高血压治疗中的自动传输家庭血压与自动化患者反馈：AUTO 2试验 (AUTO 2)
2026年5月11日 更新者：Stephen Persell, MD, MPH、Northwestern University
手动记录或自动传输家庭血压监测（无论是否包含自动化患者反馈）对高血压治疗的影响
本研究旨在评估通过患者门户消息发送的关于家庭血压监测结果的自动生成医疗建议与无自动建议相比的有效性，以及远程获取的血压值自动传输与自我报告值相比对西北医学中心初级保健医生或高级执业医师诊治的未控制高血压患者在1年随访时收缩压的有效性。
同时还将评估效果在18个月内的持续情况。
研究概览
研究类型
介入性
注册 (估计的)
1304
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- Northwestern University Feinberg School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 入组时年龄18-84岁
- 主要从参与研究的临床医生处接受高血压治疗
- 患者识别前最近两次门诊动态血压监测日的血压≥140 mmHg收缩压和/或≥90 mmHg舒张压，或最近一次门诊动态血压≥150 mmHg收缩压和/或≥95 mmHg舒张压
- 目前拥有或愿意注册西北医学的患者门户账户
排除标准：
- 痴呆症
- 养老院居民
- 5期慢性肾脏病或肾脏替代治疗
- 妊娠
- 接受临终关怀
- 未计划在未来一年继续由西北医学临床医生提供高血压治疗
- 计划在未来一年内离开该地区
- 计划在未来一年内更换治疗其高血压的临床医生
- 因医疗或心理原因无法进行家庭血压监测
- 已知平均家庭血压或最近家庭血压值<130/80 mmHg
临床医生参与者纳入：在西北医学门诊初级保健站点（家庭医学、内科、内科/儿科和门诊老年医学科）为成人高血压患者提供治疗的医师、高级执业护士或医师助理。
临床医生参与者排除：
- 不愿意其患者参与研究的初级保健医师和临床医生
- 计划在未来一年内离开西北医学
- 不愿意接收患者的诊室外血压数据
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：强化常规护理
参与者将获得一台血压监测仪，并被鼓励将血压结果输入到其电子健康记录患者门户中。
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参与者将获得家用血压监测仪，并学习如何使用电子健康记录门户将家庭收集的血压数据录入电子健康记录。
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有源比较器：远程监测血压的自动传输
参与者将收到一台血压监测仪和一个应用程序，用于直接将测量数据传送到他们的电子健康记录中。
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参与者将获得血压监测仪和应用程序，以自动将家庭血压数据传输至其电子健康记录中。
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有源比较器：自动化患者关于自我血压监测的反馈
参与者会收到一个血压监测仪，并鼓励他们将血压结果输入到电子健康记录（EHR）患者门户中。
参与者会通过EHR患者门户收到有关其家庭血压结果的消息。
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参与者将获得家用血压监测仪，并学习如何使用电子健康记录门户将家庭收集的血压数据录入电子健康记录。
患者将定期收到关于其家庭血压监测结果的信息，并附有在适当时建议咨询临床护理团队的提示。
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有源比较器：远程监测血压的自动传输与自动反馈
参与者将收到一台血压监测仪和一个应用程序，可直接将测量结果传输至其电子健康记录（EHR）。
参与者将通过EHR患者门户收到有关其家庭血压结果的消息。
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参与者将获得血压监测仪和应用程序，以自动将家庭血压数据传输至其电子健康记录中。
患者将定期收到关于其家庭血压监测结果的信息，并附有在适当时建议咨询临床护理团队的提示。
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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12个月时的收缩压
大体时间：12个月
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12个月
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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18个月时的收缩压
大体时间：18个月
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18个月
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相对于基线的降压药物变化
大体时间：从基线到12个月和18个月
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从基线到12个月和18个月
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处方抗高血压药物类别，标准化计数
大体时间：12个月和18个月
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12个月和18个月
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药物依从性（患者报告，主观不依从程度领域）
大体时间：12个月和18个月
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12个月和18个月
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舒张压
大体时间：12个月和18个月
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12个月和18个月
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血压 <130/80 毫米汞柱
大体时间：12个月和18个月
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12个月和18个月
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血压 <140/90 毫米汞柱
大体时间：12个月和18个月
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12个月和18个月
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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患者参与度（消费者健康激活指数）
大体时间：12个月和18个月
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12个月和18个月
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生活质量（PROMIS® 量表 v1.2 - 总体健康）
大体时间：12个月和18个月
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12个月和18个月
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办公室就诊次数
大体时间：从基线至12个月和18个月
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从基线至12个月和18个月
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门户消息数量
大体时间：从基线至12个月和18个月
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从基线至12个月和18个月
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1年和18个月时的电话接触次数
大体时间：从基线到12个月和18个月
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从基线到12个月和18个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Stephen D Persell, MD,MPH、Northwestern University
出版物和有用的链接
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月4日
初级完成 (估计的)
2028年4月1日
研究完成 (估计的)
2028年11月1日
研究注册日期
首次提交
2026年2月2日
首先提交符合 QC 标准的
2026年2月2日
首次发布 (实际的)
2026年2月9日
研究记录更新
最后更新发布 (实际的)
2026年5月12日
上次提交的符合 QC 标准的更新
2026年5月11日
最后验证
2026年5月1日
更多信息
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