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Efficacy of a brief multifactorial adherence-based intervention in reducing blood pressure: a randomized clinical trial

机译:简短的基于多因素依从性干预措施降低血压的功效:一项随机临床试验

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Background: Lowering blood pressure (BP) by antihypertensive (AHT) drugs reduces the risks of cardiovascular events, stroke, and total mortality. However, poor adherence to AHT medications reduces their effectiveness and increases the risk of adverse events.Objective: To evaluate the effectiveness of a multifactorial adherence-based intervention in a primary care setting in lowering BP.Methods/design: Multicenter parallel randomized controlled trial. Thirty two nurses in 28 primary care centers of three Spanish regions. Patients aged 18–80 years, taking AHT drugs with uncontrolled BP (n=221) were randomized to a control group (usual care) or a multifactorial adherence-based intervention including nurse-led motivational interviews, pill reminders, family support, BP self-recording, and simplification of the dosing regimen by a pharmacist.Main outcome measures: The primary outcome was 12-month blinded measure of systolic BP (mean of three measurements). The secondary outcomes were 12-month diastolic BP and proportion of patients with adequately controlled BP.Results: One hundred and fourteen patients were allocated to the intervention group and 109 to the control group. At 12 months, 212 (89%) participants completed the study. The systolic BP in the intervention group was 151.3 versus 153.7 in the control group (P=0.294). The diastolic BP did not differ between groups (83.4 versus 83.6). Of the patients in the control group, 9.2% achieved BP control versus a 15.8% in the intervention group. The relative risk for achieving BP control was 1.72 (95% confidence interval: 0.83–3.56).Conclusion: A multifactorial intervention based on improving adherence in patients with uncontrolled hypertension failed to find evidence of effectiveness in lowering systolic BP.Trial registration: ISRCTN21229328.
机译:背景:通过降压(AHT)药物降低血压(BP)可以降低心血管事件,中风和总死亡率的风险。然而,对AHT药物依从性差会降低其有效性并增加发生不良事件的风险。目的:评估基于多因素依从性的干预措施在基层医疗机构中降低BP的有效性。方法/设计:多中心平行随机对照试验。西班牙三个地区的28个初级保健中心的32名护士。年龄在18-80岁之间,服用不受控制的BP的AHT药物(n = 221)的患者被随机分为对照组(常规护理)或基于多因素依从性的干预措施,包括由护士主导的动机访谈,催眠药,家庭支持,血压自我-记录和简化药剂师的给药方案。主要结果指标:主要结果是对收缩压进行12个月的盲法测量(三个测量值的平均值)。次要结果为舒张压12个月和血压得到适当控制的患者比例。结果:干预组分配了114例患者,对照组分配了109例。在12个月时,有212位(89%)参与者完成了研究。干预组的收缩压为151.3,而对照组为153.7(P = 0.294)。两组之间的舒张压无差异(分别为83.4和83.6)。在对照组中,有9.2%的患者实现了BP控制,而干预组中只有15.8%。控制血压的相对风险为1.72(95%置信区间:0.83–3.56)。结论:在无法控制的高血压患者中,基于改善依从性的多因素干预措施未能发现降低收缩压的有效证据。试验注册:ISRCTN21229328。

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