通过基于可穿戴血压监测的新型远程决策支持策略改善初级保健中的血压控制：NEXTGEN-BP随机试验方案。

Transforming blood pressure control in primary care through a novel remote decision support strategy based on wearable blood pressure monitoring: The NEXTGEN-BP randomized trial protocol.

作者信息

Gnanenthiran Sonali R, Tan Isabella, Atkins Emily R, Avolio Alberto, Bennett Belinda, Chapman Niamh, Chow Clara K, Freed Ruth, Gnjidic Danijela, Hespe Charlotte, Kaur Baldeep, Liu Huei Ming, Patel Anushka, Peiris David, Reid Christopher M, Schlaich Markus, Sharman James E, Stergiou George S, Usherwood Tim, Gianacas Christopher, Rodgers Anthony, Schutte Aletta E

机构信息

Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Cardiology Department, Concord Repatriation General Hospital, Sydney, NSW, Australia.

Cardiovascular Division, The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Macquarie Medical School, Macquarie University, Sydney, NSW, Australia.

出版信息

Am Heart J. 2023 Nov;265:50-58. doi: 10.1016/j.ahj.2023.07.005. Epub 2023 Jul 20.

DOI:10.1016/j.ahj.2023.07.005

PMID:37479162

Abstract

BACKGROUND

Despite high blood pressure being the leading preventable risk factor for death, only 1 in 3 patients achieve target blood pressure control. Key contributors to this problem are clinical inertia and uncertainties in relying on clinic blood pressure measurements to make treatment decisions.

METHODS

The NEXTGEN-BP open-label, multicenter, randomized controlled trial will investigate the efficacy, safety, acceptability and cost-effectiveness of a wearable blood pressure monitor-based care strategy for the treatment of hypertension, compared to usual care, in lowering clinic blood pressure over 12 months. NEXTGEN-BP will enroll 600 adults with high blood pressure, treated with 0 to 2 antihypertensive medications. Participants attending primary care practices in Australia will be randomized 1:1 to the intervention of a wearable-based remote care strategy or to usual care. Participants in the intervention arm will undergo continuous blood pressure monitoring using a wrist-wearable cuffless device (Aktiia, Switzerland) and participate in 2 telehealth consultations with their primary care practitioner (general practitioner [GP]) at months 1 and 2. Antihypertensive medication will be up-titrated by the primary care practitioner at the time of telehealth consults should the percentage of daytime blood pressure at target over the past week be <90%, if clinically tolerated. Participants in the usual care arm will have primary care consultations according to usual practice. The primary outcome is the difference between intervention and control in change in clinic systolic blood pressure from baseline to 12 months. Secondary outcomes will be assessed at month 3 and month 12, and include acceptability to patients and practitioners, cost-effectiveness, safety, medication adherence and patient engagement.

CONCLUSIONS

NEXTGEN-BP will provide evidence for the effectiveness and safety of a new paradigm of wearable cuffless monitoring in the management of high blood pressure in primary care.

TRIAL REGISTRATION

ACTRN12622001583730.

摘要

背景

尽管高血压是导致死亡的主要可预防风险因素，但只有三分之一的患者实现了血压控制目标。造成这一问题的关键因素是临床惰性以及依靠诊室血压测量来做出治疗决策时存在的不确定性。

方法

NEXTGEN-BP开放标签、多中心、随机对照试验将研究一种基于可穿戴血压监测仪的护理策略与常规护理相比，在12个月内降低诊室血压方面治疗高血压的疗效、安全性、可接受性和成本效益。NEXTGEN-BP将招募600名服用0至2种抗高血压药物的成年高血压患者。在澳大利亚初级保健机构就诊的参与者将按1:1随机分配至基于可穿戴设备的远程护理策略干预组或常规护理组。干预组的参与者将使用腕戴式无袖带设备（瑞士Aktiia公司）进行连续血压监测，并在第1个月和第2个月与他们的初级保健医生（全科医生[GP]）进行2次远程医疗咨询。如果过去一周白天血压达标的百分比<90%且临床耐受，初级保健医生将在远程医疗咨询时上调抗高血压药物剂量。常规护理组的参与者将按照常规做法进行初级保健咨询。主要结局是干预组和对照组从基线到12个月诊室收缩压变化的差值。次要结局将在第3个月和第12个月进行评估，包括患者和医生的可接受性、成本效益、安全性、药物依从性和患者参与度。