (P<.001). At 6 months, 63% of the wireless arm and 74% of the standard arm achieved systolic BP <140 mmHg (P=.079; adjusted odds ratio 1.6, 95% CI 0.78-3.4; P=.19). These exploratory comparisons were not powered and do not constitute evidence of equivalence.

Conclusions:

Wireless HBPM was feasible and highly acceptable in a medically underserved, predominantly Hispanic FQHC population, with high rates of data transmission and user satisfaction, supporting its technical and behavioral viability in FQHC settings. Because this pilot was not powered to compare clinical effectiveness, the absence of a between-arm difference in BP control should not be read as evidence of equivalence; the BP findings are exploratory and hypothesis-generating.