iPhone Helping Evaluate Atrial Fibrillation Rhythm through Technology (iHEART)

描述(申请人提供)：房颤(房颤)是一个主要的全球健康问题；事实上，未被识别和治疗的房颤可能导致中风和其他不利的心脏后果。这项研究的长期目标是使用mHealth心脏监测技术来检测复发的房颤的存在，并改善自我管理行为和患者预后。总共有300名有房颤病史(在过去30天内接受过房颤治疗)的受试者将被登记。受试者将被随机分成两组，接受iHeart干预，接受配备了心电监测功能和教育短信的iPhone(注册商标)(n=150)，或接受普通心脏护理BB(控制组)(n=150)，为期6个月。这项研究的目的是：�目标1：与常规心脏护理(对照组)相比，检查mHealth心电技术(i心脏干预)在检测和治疗复发房颤方面的效果。�目标2：评估与对照组在基线和6个月期间的质量调整寿命年(QALY)。�目标3：确定6个月内行为改变、激励性短信对慢性心血管疾病(例如高血压、糖尿病)和房颤知识的影响。除了接受常规的心脏护理外，那些被随机分配到iHeart干预组的人将每天或在症状设置中记录一条单通道心电条，这些症状可以通过快速的蜂窝传输发送给提供者和研究团队。接受i心脏干预的患者还将每周三次收到行为改变的激励性短信。将确定每一组在6个月的研究期内针对房颤复发和后续治疗的发现率。此外，房颤对生活质量的影响(AFEQT)、欧洲生活质量量表(EQ5D)、房颤知识量表和加拿大心血管学会房颤严重程度问卷将在基线和6个月时对两组进行问卷调查，以评估QL、QALY和房颤知识的差异。在目标1中，将使用多变量Poisson回归来计算两组之间检测到的房颤比例的差异。我们将应用COX比例风险模型来检验和测试两组之间治疗时间的差异，并对其他潜在的混杂因素进行调整。在目标2中，我们将使用双侧t检验和多元线性回归模型比较iHeart干预组和对照组之间的QALYS、QOL和CCS-SAF得分。在目标3中，短信对心脏结局和房颤知识的影响将通过双侧t检验和线性混合模型(增长模型)来确定。该项目可能会改变现有的心电监测和患者教育指南，并为使用旨在改善健康促进、生活质量和疾病预防的mHealth干预措施奠定基础。

DESCRIPTION (provided by applicant): Atrial fibrillation (AF) is a major global health problem; in fact, unrecognized and untreated AF can lead to stroke and other adverse cardiac outcomes. The long-term goal of this research is to use mHealth cardiac monitoring technology to detect the presence of recurrent AF and improve self-management behaviors and patient outcomes. A total of 300 subjects with a prior history of AF (treated for AF in the last 30 days) will be enroled. Subjects will be randomized in equal numbers to receive the iHEART intervention, receiving an iPhone(R) equipped with ECG monitoring capabilities and educational text messaging (n=150), or usual cardiac care bb(control group) (n=150) for 6 months. The study aims are to: � Aim 1: Examine the efficacy of mHealth ECG technology (iHEART intervention) on the detection and treatment of recurrent AF as compared to usual cardiac care (control group). � Aim 2: Evaluate the quality-adjusted life-years (QALYs) in those in the iHEART intervention as compared to the control group between baseline and 6 months. � Aim 3: Determine the impact of behavior altering, motivational text messages on chronic cardiovascular conditions (e.g., hypertension, diabetes) and AF knowledge over 6 months. In addition to receiving usual cardiac care, those randomized to the iHEART intervention group will record a single channel ECG strip daily or in the setting of symptoms which can be sent via rapid cellular transmission to providers and the study team. Patients in the iHEART intervention will also receive behavior altering, motivational text messages three times a week. The detection rate for recurrent AF and subsequent treatments aimed at AF management over the 6-month study period in each of the groups will be determined. In addition, the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT), European Quality of Life Scale (EQ5D), AF Knowledge Scale, and Canadian Cardiovascular Society Severity in Atrial Fibrillation (CSS-AF) questionnaires will be administered to both groups at baseline and 6 months to assess differences in QoL, QALYs, and AF knowledge. In Aim 1, the difference in proportions of AF detected between both groups will be performed using multivariate Poisson regression. We will apply a Cox proportional hazard model to examine and test the difference in the time-to-treatment between the groups with the adjustment for other potential confounders. In Aim 2, we will compare QALYs, QoL, and CCS-SAF scores between the iHEART intervention group and the control group using a two-sided t-test and multivariate linear regression models. In Aim 3, the effect of text messaging on cardiac outcomes and AF knowledge will be determined by a two-sided t-test and a linear mixed model (growth model). This project may change existing guidelines for how ECG monitoring and patient education are approached and lay the foundation for using mHealth interventions aimed at improving health promotion, QoL, and disease prevention.