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远程血压监测联合社会支持用于高血压患者:一项随机临床试验。

Remote Blood Pressure Monitoring With Social Support for Patients With Hypertension: A Randomized Clinical Trial.

机构信息

Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Center for Health Care Innovation, University of Pennsylvania, Philadelphia.

出版信息

JAMA Netw Open. 2024 Jun 3;7(6):e2413515. doi: 10.1001/jamanetworkopen.2024.13515.

DOI:10.1001/jamanetworkopen.2024.13515
PMID:38829618
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11148689/
Abstract

IMPORTANCE

Hypertension management has traditionally been based on office visits. Integrating remote monitoring into routine clinical practices and leveraging social support might improve blood pressure (BP) control.

OBJECTIVE

To evaluate the effectiveness of a bidirectional text monitoring program focused on BP control and medication adherence with and without social support in adults with hypertension.

DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial included adults aged 18 to 75 treated at an academic family medicine practice in Philadelphia in 2018 and 2019. Patients had been seen at least twice in the prior 24 months and had at least 2 elevated BP measurements (>150/90 mm Hg or >140/90 mm Hg for patients aged 18-59 years or with diabetes or chronic kidney disease) during visits. All participants had a cell phone with text messaging, offered at least 1 support partner, and were taking maintenance medications to treat hypertension. Patients were randomized 2:2:1 to remote monitoring of BP and medication adherence (RM), remote monitoring of BP and medication adherence with feedback provided to a social support partner (SS), or usual care (UC). Data were analyzed on an intention-to-treat basis between October 14, 2019, and May 30, 2020, and were revisited from May 23 through June 2, 2023.

INTERVENTIONS

The RM and SS groups received an automatic home BP monitor, 3 weekly texts requesting BP measurements, 1 weekly text inquiring about medication adherence, and a weekly text with feedback. In the SS arm, support partners received a weekly progress report. The UC group received UC through their primary care practice. Clinicians caring for the patients in the intervention groups received nudges via electronic health records to adjust medications when 3 of 10 reported BP measurements were elevated. Patients were followed up for 4 months.

MAIN OUTCOMES AND MEASURES

The primary outcome was systolic BP at 4 months measured during the final follow-up visit. Secondary outcomes included achievement of normotension and diastolic BP.

RESULTS

In all, 246 patients (mean [SD] age, 50.9 [11.4] years; 175 females [71.1%]; 223 Black individuals [90.7%] and 13 White individuals [5.3%]) were included in the intention-to-treat analysis: 100 patients in the RM arm, 97 in the SS arm, and 49 in the UC arm. Compared with the UC arm, there was no significant difference in systolic or diastolic BP at the 4-month follow-up visit in the RM arm (systolic BP adjusted mean difference, -5.25 [95% CI, -10.65 to 0.15] mm Hg; diastolic BP adjusted mean difference, -1.94 [95% CI, -5.14 to 1.27] mm Hg) or the SS arm (systolic BP adjusted mean difference, -0.91 [95% CI, -6.37 to 4.55] mm Hg; diastolic BP adjusted mean difference, -0.63 [95% CI, -3.77 to 2.51] mm Hg). Of the 206 patients with a final BP measurement at 4 months, BP was controlled in 49% (41 of 84) of patients in the RM arm, 31% (27 of 87) of patients in the SS arm, and 40% (14 of 35) of patients in the UC arm; these rates did not differ significantly between the intervention arms and the UC group.

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial, neither remote BP monitoring nor remote BP monitoring with social support improved BP control compared with UC in adults with hypertension. Additional efforts are needed to examine whether interventions directed at helping patients remember to take their BP medications can lead to improved BP control.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT03416283.

摘要

重要性

高血压管理传统上基于门诊就诊。将远程监测纳入常规临床实践并利用社会支持可能会改善血压(BP)控制。

目的

评估针对 BP 控制和药物依从性的双向文本监测计划的有效性,该计划在有或没有社会支持的情况下,在高血压成年人中进行。

设计、地点和参与者:这项随机临床试验包括 2018 年至 2019 年在费城一家学术家庭医学诊所就诊的 18 至 75 岁成年人。这些患者在过去 24 个月内至少就诊过 2 次,并且在就诊期间至少有 2 次血压升高(>150/90mmHg 或 >140/90mmHg 适用于 18-59 岁的患者或患有糖尿病或慢性肾病的患者)。所有参与者都有一部可以发送短信的手机,至少有 1 个支持伙伴,并正在服用维持高血压治疗的药物。患者被随机分为远程监测血压和药物依从性(RM)组、远程监测血压和药物依从性并向社会支持伙伴提供反馈(SS)组或常规护理(UC)组。数据分析基于意向治疗原则,于 2019 年 10 月 14 日至 2020 年 5 月 30 日进行,并于 2023 年 5 月 23 日至 6 月 2 日重新进行。

干预措施

RM 和 SS 组患者接受自动家庭血压监测仪、每周 3 次要求测量血压的短信、每周 1 次询问药物依从性的短信以及每周 1 次带有反馈的短信。在 SS 臂中,支持伙伴会收到每周进展报告。UC 组通过他们的初级保健实践接受 UC。治疗干预组患者的临床医生会通过电子健康记录收到提示,当 10 次报告中有 3 次血压升高时,调整药物。患者随访 4 个月。

主要结果和测量指标

主要结局是在最后一次随访期间测量的 4 个月时的收缩压。次要结局包括达到正常血压和舒张压。

结果

共有 246 名患者(平均[标准差]年龄,50.9[11.4]岁;175 名女性[71.1%];223 名黑人个体[90.7%]和 13 名白人个体[5.3%])被纳入意向治疗分析:RM 臂 100 名患者,SS 臂 97 名患者,UC 臂 49 名患者。与 UC 臂相比,RM 臂(收缩压调整平均差异,-5.25[95%CI,-10.65 至 0.15]mmHg;舒张压调整平均差异,-1.94[95%CI,-5.14 至 1.27]mmHg)或 SS 臂(收缩压调整平均差异,-0.91[95%CI,-6.37 至 4.55]mmHg;舒张压调整平均差异,-0.63[95%CI,-3.77 至 2.51]mmHg)在 4 个月随访时收缩压或舒张压均无显著差异。在 206 名最终在 4 个月时进行血压测量的患者中,RM 臂 49%(84 名患者中的 41 名)、SS 臂 31%(87 名患者中的 27 名)和 UC 臂 40%(35 名患者中的 14 名)的患者血压得到控制;这些比率在干预组与 UC 组之间没有显著差异。

结论和相关性

在这项随机临床试验中,与 UC 相比,高血压成年人中远程血压监测或远程血压监测联合社会支持均未改善血压控制。需要进一步努力研究旨在帮助患者记住服用降压药物的干预措施是否可以改善血压控制。

试验注册

ClinicalTrials.gov 标识符:NCT03416283。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2790/11148689/399765cc462f/jamanetwopen-e2413515-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2790/11148689/399765cc462f/jamanetwopen-e2413515-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2790/11148689/399765cc462f/jamanetwopen-e2413515-g001.jpg

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