Gerin William, Tobin Jonathan N, Schwartz Joseph E, Chaplin William, Rieckmann Nina, Davidson Karina W, Goyal Tanya M, Jhalani Juhee, Cassells Andrea, Feliz Karina, Khalida Chamanara, Diaz-Gloster Marleny, Ogedegbe Gbenga
Columbia University, College of Physicians and Surgeons, New York-Presbyterian Hospital, New York, NY, USA.
Contemp Clin Trials. 2007 Jul;28(4):459-71. doi: 10.1016/j.cct.2007.01.003. Epub 2007 Jan 12.
The Medication Adherence and BP Control Trial (ABC Trial) is a randomized, controlled, multi-site, medication adherence and blood pressure (BP) control trial in an economically disadvantaged and multi-cultural population of hypertensive patients followed in primary care practices. To date, no other such trial has been published in which objective measures of adherence (electronic pill bottles) were used to assess the effectiveness of these behavioral interventions for hypertension. This study tested a combination of commercially-available interventions that can be easily accessed by health care providers and patients, and therefore may provide a real-world solution to the problem of non-adherence among hypertensives. The aim of the ABC Trial was to test the effectiveness of a stepped care intervention in improving both medication adherence to an antihypertensive medication regimen and BP control. Step 1 of the intervention employed home Self-BP Monitoring (SBPM); at this stage, there were two arms: (1) Usual Care (UC) and (2) Intervention. At Step 2, patients in the intervention arm whose BP had not come under control after 3 months were further randomized to one of two conditions: (1) continuation of SBPM (alone) or (2) continuation of SBPM plus telephone-based nurse case management (SBPM+NCM). Electronic Medication Event Monitoring (MEMS) was the primary measure of medication adherence, and in-office BP was the primary measure of hypertension control. We present an overview of the study design, details of the administrative structure of the study and a description of clinical site recruitment, patient recruitment, and follow-up assessments.
药物依从性与血压控制试验（ABC试验）是一项随机对照多中心试验，针对基层医疗实践中经济条件较差且具有多元文化背景的高血压患者群体，研究药物依从性与血压（BP）控制情况。迄今为止，尚未有其他此类试验发表，即利用客观的依从性测量方法（电子药瓶）来评估这些行为干预措施对高血压的有效性。本研究测试了一系列医疗服务提供者和患者均可轻松获取的市售干预措施组合，因此可能为高血压患者的不依从问题提供切实可行的解决方案。ABC试验的目的是测试逐步护理干预措施在提高抗高血压药物治疗方案的药物依从性和血压控制方面的有效性。干预的第一步采用家庭自测血压（SBPM）；在此阶段，有两个分组：（1）常规护理（UC）和（2）干预组。在第二步，干预组中3个月后血压未得到控制的患者被进一步随机分为两种情况之一：（1）继续单独进行SBPM或（2）继续进行SBPM并加上基于电话的护士病例管理（SBPM+NCM）。电子药物事件监测（MEMS）是药物依从性的主要测量指标，诊室血压是高血压控制的主要测量指标。我们概述了研究设计、研究管理结构的细节以及临床站点招募、患者招募和随访评估的描述。
