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

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

Gerontechnologies for Older Patients with Heart Failure: What is the Role of Smartphones, Tablets, and Remote Monitoring Devices in Improving Symptom Monitoring and Self-Care Management?

“…Rather, rapid, real time capture of an ECG can occur immediately at the onset of symptoms, which can provide a significant improvement for symptom evaluation. The efficacy of Kardia™ Mobile on patient reported and clinical outcomes is currently being tested in the iHEART randomized controlled trial (Clinicaltrials.gov ID: NCT02731326) [44]. …”

Rationale and design of the Atrial Fibrillation health Literacy Information Technology Trial: (AF-LITT)

“…[9] Implementation of mobile devices may provide an opportunity to address the challenges described here and aim to improve outcomes in vulnerable individuals with AF. While smartphone-based technologies are effective for screening and monitoring AF, [10,11] the data regarding their use to address adherence and HRQoL in AF remain sparse.…”

“…The Kardia is a smartphone-based app that allows users to obtain heart rhythm and rates and is FDA-approved for enhanced detection and management of AF. [10,11,16,17] As a preliminary assessment, we combined the ECA and the Kardia to test their utility in 31 individuals with chronic AF. We developed ECA content to prompt use of the Kardia for symptoms, intending to provide valuable correlation between symptoms and heart rate and rhythm.…”

Smartphone electrocardiogram monitoring: current perspectives

“…This is a randomized controlled trial to determine whether AF patients who utilize the Kardia Mobile smartphone ECG have greater improvement in markers such as blood pressure and glucose levels as well as improved AF awareness compared to patients who receive usual care defined by published guidelines. 20,23 If positive, this would be the first trial showing improved health measures when ECG smartphone technology is utilized.…”