Wireless Home Blood Pressure Monitoring With Health Coaching for Hypertension Management at a Federally Qualified Health Center: Pilot Randomized Controlled Feasibility and Acceptability Study

Background Only approximately half of adults with hypertension, a leading cardiovascular risk factor, achieve blood pressure (BP) control, with persistent disparities among low-income and minority populations. Wireless home BP monitoring (HBPM) with remote patient monitoring can improve BP control, 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 FQHC care. Comparing BP outcomes between wireless and conventional HBPM was a secondary exploratory objective. Methods We conducted a 6-month, 2-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 mm Hg) were enrolled across 3 FQHC networks and randomized 1:1 by unrestricted simple randomization to wireless HBPM (Bluetooth cuff and cellular hub; weekly transmitted summaries reviewed by health coaches) or standard HBPM (home monitor with paper log). Both arms received standardized health coaching. The primary outcomes were feasibility (proportion of 210 expected BP readings transmitted) and acceptability (postintervention satisfaction survey in the wireless arm). Exploratory analyses compared BP outcomes between arms among participants with >2 BP measurements. Results Of 316 recruited participants, 290 (92%) were eligible, and 200 (63%) were analyzed (wireless: n=73, 23%; and standard: n=127, 40%); arm-level allocation counts were not retained. The mean age was 61 years (SD 9.1), 57% (115/200) were women, and 51% (n=102) self-identified as Hispanic, with no significant baseline differences between arms. Among analyzed wireless-arm participants, 86% (63/73) transmitted multiple readings (mean 160.6, SD 129.1) over 6 months, corresponding to 76.2% (160/210) of expected readings among transmitting participants and 66% across all 73; only 5% (7/127) of standard-arm participants returned paper logs. Of 60 respondents (82.2% response rate), 95% (n=57) agreed or strongly agreed that 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% (46/73) of the wireless arm and 74% (94/127) of the standard arm achieved systolic BP <140 mm Hg ( P =.08; adjusted odds ratio, standard vs wireless, 1.6, 95% CI 0.78‐3.4; P =.19). These exploratory comparisons were not powered and do not constitute evidence of equivalence. Conclusions Among analyzed participants, wireless HBPM was feasible, and survey respondents reported high acceptability in a medically underserved, predominantly Hispanic FQHC population. Feasibility among all randomized participants could not be estimated because arm-level allocation counts were not retained. The absence of a between-arm difference in BP control is not evidence of equivalence because this pilot was not powered to compare clinical effectiveness; the BP findings are hypothesis generating.