iPhone Helping Evaluate Atrial Fibrillation Rhythm through Technology (iHEART)

iPhone 通过技术帮助评估心房颤动心律 (iHEART)

• 批准号: 9278019
• 负责人: KATHLEEN T HICKEY
• 金额: $ 40万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9278019
• 关键词: Address; Adherence; Affect; American; Arrhythmia; Atrial Fibrillation; Behavior; Behavioral; Blood Pressure; Cardiac; Cardiac health; Cardiovascular Diseases; Cardiovascular system; Caring; Cellular Phone; Chronic; Chronic Disease; Clinical; Communication; Control Groups; Coupled; Cox Proportional Hazards Models; Detection; Development; Diabetes Mellitus; Early Diagnosis; Early treatment; Effectiveness; Elderly; Electric Countershock; Electrocardiogram; Enrollment; Epidemic; European; Evaluation; Foundations; Future; Glucose; Goals; Growth; Guidelines; Health Personnel; Health Promotion; Health Technology; Healthcare; Heart; Heart Diseases; Heart failure; Hispanics; Hypertension; Individual; Intervention; Knowledge; Lead; Linear Regressions; Measures; Medical; Medicare; Methods; Modeling; Monitor; Motivation; Outcome; Patient Education; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Population; Prevalence; Provider; Public Health; Quality of life; Quality-Adjusted Life Years; Questionnaires; Randomized; Randomized Controlled Trials; Recording of previous events; Recurrence; Regimen; Research; Risk Factors; Self Management; Severities; Side; Societies; Stroke; Symptoms; Technology; Testing; Text; Time; Underserved Population; behavioral outcome; cardiovascular health; clinical care; disorder prevention; global health; group intervention; healthy lifestyle; heart rhythm; improved; mHealth; multiple chronic conditions; novel strategies; public health relevance; response; tool; transmission process

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.

描述（由申请人提供）：心房颤动（AF）是一个主要的全球健康问题；事实上，未经识别和治疗的房颤可能会导致中风和其他不良心脏后果。这项研究的长期目标是利用 mHealth 心脏监测技术来检测是否存在复发性 AF，并改善自我管理行为和患者治疗结果。将总共​​招募 300 名有 AF 病史（在过去 30 天内接受过 AF 治疗）的受试者。受试者将被随机分组​​接受 iHEART 干预、配备心电图监测功能和教育短信的 iPhone(R) (n=150) 或常规心脏护理 bb（对照组）(n=150)，为期 6 个月。该研究的目的是： 目标 1：与常规心脏护理（对照组）相比，检查 mHealth 心电图技术（iHEART 干预）在检测和治疗复发性 AF 方面的功效。 � 目标 2：评估 iHEART 干预组与对照组在基线和 6 个月之间的质量调整生命年 (QALY)。 目标 3：确定 6 个月内改变行为、激励短信对慢性心血管疾病（例如高血压、糖尿病）和 AF 知识的影响。 除了接受常规的心脏护理外，随机分配到 iHEART 干预组的患者还将每天或在出现症状时记录单通道心电图条，这些症状可以通过快速细胞传输发送给提供者和研究团队。接受 iHEART 干预的患者还将每周收到 3 次改变行为的激励短信。 将确定每组在 6 个月的研究期间复发性 AF 的检出率以及针对 AF 管理的后续治疗。此外，将在基线和 6 个月时对两组患者进行心房颤动对生活质量的影响 (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心房颤动严重程度 (CSS-AF) 问卷，以评估生活质量、QALY 和房颤知识的差异。在目标 1 中，将使用多元泊松回归来计算两组之间检测到的 AF 比例的差异。我们将应用 Cox 比例风险模型来检查和测试各组之间治疗时间的差异，并调整其他潜在的混杂因素。在目标 2 中，我们将使用双边 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 QALY、QoL 和 CCS-SAF 评分。在目标 3 中，短信对心脏结果和 AF 知识的影响将通过双边 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图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移动医疗干预措施奠定基础。