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Randomized Controlled Trial
. 2022 Nov;65(2):453-460.
doi: 10.1007/s10840-022-01235-8. Epub 2022 May 5.

Prospective evaluation of the effect of smartphone electrocardiogram usage on anticoagulant medication compliance

Andy T Tran  1   2   3 , Osama M Okasha  1   2 , Daniel A Steinhaus  1 , Omair K Yousuf  1 , Michael J Giocondo  1 , Brian M Ramza  1 , Alan P Wimmer  1   2 , Sanjaya K Gupta  4   5
Affiliations
Randomized Controlled Trial

Prospective evaluation of the effect of smartphone electrocardiogram usage on anticoagulant medication compliance

Andy T Tran et al. J Interv Card Electrophysiol. 2022 Nov.

Abstract

Purpose: Compliance with anticoagulation treatment for atrial fibrillation is highly variable. Smartphone electrocardiograms that allow patients to have greater insight into their arrhythmia burden may improve anticoagulant compliance.

Methods: Patients were enrolled if they had atrial fibrillation with a CHA2DS2-VASc score of 2 or more, were eligible for anticoagulation and had a smartphone. Participants were randomly assigned to receive a smartphone electrocardiogram (AliveCor Kardia) to record their electrocardiograms 5 times/week or to the control group. All patients received 6 months of anticoagulant (apixaban) dispensed as 1-month pre-loaded pill boxes.

Results: A total of 100 patients were enrolled from July 2017 to August 2019, but 5 patients in the monitor arm and 1 in the control arm withdrew prematurely. The monitor and control groups did not differ in age, gender, CHA2DS2-VASc score, or comorbidities. Median medication compliance was 99.7%, with nonsignificantly greater compliance in the monitor group (100%) than in the control group (99.7%) (p-value = 0.247). There was also no significant difference between missing any dose and use/nonuse of the smartphone monitor (48.9% vs. 55.1%; p-value = 0.692). Mean monitor compliance was 86.8% ± 14.0% with an average of 4.34 recorded electrocardiograms per week. Monitor group patients with perfect medication compliance had significantly higher monitor compliance than those patients who missed doses (median 95.3% vs 86.7%; p-value = 0.02).

Conclusions: In a study population with higher-than-expected medication compliance, the use of smartphone electrocardiogram did not demonstrate an improvement in medication compliance as compared to usual care. Greater monitor compliance was associated with greater medication compliance.

Clinical trial registration: BOAT-OAR ClinicalTrials.gov number, NCT03515083.

Keywords: Adherence; Anticoagulation; Atrial Fibrillation; Clinical trials; New Technology.

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