Juliette Vay-Demouy, Hélène Lelong, Jacques Blacher
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引用次数: 0
Abstract
The aim of this pilot study was to test the feasibility of a clinical trial to evaluate the impact of an advanced practice nurse (APN) intervention on blood pressure (BP) control versus usual care in hypertension management, and to provide initial trends. This pilot study was designed as a prospective, open-label, randomized 1:1, controlled, and monocentric superiority trial, conducted in a French-labeled European Society of Hypertension excellence center. The APN intervention consisted of an in-depth therapeutic education and an assessment of therapeutic strategies with adjustments if needed. The study sample included 437 participants (n = 229 in the experimental group; n = 208 in the “usual care” group). Considering the selection bias identified for baseline systolic BP, statistical analyses were adjusted on this parameter. The APN intervention significantly reduced adjusted systolic BP in the experimental group compared with the “usual care” group (−2.72 mm Hg, p = 0.04) and showed a trend toward a decrease in adjusted diastolic BP (−1.85 mm Hg, p = 0.07) and improved BP control with the APN intervention (−8.5%, p = 0.08). The experimental group was significantly more likely to adhere to the HBPM protocol compared with the control group (OR = 1.82, 95% CI [1.22–2.71], p = 0.003). This pilot study confirmed the feasibility of the clinical trial and offered the first data about APNs in hypertension management in France. Initial significant or borderline significant results are encouraging and suggest the benefit of an APN intervention on BP control in hypertension management. Further studies are needed to confirm these results.
Trial registration: This clinical trial was registered on ClinicalTrials platform (NCT06227884).
本初步研究的目的是测试一项临床试验的可行性，以评估高级执业护士（APN）干预对血压（BP）控制的影响，而不是高血压管理中的常规护理，并提供初步趋势。本初步研究设计为前瞻性、开放标签、1:1随机、对照、单中心优势试验，在法国标签的欧洲高血压学会卓越中心进行。APN干预包括深入的治疗教育和评估治疗策略，如果需要的话进行调整。研究样本包括437名参与者(实验组n = 229；“常规护理”组N = 208)。考虑到基线收缩压的选择偏差，对该参数进行统计分析。与常规护理组相比，APN干预显著降低了实验组的调整后收缩压（- 2.72 mm Hg, p = 0.04），并有降低调整后舒张压（- 1.85 mm Hg, p = 0.07）和改善血压控制的趋势（- 8.5%,p = 0.08）。实验组坚持HBPM方案的可能性明显高于对照组（OR = 1.82, 95% CI [1.22-2.71], p = 0.003）。该试点研究证实了临床试验的可行性，并提供了关于apn在法国高血压治疗中的第一个数据。初步显著或临界显著的结果令人鼓舞，表明APN干预在高血压管理中对血压控制的益处。需要进一步的研究来证实这些结果。试验注册：本临床试验在ClinicalTrials平台注册（NCT06227884）。
期刊介绍：
The Journal of Clinical Hypertension is a peer-reviewed, monthly publication that serves internists, cardiologists, nephrologists, endocrinologists, hypertension specialists, primary care practitioners, pharmacists and all professionals interested in hypertension by providing objective, up-to-date information and practical recommendations on the full range of clinical aspects of hypertension. Commentaries and columns by experts in the field provide further insights into our original research articles as well as on major articles published elsewhere. Major guidelines for the management of hypertension are also an important feature of the Journal. Through its partnership with the World Hypertension League, JCH will include a new focus on hypertension and public health, including major policy issues, that features research and reviews related to disease characteristics and management at the population level.
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