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

改善 ACS 后患者的药物依从性：1B 期剂量探索随机对照试验

• 批准号: 7468352
• 负责人: Karina W. Davidson
• 金额: $ 14.06万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7468352
• 关键词: Adherence; Adrenergic beta-Antagonists; Antidepressive Agents; Applications Grants; Aspirin; Behavior Therapy; Behavioral; Behavioral Medicine; Cardiology; Caring; Clinical; Clinical Trials Design; Complex; Condition; Data; Development; Dose; Electronics; Enrollment; Event; Frequencies; Future; Goals; Hospitalization; Hospitals; Hour; Intervention; Life; Maximum Tolerated Dose; Measures; Medical; Mentors; Myocardial Infarction; Numbers; Nurses; Patients; Pharmaceutical Preparations; Phase; Population Intervention; Problem Solving; Problem behavior; Psychological Theory; Quality of Care; Randomized; Randomized Controlled Trials; Range; Rate; Research; Research Personnel; Review, Systematic (PT); Science; Series; Structure; Supervision; Survival Rate; Telephone; Testing; Time; Training; Treatment Protocols; Work; acute coronary syndrome; base; behavioral cardiology; career; cohort; compliance behavior; day; design; experience; improved; innovation; medication compliance; mortality; pill; problem solving therapy; theories

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.

描述（由申请人提供）： 研究目的：确定电话传递的问题解决疗法（PST）的最佳剂量，以提高非依从性急性冠脉综合征（ACS）后患者的药物依从性（使用电子药丸容器测量）。 职业发展目标：（1）增加我在I期行为医学试验设计和执行方面的专业知识。(2)增加我在进行和监督行为医学干预的系统评价方面的专业知识。这种专业知识将使我能够指导开始临床研究人员进行有效测试行为干预所需的全方位临床试验设计。 指导计划：我提出了一系列的教学课程，量身定制的指导，和结构化的研究经验，以提高我的学员的研究生涯的独立性。我将与来自各种专业背景的学员一起工作，从而丰富整个团队以及我自己和我的同事的科学和指导。 研究计划：多达20%的ACS后患者不遵守他们的处方药物，即使在ACS事件发生后的30天内也是如此。与依从性患者相比，这些患者的死亡率增加。然而，有效的，廉价的，可推广的依从性干预措施仍然不可用。我将应用一个创新的行为理论-行为激活-的问题，不遵守，使用随机的，受控的，剂量（频率）-递增的电话干预，以确定最低有效剂量（MED）和最大耐受剂量（MTD）的MEMS评估阿司匹林的遵守。12名ACS后患者的队列将被随机分配到心脏病护理组或PST治疗组，持续30天。每个队列的PST频率将从2次增加到10次。MED将定义为两种情况之间检测到20%依从性差异的剂量，MTD将定义为33%（2/6）患者错过一次PST治疗的剂量。这项研究将允许我和我的学员进行早期行为试验，与非依从性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。