Improving Med Adherence in Post-ACS Patients: Phase 1B Dose-Finding RCT

描述(由申请人提供)： 研究目标：确定电话传递的问题解决疗法(PST)的最佳剂量，以改善非粘附性急性冠脉综合征(ACS)患者的用药依从性(使用电子药丸容器测量)。 职业发展目标：(1)增加我在第一阶段行为医学试验设计和执行方面的专业知识。(2)增加我在指导和监督行为医学干预措施系统评价方面的专业知识。这种专业知识将使我能够在有效测试行为干预所需的全面临床试验设计中指导初级临床研究人员。 指导计划：我提出了一系列教学课程、量身定做的指导和结构化的研究经验，以提高我的受训者研究生涯的独立性。我将与来自不同专业背景的学员合作，从而丰富整个团队的科学知识和指导，也为我和我的同事们提供帮助。 研究计划：多达20%的急性冠脉综合征后患者没有遵守他们的处方药物，即使在急性冠脉综合征事件发生后的30天内也是如此。与依从性患者相比，这些患者的死亡率更高。然而，有效的、廉价的、可推广的依从性干预措施仍然不可用。我将应用一种创新的行为理论-行为激活-来解决不依从性问题，使用随机、可控、剂量(频率)递增的电话干预来确定MEMS评估的阿司匹林依从性的最低有效剂量(MED)和最大耐受量(MTD)。12名急性冠脉综合征后患者将被随机分配到常规心脏科护理或接受为期30天的PST治疗。每个队列的PST频率将从2次增加到10次。MED将被定义为在两种情况下检测到20%的依从性差异的剂量，MTD将被定义为33%(2/6)的患者错过了一次PST疗程的剂量。这项研究将使我和我的受训人员能够进行早期的行为试验，与未坚持治疗的患者和心脏病专家进行广泛的互动，以便更好地了解这一具有挑战性的行为问题。

DESCRIPTION (provided by applicant): Research Goal: To identify the optimal dose of telephone-delivered problem solving therapy (PST) that improves medication adherence (measured using electronic pill containers) in non-adherent post-Acute Coronary Syndrome (ACS) patients. Career Development Goals: (1) to increase my expertise in Phase I behavioral medicine trial design and execution. (2) to increase my expertise in conducting and supervising systematic reviews of behavioral medicine interventions. This expertise will allow me to mentor beginning clinical researchers in the full range of clinical trial designs required to effectively test behavioral interventions. Mentoring Plan: I am proposing a series of didactic courses, tailored mentoring, and structured research experiences to increase the independence of my trainees' research careers. I will work with trainees from a variety of professional backgrounds, thus enriching the science and mentoring for the entire group, as well as for myself and my colleagues. Research Plan: As many as 20% of post ACS patients are not adherent to their prescribed medications, even in the 30 days immediately following an ACS event. These patients have an increased mortality rate compared to adherent patients. However, effective, inexpensive, generalizable adherence interventions remain unavailable. I will apply an innovative behavioral theory-Behavioral Activation-to the problem of non-adherence, using a randomized, controlled, dose (frequency)-escalating telephone intervention to determine the Minimally Effective Dose (MED) and the Maximally Tolerated Dose (MTD) for MEMS assessed aspirin adherence. Cohorts of 12 post-ACS patients will be randomized to Usual Cardiology Care or to PST sessions for 30 days. PST frequency will increase from 2 to10 sessions for each cohort. The MED will defined as the dose at which a 20% adherence difference is detected between the two conditions, and MTD will be defined as the dose at which 33% (2/6) patients have missed one PST session. This research will allow my trainees and me to conduct an early phase behavioral trial, interact extensively with nonadherent patients and cardiologists, so as to better understand this challenging behavioral problem.