Lay community health worker-led care with mobile decision support for uncontrolled hypertension: a cluster-randomized trial.

Community health workers (CHWs), lay providers living in the communities they serve, may help close this gap, but the effectiveness and safety of lay CHW-led hypertension care-including independent initiation and titration of medication-remain uncertain.

社区卫生工作者（CHWs），即居住在其服务社区的非专业提供者，可能有助于缩小这一差距，但由非专业CHW领导的高血压护理的有效性和安全性——包括独立启动和调整药物剂量——仍然不确定。

We conducted a 1:1 cluster-randomized trial nested within the Community-Based Chronic Care Lesotho (ComBaCaL) cohort study in 103 rural villages in Lesotho.

我们在莱索托的103个农村村庄中进行了一项1:1的群组随机试验，该试验嵌套在基于社区的慢性病照护莱索托（ComBaCaL）队列研究中。

Following community-based hypertension screening, 547 nonpregnant adults with blood pressure (BP) ≥140/90 mm Hg were enrolled (274 control and 273 intervention).

在社区为基础的高血压筛查后，共有547名非怀孕成年人血压（BP）≥140/90毫米汞柱被纳入研究（对照组274人，干预组273人）。

In intervention clusters, lay CHWs independently prescribed and titrated a fixed-dose combination of amlodipine and hydrochlorothiazide, guided by a mobile clinical decision support system.

在干预组中，非专业社区卫生工作者（CHWs）独立地根据移动临床决策支持系统指导，开具并调整氨氯地平和氢氯噻嗪的固定剂量组合。

In control clusters, participants were referred to health facilities for standard care.

在对照组中，参与者被推荐到医疗机构接受标准治疗。

The primary objective was to assess the effectiveness and safety of lay CHW-led care, with the primary outcome defined as BP <140/90 mm Hg at 12 months.

主要目标是评估由非专业社区卫生工作者领导的护理的有效性和安全性，主要结果定义为在12个月时血压<140/90毫米汞柱。

In the intention-to-treatanalysis (543 participants with 4 exclusions owing to intercurrent pregnancy), BP control was achieved by 156/271 (58%) versus 130/272 (48%) in intervention and control arms, respectively (adjusted odds ratio 1.52, 95% confidence interval1.01 to 2.29, P = 0.046).

在意向治疗分析中（543名参与者中有4名因间歇性怀孕而被排除在外），干预组和对照组分别有156/271（58%）和130/272（48%）的参与者达到了血压控制（调整后的比值比为1.52，95%置信区间为1.01至2.29，P=0.046）。

A predefined complete case analysis yielded consistent results.

预先定义的完整案例分析得出了结果一致。

No relevant differences in safety outcomes were observed.

在安全性结果中未观察到相关差异。

Among people with uncontrolled hypertension, lay CHW-led, CDSS-supported care was safe and more effective than referral to facility-based professional care.

在未控制高血压的人群中，由非专业社区卫生工作者领导的、临床决策支持系统支持的护理是安全的，并且比转诊到设施基础的专业护理更有效。

These findings support expanding first-line hypertension management by lay CHWs in remote, resource-limited settings.

这些发现支持在偏远和资源有限的环境中，扩大由非专业社区卫生工作者进行的一线高血压管理。

Clinicaltrials.gov registration: NCT05684055 .

临床试验注册：NCT05684055。