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

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Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

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.

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Data availability

The data that support the findings of this study are available on Synapse.

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Acknowledgements

We acknowledge Kelley Gasperi RN, Tina Baker RN and Jackie Smith RN for their efforts to recruit patients and maintain records throughout this study.

Funding

This study was funded by Bristol Myers Squibb-Pfizer Alliance and AliveCor; BOAT-OAR ClinicalTrials.gov number, NCT03515083).

Author information

Authors and Affiliations

  1. Cardiovascular Research, Saint Luke’s Mid America Heart Institute, 4401 Wornall Rd, 9th Floor, Kansas City, 64111, MO, USA

    Andy T. Tran, Osama M. Okasha, Daniel A. Steinhaus, Omair K. Yousuf, Michael J. Giocondo, Brian M. Ramza, Alan P. Wimmer & Sanjaya K. Gupta

  2. Department of Medicine, University of Missouri–Kansas City, School of Medicine, Kansas City, MO, USA

    Andy T. Tran, Osama M. Okasha, Alan P. Wimmer & Sanjaya K. Gupta

  3. Department of Medicine, University of California, Irvine School of Medicine, CA, Orange, USA

    Andy T. Tran

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  1. Andy T. Tran
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Contributions

Andy T. Tran, DO did data analysis/interpretation, drafting article, critical revision of article, approval of article, statistics, data collection and others.

Osama M. Okasha, MD was involved in data analysis/interpretation, critical revision of article, approval of article, data collection and others.

Daniel A. Steinhaus, MD, Omair K. Yousuf, MD, Michael J. Giocondo, MD, Brian M. Ramza, MD, PhD, and Alan P. Wimmer, MD performed concept/design, data analysis/interpretation, critical revision of article, approval of article, statistics and others.

Sanjaya K. Gupta, MD was involved in concept/design, securing funding, data analysis/interpretation, drafting article, critical revision of article, approval of article, statistics, and data collection.

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Andy Tran, DO and Osama Okasha, MD and Sanjaya Gupta, MD. The first draft of the manuscript was written by Andy Tran, DO, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Sanjaya K. Gupta.

Ethics declarations

Ethics approval statement

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

The study was approved by Saint Luke’s Mid America Heart Institute Institutional Review Board, IRB #17–043.

Patient consent statement

Written informed consent was obtained from all individual participants included in the study.

Permission to reproduce material from other sources

Permission granted.

Conflict of interest disclosure

Dr. Tran reported receiving grants from the National Heart, Lung, and Blood Institute of the National Institutes of Health T32 training grant T32HL110837 during the conduct of the study. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Dr. Wimmer and Dr. Steinhaus receive speaker’s honoraria from Boston Scientific. Dr. Gupta receives research support from Medtronic, Abbott, Bristol Myers Squibb-Pfizer Alliance and has consulted for Medtronic, Boston Scientific and Respicardia. None of these disclosures were related to this research and should not represent a potential conflict of interest related to this manuscript.

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Tran, A., Okasha, O., Steinhaus, D. et al. Prospective evaluation of the effect of smartphone electrocardiogram usage on anticoagulant medication compliance. J Interv Card Electrophysiol 65, 453–460 (2022). https://doi.org/10.1007/s10840-022-01235-8

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  • DOI: https://doi.org/10.1007/s10840-022-01235-8

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