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: 8669493
• 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/8669493
• 关键词: Address; Adherence; Affect; American; Arrhythmia; Atrial Fibrillation; Behavior; Behavioral; Blood Pressure; Cardiac; Cardiovascular Diseases; Cardiovascular system; Caring; 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; Health Personnel; Health Promotion; Health Technology; Healthcare; Heart; Heart failure; Hispanics; Hypertension; Individual; Intervention; Knowledge; Lead; Life; Life Style; Linear Regressions; Measures; Medical; Medicare; Methods; Modeling; Monitor; Outcome; Patient Education; 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; clinical care; disorder prevention; empowered; global health; group intervention; heart rhythm; hypertensive heart disease; improved; mHealth; multiple chronic conditions; novel strategies; public health relevance; response; tool; transmission process

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 enrolled. 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 (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.

心房颤动（AF）是一个主要的全球健康问题;事实上，未被识别和未经治疗的AF可导致 中风和其他不良心脏结局。这项研究的长期目标是使用mHealth心脏 监测技术，以检测复发性AF的存在并改善自我管理行为， 患者结局。共有300例有AF既往史的受试者（在过去30天内接受AF治疗）将接受 注册了受试者将以相同数量随机分配接受iHEART干预， 配备ECG监测功能和教育短信的iPhone（R）（n=150），或常规心脏 对照组（n=150）。研究的目的是： 目标1：检查mHealth ECG技术（iHEART干预）在检测和 与常规心脏护理（对照组）相比，复发性AF的治疗。 目标2：评估iHEART干预中的质量调整生命年（Qs）， 与对照组相比，基线和6个月之间。 目标3：确定行为改变，激励短信对慢性心血管疾病的影响 条件（例如，高血压、糖尿病）和AF知识超过6个月。 除了接受常规心脏护理外，随机分配到iHEART干预组的患者将记录 每天或在出现症状时使用单通道ECG条，可通过快速蜂窝传输发送 提供者和研究团队。iHEART干预中的患者也将接受行为改变， 一周发三次励志短信 6个月内复发性房颤的检出率和旨在房颤管理的后续治疗 将确定每组的研究时间。此外，房颤对生命质量的影响 （AFEQT）、欧洲生活质量量表（EQ 5D）、AF知识量表和加拿大心血管学会 将在基线和第6天对两组进行房颤严重程度（CSS-AF）问卷调查。 个月，以评估QoL、QOL和AF知识的差异。在目标1中，AF比例的差异 将使用多变量Poisson回归进行两组之间的检测。我们将应用一个考克斯 比例风险模型，以检查和检验组间至治疗时间的差异， 调整其他潜在混杂因素。在目标2中，我们将比较生活质量、生活质量和CCS-SAF评分 iHEART干预组和对照组之间使用双侧t检验和多变量线性 回归模型在目标3中，短信对心脏结局和AF知识的影响将是 通过双侧t检验和线性混合模型（生长模型）确定。该项目可能会改变现有的 如何进行ECG监测和患者教育的指南，并为使用 旨在改善健康促进、生活质量和疾病预防的移动健康干预措施。