Clinical trial NCT02731326: iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology
Official title: iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Atrial fibrillation (AF), a condition where the top chambers of the heart beat irregularly, is a major health problem. The long-term goal of this project is to use a personal, mobile heart monitor to help patients better recognize recurrent AF and improve patients' ability to better manage their condition. A total of 300 patients with a history of AF will be included in the study, with 150 patients receiving an iPhone with the mobile monitoring device and educational text messaging and the remaining 150 patients continuing with their regular medical care. Each patient will be included in the intervention period for 6 months. The rate of recurrent AF and treatments meant to manage AF and other heart conditions will be determined for both groups. Patients in both groups will complete a series of questionnaires at the start and end of the 6 month study period to look at differences in quality of life and knowledge of AF.

Detailed description: This study is a prospective randomized control trial with 1:1 randomization of 300 patients to either use the AliveCor device and receive behavioral altering motivational text messaging OR continue with usual care. The sample size and power was based on the test of the difference in AF detection rates between the intervention group and the control group in a similarly design pilot study. In the preliminary data there were 4 episodes of AF during the follow-up of 12 patients or a detection rate of 0.33 vs. a detection rate of 8% among controls. The detection window in this study as the time period from randomization to the 6-month follow-up will be defined. All patients' clinical records will be reviewed every month (via charts and/or internal and external electronic medical record systems) up until month 6 for initiations/changes in treatments targeting AF. A recurrence of AF in the chart and any related therapies that are initiated as a result of electrocardiogram (ECG) findings through usual cardiac care or from the AliveCor™ Heart Monitor will be specifically looked at. Changes in cardiovascular measures (blood pressure, glucose control, etc.) will be compared between groups. The effect of participating in the intervention, which includes targeted text messaging on AF knowledge and cardiovascular behavior change will be determined by comparing the change in AF knowledge scales from baseline to 6 months. This study will also measure and compare the incidence of documented AF in both groups, changes in prescribed treatment by healthcare providers over the 6-month period, and the relationship of the intervention to changes in cardiac measures and quality-adjusted life-years (QALYs) measured at baseline and 6 months. A biannual time period was chosen to capture AF redetection, changes in AF treatment, and self-reported quality of life based on other studies that have shown biannual time-points as most appropriate for collecting the proposed study endpoints.

Eligibility criteria: Inclusion Criteria:

* Males and females (English or Spanish speaking) age ≥ 18 years with a history of AF in the last 30 days that was treated with normal rhythm restored.
* Ability to successfully use the AliveCor™ Heart Monitor, capture a baseline ECG, and transmit on the day of enrollment
* Demonstrated ability to receive, read, and send a text messages on the day of enrollment
* Willingness to complete the study questionnaires at baseline and 6 months

Exclusion Criteria:

* Documented permanent (chronic) AF
* Patient found to be in AF or other rhythm disturbances on the day of enrollment (i.e., they need to be clinically evaluated or treated)
* Unwillingness have their clinical data collected over the study period
* Unwillingness to receive and read cardiovascular text messaging three times a week.

Primary outcomes:
measure: Rate of Recurrence of Atrial Arrhythmias
timeFrame: Six months
measure: Time to Treatment for Recurrence of Atrial Arrhythmia
timeFrame: Six months
measure: Number of Intervention and Control Group Patients Treated for Recurrent Atrial Arrhythmia
timeFrame: 6 months
Secondary outcomes:
measure: Difference in Quality-Adjusted Life Years (QALYS) Between Intervention and Control Groups
timeFrame: Six Months
measure: Change in Atrial Fibrillation Knowledge Scale (AFKS) Scores Between Baseline and Six Months
timeFrame: Six months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Suzanne Bakken, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Goldenthal IL, Sciacca RR, Riga T, Bakken S, Baumeister M, Biviano AB, Dizon JM, Wang D, Wang KC, Whang W, Hickey KT, Garan H. Recurrent atrial fibrillation/flutter detection after ablation or cardioversion using the AliveCor KardiaMobile device: iHEART results. J Cardiovasc Electrophysiol. 2019 Nov;30(11):2220-2228. doi: 10.1111/jce.14160. Epub 2019 Sep 25.
citation: Koleck TA, Mitha SA, Biviano A, Caceres BA, Corwin EJ, Goldenthal I, Creber RM, Turchioe MR, Hickey KT, Bakken S. Exploring Depressive Symptoms and Anxiety Among Patients With Atrial Fibrillation and/or Flutter at the Time of Cardioversion or Ablation. J Cardiovasc Nurs. 2021 Sep-Oct 01;36(5):470-481. doi: 10.1097/JCN.0000000000000723.
citation: Caceres BA, Hickey KT, Bakken SB, Biviano AB, Garan H, Goldenthal IL, Koleck TA, Masterson-Creber R, Turchioe MR, Jia H. Mobile Electrocardiogram Monitoring and Health-Related Quality of Life in Patients With Atrial Fibrillation: Findings From the iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology (iHEART) Study. J Cardiovasc Nurs. 2020 Jul/Aug;35(4):327-336. doi: 10.1097/JCN.0000000000000646.