A single-center randomized, controlled trial investigating the efficacy of a mHealth ECG technology intervention to improve the detection of atrial fibrillation: the iHEART study protocol

BMC Cardiovascular Disorders

Study Protocol

Nicole R. Hauser¹  Teresa C. Riga¹  Ashton P. Frulla¹  Daniel Y. Wang¹  Hasan Garan¹  William Whang¹  Kathleen T. Hickey²  Haomiao Jia²  Ruth Masterson Creber²  Laura E. Valente²  Robert R. Sciacca² 

[1] Columbia University Medical Center, 630 W. 168th St., 10032, New York, NY, USA;Columbia University School of Nursing, 622 W. 168th St., 10032, New York, NY, USA;

关键词: Atrial fibrillation;    Electrocardiogram;    Smartphone;    Quality of life;    Mobile health;    Self-management;    Quality-adjusted life years;   

DOI  :  10.1186/s12872-016-0327-y

 received in 2016-04-20, accepted in 2016-06-22,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundAtrial 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.MethodsThe 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.DiscussionThis 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.Trial registrationNCT02731326; Verified April 2016

【 授权许可】

CC BY   
© The Author(s). 2016