在联邦合格健康中心采用无线家庭血压监测结合健康指导进行高血压管理：随机对照试点可行性及可接受性研究。
完整摘要 · 中文译文
背景：高血压是主要心血管危险因素，但仅约半数高血压成人实现血压（BP）控制，且低收入和少数族裔人群中持续存在差异。无线家庭血压监测（HBPM）联合远程患者监测可改善血压控制，但在由联邦合格健康中心（FQHCs）服务的医疗服务不足、以西班牙裔为主的人群中证据有限。 目的：主要目的是评估在接受FQHC医疗照护、以西班牙裔为主的高血压成人中开展无线HBPM的可行性和可接受性。比较无线HBPM与传统HBPM之间的血压结局是一项次要探索性目的。 方法：我们在圣迭戈：心脏病发作和卒中零发生区项目内嵌套开展了一项为期6个月、2组的随机对照试点可行性及可接受性试验。年龄≥18岁、患有未控制或新诊断高血压（血压≥140/90 mm Hg）的成人从3个FQHC网络入组，并通过非限制性简单随机化按1:1随机分配至无线HBPM（蓝牙袖带和蜂窝集线器；健康教练审阅每周传输的摘要）或标准HBPM（家用监测仪加纸质日志）。两组均接受标准化健康指导。主要结局为可行性（210次预期血压读数中已传输的比例）和可接受性（无线组干预后满意度调查）。探索性分析比较了血压测量次数>2的参与者中两组间的血压结局。 结果：在316名招募的参与者中，290名（92%）为 符合条件者，共200名（63%）纳入分析（无线组：n=73，占23%；标准组：n=127，占40%）；未保留各臂分配计数。平均年龄为61岁（SD 9.1），57%（115/200）为女性，51%（n=102）自我认定为西班牙裔，各组间基线无显著差异。在纳入分析的无线组参与者中，86%（63/73）在6个月内传输了多次读数（平均值160.6，SD 129.1），相当于传输参与者预期读数的76.2%（160/210），在全部73名参与者中占66%；仅5%（7/127）的标准组参与者交回了纸质日志。在60名受访者中（应答率为82.2%），95%（n=57）同意或强烈同意该设备易于设置和使用。两组在6个月时的组内血压均显著降低（P<.001）。在6个月时，无线组中63%（46/73）和标准组中74%（94/127）实现了收缩压<140 mm Hg（P=.08；校正比值比，标准组 vs 无线组，1.6，95% CI 0.78-3.4；P=.19）。这些探索性比较未达到检验效能，不构成等效性证据。 结论：在纳入分析的参与者中，无线家庭血压监测（HBPM）是可行的，调查受访者在医疗服务不足、以西班牙裔为主的联邦合格健康中心（FQHC）人群中报告了较高的可接受性。由于未保留各臂分配计数，无法估计所有随机参与者中的可行性。血压控制方面未观察到组间差异并不构成等效性证据，因为本试点研究未设计用于比较临床有效性；血压发现仅用于产生假说。
完整摘要 · 英文原文
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.