title: 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.
abstract: 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.
authors.affiliation: Columbia University School of Nursing, 622 W. 168th St., New York, NY, 10032, USA. kth6@columbia.edu.
authors.forename: Kathleen T
authors.initials: KT
authors.lastname: Hickey
authors.affiliation: Columbia University Medical Center, 630 W. 168th St., New York, NY, 10032, USA.
authors.forename: Nicole R
authors.initials: NR
authors.lastname: Hauser
authors.affiliation: Columbia University School of Nursing, 622 W. 168th St., New York, NY, 10032, USA.
authors.forename: Laura E
authors.initials: LE
authors.lastname: Valente
authors.affiliation: Columbia University Medical Center, 630 W. 168th St., New York, NY, 10032, USA.
authors.forename: Teresa C
authors.initials: TC
authors.lastname: Riga
authors.affiliation: Columbia University Medical Center, 630 W. 168th St., New York, NY, 10032, USA.
authors.forename: Ashton P
authors.initials: AP
authors.lastname: Frulla
authors.affiliation: Columbia University School of Nursing, 622 W. 168th St., New York, NY, 10032, USA.
authors.forename: Ruth
authors.initials: R
authors.lastname: Masterson Creber
authors.affiliation: Columbia University Medical Center, 630 W. 168th St., New York, NY, 10032, USA.
authors.forename: William
authors.initials: W
authors.lastname: Whang
authors.affiliation: Columbia University Medical Center, 630 W. 168th St., New York, NY, 10032, USA.
authors.forename: Hasan
authors.initials: H
authors.lastname: Garan
authors.affiliation: Columbia University School of Nursing, 622 W. 168th St., New York, NY, 10032, USA.
authors.forename: Haomiao
authors.initials: H
authors.lastname: Jia
authors.affiliation: Columbia University School of Nursing, 622 W. 168th St., New York, NY, 10032, USA.
authors.forename: Robert R
authors.initials: RR
authors.lastname: Sciacca
authors.affiliation: Columbia University Medical Center, 630 W. 168th St., New York, NY, 10032, USA.
authors.forename: Daniel Y
authors.initials: DY
authors.lastname: Wang
mesh_terms: D000200:Action Potentials; D001281:Atrial Fibrillation / Q000175:diagnosis* / Q000503:physiopathology / Q000628:therapy; D002985:Clinical Protocols; D004562:Electrocardiography / Q000295:instrumentation* / Q000379:methods; D015438:Health Behavior; D007722:Health Knowledge, Attitudes, Practice; D000070497:Healthy Lifestyle; D006329:Heart Conduction System / Q000503:physiopathology*; D006339:Heart Rate; D006801:Humans; D063731:Mobile Applications; D009042:Motivation; D009519:New York City; D010353:Patient Education as Topic; D011237:Predictive Value of Tests; D011446:Prospective Studies; D012107:Research Design; D040242:Risk Reduction Behavior; D012648:Self Care; D012815:Signal Processing, Computer-Assisted; D000068997:Smartphone; D017216:Telemedicine / Q000295:instrumentation* / Q000379:methods; D060145:Text Messaging
keywords: Atrial fibrillation; Electrocardiogram; Mobile health; Quality of life; Quality-adjusted life years; Self-management; Smartphone