Investigating fear of recurrence as a modifiable mechanism of behavior change to improve medication adherence in acute coronary syndrome patients

研究对复发的恐惧作为行为改变的可修改机制，以提高急性冠脉综合征患者的药物依从性

• 批准号: 9607756
• 负责人: Jeffrey Lee Birk
• 金额: $ 24.3万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-31 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9607756
• 关键词: Acute; Address; Adherence; Affective; Aspirin; Attention; Behavior; Behavioral Mechanisms; Benign; Biological Assay; Cancer Patient; Cancer Survivor; Cardiac; Cardiovascular Diseases; Cardiovascular system; Categories; Cognitive; Cues; Data; Disease; Distal; Distress; Double-Blind Method; Emotions; Enrollment; Equipment and supply inventories; Event; Failure; Fatigue; Fright; Future; Goals; Health behavior; Home environment; Hospitals; Hour; Inpatients; Intervention; Life; Link; Measures; Mediation; Medical; Medicine; Morbidity - disease rate; Myocardial Infarction; Participant; Patient Education; Patients; Pattern; Pharmaceutical Preparations; Physicians; Population; Post-Traumatic Stress Disorders; Preventive; Probability; Randomized; Recurrence; Reporting; Risk; Science; Secondary Prevention; Secondary to; Sleep; Stimulus; Survivors; Symptoms; Testing; Thinking; Time; Training; Unstable angina; Work; acute coronary syndrome; acute stress; acute traumatic stress disorder; assault; associated symptom; behavior change; brief intervention; cancer recurrence; cardiovascular disorder risk; combat; computerized; design; discount; discounting; follow-up; high risk; improved; indexing; intervention effect; medication compliance; mortality; psychologic; repository; successful intervention; traumatic event

Acute coronary syndrome (ACS; myocardial infarction or unstable angina) is a leading cause of morbidity and mortality in the U.S., with >1 million cases per year. Survivors are at high risk for recurrent cardiovascular disease (CVD) events, particularly if they do not adhere to risk- reducing medications. Unfortunately, nonadherence among ACS patients is very common (~50%), and no effective, scalable interventions exist. Addressing medication nonadherence in ACS patients requires an experimental medicine approach to identify specific mechanisms of behavior change in populations for whom those mechanisms are most relevant and modifiable. Accumulating evidence suggests that the many patients who develop post-traumatic stress disorder (PTSD) symptoms following ACS view their medications as reminders of their cardiac event and their future CVD risk. Ironically, although it has rarely been studied outside of cancer survivors, this fear of recurrence (FoR) may undermine medication adherence in ACS patients. This project will use the Science of Behavior Change (SOBC) experimental medicine approach to investigate FoR as a putative mechanism of behavior change with respect to aspirin adherence among ACS patients with early PTSD symptoms at hospital discharge. We will test a cognitive- affective intervention that has been shown to reduce FoR in cancer survivors, that is delivered electronically (IPad) in the patient’s home. We have begun adapting this intervention for ACS, and will test it using a double-blind randomized controlled design. We will enroll n=100 ACS patients with high acute stress disorder symptoms at discharge, and assess FoR and future time perspective at inpatient bedside, then train participants on the IPad intervention. Participants will complete the intervention over four weeks in eight half-hour sessions, twice each week. Medication adherence will be measured electronically using eCAPS. We will reassess FoR and future time perspective at 1 month follow up, as well as electronically assess cognitive-affective change throughout the intervention period. We will estimate associations among ACS-induced PTSD, FoR, and future time perspective, and their association with medication adherence. Then, we will assess whether the intervention successfully engages the target mechanism (FoR). Finally, we will test whether the intervention improves adherence in the 2 months after hospital discharge, and whether any intervention effect is due to reduction in FoR. This will be the first study to identify, and perhaps modify, a cognitive/affective mechanism of adherence behavior in ACS patients at high risk for ACS recurrence and mortality.

急性冠状动脉综合征（ACS;心肌梗死或不稳定型心绞痛）是导致心绞痛的主要原因。 发病率和死亡率，每年超过100万例。幸存者有很高的风险， 复发性心血管疾病（CVD）事件，特别是如果他们不遵守风险- 减少药物。不幸的是，ACS患者的不依从性非常普遍 （约50%），没有有效的、可扩展的干预措施。解决药物治疗不依从性 ACS患者需要实验医学方法来确定ACS的具体机制 这些机制对人群最相关和最可改变的行为改变。 越来越多的证据表明，许多患有创伤后应激障碍的患者 ACS后的创伤后应激障碍（PTSD）症状将他们的药物视为他们心脏疾病的提醒。 以及未来的CVD风险。具有讽刺意味的是，尽管它很少被研究癌症以外的 对于ACS幸存者来说，这种对复发的恐惧（FoR）可能会破坏ACS患者的药物依从性。 该项目将使用行为改变科学（SOBC）实验医学方法， 研究FoR作为阿司匹林依从性行为改变假定机制 出院时出现早期创伤后应激障碍症状的ACS患者中。我们将测试认知- 情感干预已被证明可以降低癌症幸存者的FoR， 在患者家中使用电子设备（iPad）。我们已经开始为ACS调整这种干预措施， 并将采用双盲随机对照设计进行测试。我们将入组n=100例ACS 出院时急性应激障碍症状严重的患者，并评估FoR和未来时间 在住院病人床边的观点，然后培训参与者的iPad干预。参与者 将在四周内完成八次半小时的干预，每周两次。 将使用eCAPS以电子方式测量药物依从性。我们将重新评估FoR， 1个月随访时的未来时间观念，以及电子评估认知-情感 在整个干预期间发生变化。 我们将评估ACS诱导的PTSD、FoR和未来时间洞察力之间的关联， 与药物依从性的关系。然后，我们将评估干预是否 成功接合目标机制（FoR）。最后，我们将测试干预是否 改善出院后2个月的依从性，以及是否有任何干预 影响是由于FoR的降低。这将是第一个研究，以确定，也许修改， ACS高危患者依从行为的认知/情感机制 复发率和死亡率。