Hickey Kathleen T, Hauser Nicole R, Valente Laura E, Riga Teresa C, Frulla Ashton P, Masterson Creber Ruth, Whang William, Garan Hasan, Jia Haomiao, Sciacca Robert R, Wang Daniel Y
Columbia University School of Nursing, 622 W. 168th St., New York, NY, 10032, USA.
Columbia University Medical Center, 630 W. 168th St., New York, NY, 10032, USA.
BMC Cardiovasc Disord. 2016 Jul 16;16:152. doi: 10.1186/s12872-016-0327-y.
Atrial fibrillation is a major public health problem and is the most common cardiac arrhythmia, affecting an estimated 2.7 million Americans. The true prevalence of atrial fibrillation is likely underestimated because episodes are often sporadic; therefore, it is challenging to detect and record an occurrence in a "real world" setting. To date, mobile health tools that promote earlier detection and treatment of atrial fibrillation and improvement in self-management behaviors and knowledge have not been evaluated. This study will be the first to address the epidemic problem of atrial fibrillation with a novel approach utilizing advancements in mobile health electrocardiogram technology to empower patients to actively engage in their healthcare and to evaluate impact on quality of life and quality-adjusted life years. Furthermore, sending a daily electrocardiogram transmission, coupled with receiving educational and motivational text messages aimed at promoting self-management and a healthy lifestyle may improve the management of chronic cardiovascular conditions (e.g., hypertension, diabetes, heart failure, etc.). Therefore, we are currently conducting a randomized controlled trial to assess the efficacy of a mobile health intervention, iPhone® Helping Evaluate Atrial fibrillation Rhythm through Technology (iHEART) versus usual cardiac care.
The iHEART study is a single center, prospective, randomized controlled trial. A total of 300 participants with a recent history of atrial fibrillation will be enrolled. Participants will be randomized 1:1 to receive the iHEART intervention, receiving an iPhone® equipped with an AliveCor® Mobile ECG and accompanying Kardia application and behavioral altering motivational text messages or usual cardiac care for 6 months.
This will be the first study to investigate the utility of a mobile health intervention in a "real world" setting. We will evaluate the ability of the iHEART intervention to improve the detection and treatment of recurrent atrial fibrillation and assess the intervention's impact on improving clinical outcomes, quality of life, quality-adjusted life-years and disease-specific knowledge.
NCT02731326 ; Verified April 2016.
心房颤动是一个重大的公共卫生问题，也是最常见的心律失常，据估计影响着270万美国人。心房颤动的实际患病率可能被低估了，因为发作往往是零星的；因此，在“现实世界”环境中检测和记录其发生具有挑战性。迄今为止，尚未对促进心房颤动早期检测和治疗以及改善自我管理行为和知识的移动健康工具进行评估。本研究将首次采用一种新颖的方法来解决心房颤动这一流行问题，该方法利用移动健康心电图技术的进步，使患者能够积极参与自身医疗保健，并评估其对生活质量和质量调整生命年的影响。此外，每天发送心电图传输数据，再加上接收旨在促进自我管理和健康生活方式的教育性和激励性短信，可能会改善慢性心血管疾病（如高血压、糖尿病、心力衰竭等）的管理。因此，我们目前正在进行一项随机对照试验，以评估一种移动健康干预措施——通过技术帮助评估心房颤动节律的iPhone®（iHEART）与常规心脏护理的疗效。
iHEART研究是一项单中心、前瞻性、随机对照试验。总共将招募300名近期有心房颤动病史的参与者。参与者将按1:1随机分组，接受iHEART干预，即获得一部配备了AliveCor®移动心电图和配套的Kardia应用程序以及行为改变激励短信的iPhone®，或接受常规心脏护理，为期6个月。
这将是第一项在“现实世界”环境中研究移动健康干预措施效用的研究。我们将评估iHEART干预措施改善复发性心房颤动检测和治疗的能力，并评估该干预措施对改善临床结局、生活质量、质量调整生命年和疾病特定知识的影响。
NCT02731326；2016年4月核实。
