Investigating Fear Of Recurrence as a Modifiable Mechanism of Behavior Change to Improve Medication Adherence in Acute Coronary Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in Total Score for Concerns About Recurrence Scale [Adapted for Acute Coronary Syndrome]
研究概览
简要总结
The primary goal of this project is to identify, measure, and influence fear of cardiac event recurrence, a candidate mechanism of change in medication adherence in patients with suspected acute coronary syndrome (ACS). An intervention will be tested that has been used to reduce fear of cancer recurrence by changing emotion-related patterns of attention allocation and interpretation of neutral stimuli. Secondarily, the study will test whether a reduction in fear of cardiac event recurrence improves medication adherence.
详细描述
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 heart medication adherence among ACS patients with early PTSD symptoms at hospital discharge. The study will test a cognitive-affective intervention that has been shown to reduce FoR in cancer survivors, that is delivered electronically (electronic tablet) in the patient's home. The intervention has been adapted in this study for ACS to be tested using a double-blind randomized controlled design. One hundred suspected ACS patients will be enrolled who reported at least mild to moderate threat perceptions at the time of their initial visit to the emergency department. FoR and future time perspective will be assessed within six weeks of the initial visit to the emergency department, and then participants will be trained on the tablet intervention. Participants will complete the intervention over four weeks in eight half-hour sessions, twice each week. Medication adherence will be measured electronically using eCAP devices. FoR and future time perspective will be reassessed 1 month after the baseline session, and cognitive-affective change will be assessed electronically throughout the intervention period.
In addition to investigating FoR as the primary mechanism of behavior change, the study also investigates a secondary potential mechanism that is a distinct, but related, construct: future time perspective. Furthermore, in addition to examining medication adherence as the primary health behavior of interest, the study also examines a secondary health behavior that is reduced in fearful cardiac patients: physical activity. Collectively, the three aims below address these two putative mechanisms (FoR, future time perspective) and these two health behaviors (medication adherence, physical activity) in the randomly assigned groups (intervention, control).
Objectives
Aim 1 (main purpose of the trial):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older;
- •Fluent in English or Spanish;
- •A diagnosis of NSTEMI or unstable angina (UA) according to American College of Cardiology criteria;
- •Currently enrolled in the protocol titled "Testing biopsychosocial mechanisms of the posthospital syndrome [PHS] model of early rehospitalization in cardiac patients" (IRB-AAAR7350 at CUIMC)
- •Previously indicated "YES" to the following question in the consent form for the separate protocol (IRB-AAAR7350) in which they are enrolled and willing to be contacted about other future research projects.
- •Elevated Threat Perception score in emergency department flagged by automatic scoring (i.e., ≥ 10, the median for 1,000 ACS patients in a separate sample)
- •Currently on a daily aspirin regimen prescribed by a doctor OR currently on a daily beta-blocker or statin regimen prescribed by a doctor
- •Some comfort using technology such as electronic tablets or smartphones
排除标准
- •Deemed unable to comply with the protocol (either self-selected or by indicating during screening that s/he could not complete all requested tasks). This includes patients with a level of cognitive impairment indicative of dementia and patients with current alcohol or substance abuse;
- •Deemed to need immediate psychiatric intervention (that is, has to be hospitalized or have some other psychiatric intervention within 72 hours);
- •Unavailable for follow-up. This includes patients with a terminal noncardiovascular illness (life expectancy less than 1 year by physician report) and those who indicate they are about to leave the United States;
- •Underwent a surgical procedure within the past 24 hours and/or is scheduled for a surgical procedure within the next 24 hours.
结局指标
主要结局
Change in Total Score for Concerns About Recurrence Scale [Adapted for Acute Coronary Syndrome]
时间窗: Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart)
This 19-item self-report scale measures fear of recurrence of ACS events. It uses a 5-point Likert scale (0 to 4). It has three subscales: health worries (items 1-11; subscale range: 0-44), role worries (items 12-17: subscale range: 0-24), and death worries (items 18-19: subscale range: 0-8). The total score is computed as the sum of all items in the scale (total score range: 0 to 76). Higher total scores indicate greater fear of recurrence. The study will test whether there is a larger Time-1-to-Time-2 reduction in Concerns about Recurrence total scores for the intervention group relative to the control group. The outcome for each group is computed as mean of the difference of the Time-2 score minus the Time-1 score. This is the sole primary outcome because the trial design was statistically powered to reduce FoR.
次要结局
- Change in Total Score for Future Time Perspective Scale(Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart))
- Change in Total Score for the International Physical Activity Questionnaire in MET Minutes/Week(Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart))
- Total Score for Self-reported Extent of Nonadherence to Medication From the Extent of and Reasons for Nonadherence Scale [Adapted](Post-Training/Time 2 (approximately 4 weeks after Time 1))
- Change in Cue Presence Score for the Context Sensitivity Index(Pre-Training/Time 1, Post-Training/Time 2 (approximately 4 weeks apart))
- Percentage of Adherent Days to Medication (Aspirin, Beta-blocker, or Statin)(Up to 2 months (starting after Pre-Training/Time 1 and extending for approximately 4 weeks after Post-Training/Time 2))
研究者
Jeffrey Birk
Instructor in Medical Sciences
Columbia University