iPhone Helping Evaluate Atrial Fibrillation Rhythm Through Technology

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.

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.