Phone-Based Intervention Under Nurse Guidance for Control of Hypertension After Stroke: A Randomized Multicenter Phase 3 Trial in Ghana.

Under routine care settings, <10% of adults living with hypertension ever achieve blood pressure control, accentuating risks for adverse vascular events.

在常规护理环境中，<10%的高血压成人患者能够实现血压控制，这加剧了不良血管事件的风险。

The effectiveness of mobile health-centered, nurse-led interventions for the control of hypertension among patients with recent stroke in a resource-limited African setting is unknown.

在资源有限的非洲环境中，以移动健康为中心、由护士主导的干预措施对于控制近期中风患者的高血压效果尚不明确。

Methods

The PINGS (Phone-Based Intervention Under Nurse Guidance After Stroke II) trial compared the efficacy and safety of usual care versus a 12-month intervention comprising home blood pressure self-monitoring with nurse case management for elevated home blood pressure recordings, use of phone alarms as medication reminders, and once-weekly education about cardiovascular risk reduction delivered by regular telephonic audio messages in selected Ghanaian dialects.

PINGS（护士指导下的电话干预 II）试验比较了常规护理与一项为期12个月的干预措施的有效性和安全性，后者包括家庭血压自我监测与护士病例管理，用于管理升高的家庭血压记录，使用电话警报作为服药提醒，以及通过定期的电话音频消息以选定的加纳方言每周进行一次关于心血管风险降低的教育。

This was a multicenter, randomized, open-label, blinded end point evaluation trial conducted at 10 hospitals between October 23, 2020, and April 5, 2024.

这是一项多中心、随机、开放标签、盲法终点评估试验，于2020年10月23日至2024年4月5日在10家医院进行。

We enrolled 500 patients ≥18 years with stroke within 1 month of onset and elevated blood pressure ≥140 or ≥90 mm Hg.

我们招募了500名年龄≥18岁、在发病1个月内出现中风且血压升高≥140或≥90毫米汞柱的患者。

The primary outcome was systolic blood pressure <140 mm Hg at month 12 by intention-to-treatprinciple.

主要结果是根据意向治疗原则，12个月时收缩压<140毫米汞柱。

Secondary outcomes included major adverse cardiovascular events and serious adverse events.

次要结果包括主要不良心血管事件和严重不良事件。

Results

A total of 244 participants were assigned to the intervention group (PINGS) and 256 to the usual care group, of whom 43% were women, with mean (SD) age 58 (11) years.

共有244名参与者被分配到干预组（PINGS），256名被分配到常规护理组，其中43%为女性，平均（标准差）年龄为58（11）岁。

Mean change in systolic blood pressure at month 12 from baseline was -5.5 mm Hg (95% CI, -9.6 to -1.4 mm Hg; P=0.008).

从基线到第12个月，收缩压的平均变化为-5.5毫米汞柱（95%置信区间，-9.6至-1.4毫米汞柱；P=0.008）。

The primary outcome was achieved in 163 (67%) patients with PINGS versus 109 (43%) in the usual care arm, with a between-group difference of 24% (95% CI, 15%-33%; P<0.001).

主要结果在163名（67%）使用PINGS的患者中实现，而在常规护理组中为109名（43%），两组之间的差异为24%（95% 置信区间，15%-33%；P<0.001）。

No significant between-group differences were noted in the secondary outcome of major adverse cardiovascular events or the presumed key mediator of medication adherence.

在次要结果的主要不良心血管事件或假定的关键药物依从性介质方面，未注意到两组之间有显著差异。

Serious adverse events were 27 of 244 (11.1%) with PINGS versus 18 of 256 (7.0%) in usual care (P=0.12).

严重不良事件在244名PINGS患者中为27例（11.1%），而在256名常规护理患者中为18例（7.0%）（P=0.12）。

Conclusions

Leveraging mobile health intervention with minimal sophistication and task shifting to nurses on top of usual care safely improved blood pressure control among stroke survivors in a low-resource setting.

在低资源环境中，利用移动健康干预措施，对护士进行最小程度的技能转移，并在常规护理的基础上，安全地改善了中风幸存者的血压控制。

Further study is warranted to confirm these findings and understand outcome drivers.

需要进一步的研究来确认这些发现并理解结果驱动因素。

registration

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04404166.

网址: https://www.clinicaltrials.gov; 唯一标识符: NCT04404166。