Skip to main content

Advertisement

SpringerLink
Log in

Feasibility and usability of a mobile health tool on anticoagulation management for patients with atrial fibrillation: a pilot study

  • Pharmacoepidemiology and Prescription
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

Appropriate prescription of oral anticoagulants (OACs) and good patient adherence are essential to ensure optimal anticoagulation in patients with atrial fibrillation (AF). The aim of this study is to develop a mobile health tool to aid both clinicians and patients with AF in anticoagulation therapy.

Methods

In this study, a novel anticoagulation management model integrating decision support and patient follow-up, the I-Anticoagulation, was developed based on a WeChat Mini Program. With this tool, the risks of stroke and bleeding in AF patients can automatically be calculated according to their characteristics. Anticoagulation regimens were recommended based on a trade-off analysis that balances stroke and bleeding risks according to recent clinical guidelines. A shared decision can be made with full communication between medical professionals and patients. Moreover, follow-up was also conducted using I-Anticoagulation.

Results

A total of 120 AF patients receiving anticoagulants (40 received warfarin and 80 received non-vitamin K antagonist oral anticoagulants [NOACs]) were included in the pilot study. The incidence of thromboembolic events was 2.5% and 1.3%, and the rates of bleeding events were 22.5% and 13.8% in the warfarin and NOAC groups, respectively. Generally, self-reported adherence was high, and the satisfaction with anticoagulation was good in all patients with AF.

Conclusion

Overall, the anticoagulation management model developed in this study could be involved in the full process of anticoagulation therapy in AF patients to improve rationality, adherence, and satisfaction in both medical professionals and patients. However, the usability, feasibility, and acceptability of the I-Anticoagulant-based anticoagulation management model need to be further assessed through well-designed random clinical trials.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

Data availability

All data are available from the corresponding author on reasonable request.

References

  1. Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O’Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS, American Heart Association Council on E, Prevention Statistics C, Stroke Statistics S (2019) Heart disease and stroke statistics-2019 update: a report from the American Heart Association. Circulation 139(10):e56–e528. https://doi.org/10.1161/CIR.0000000000000659

    Article  PubMed  Google Scholar 

  2. Chugh SS, Havmoeller R, Narayanan K, Singh D, Rienstra M, Benjamin EJ, Gillum RF, Kim YH, McAnulty JH Jr, Zheng ZJ, Forouzanfar MH, Naghavi M, Mensah GA, Ezzati M, Murray CJ (2014) Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation 129(8):837–847. https://doi.org/10.1161/CIRCULATIONAHA.113.005119

    Article  PubMed  Google Scholar 

  3. Tawfik A, Bielecki JM, Krahn M, Dorian P, Hoch JS, Boon H, Husereau D, Pechlivanoglou P (2016) Systematic review and network meta-analysis of stroke prevention treatments in patients with atrial fibrillation. Clin Pharmacol 8:93–107. https://doi.org/10.2147/CPAA.S105165

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Vinereanu D, Lopes RD, Bahit MC, Xavier D, Jiang J, Al-Khalidi HR, He W, Xian Y, Ciobanu AO, Kamath DY, Fox KA, Rao MP, Pokorney SD, Berwanger O, Tajer C, de Barros ESPGM, Roettig ML, Huo Y, Granger CB, Investigators I-A (2017) A multifaceted intervention to improve treatment with oral anticoagulants in atrial fibrillation (IMPACT-AF): an international, cluster-randomised trial. Lancet 390(10104):1737–1746. https://doi.org/10.1016/S0140-6736(17)32165-7

    Article  PubMed  Google Scholar 

  5. Camm AJ, Cools F, Virdone S, Bassand JP, Fitzmaurice DA, Arthur Fox KA, Goldhaber SZ, Goto S, Haas S, Mantovani LG, Kayani G, Grierson Turpie AG, Antoon Verheugt FW, Kakkar AK, Investigators G-A (2020) Mortality in patients with atrial fibrillation receiving nonrecommended doses of direct oral anticoagulants. J Am Coll Cardiol 76(12):1425–1436. https://doi.org/10.1016/j.jacc.2020.07.045

    Article  CAS  PubMed  Google Scholar 

  6. Raparelli V, Proietti M, Cangemi R, Lip GY, Lane DA, Basili S (2017) Adherence to oral anticoagulant therapy in patients with atrial fibrillation. Focus on non-vitamin K antagonist oral anticoagulants. Thromb Haemost 117(2):209–218. https://doi.org/10.1160/TH16-10-0757

  7. Perreault S, de Denus S, White-Guay B, Cote R, Schnitzer ME, Dube MP, Dorais M, Tardif JC (2020) Oral anticoagulant prescription trends, profile use, and determinants of adherence in patients with atrial fibrillation. Pharmacotherapy 40(1):40–54. https://doi.org/10.1002/phar.2350

    Article  CAS  PubMed  Google Scholar 

  8. Yu HT, Yang PS, Jang E, Kim TH, Uhm JS, Kim JY, Pak HN, Lee MH, Lip GYH, Joung B (2020) Label adherence of direct oral anticoagulants dosing and clinical outcomes in patients with atrial fibrillation. J Am Heart Assoc 9(12):e014177. https://doi.org/10.1161/JAHA.119.014177

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Sanghai S, Wong C, Wang Z, Clive P, Tran W, Waring M, Goldberg R, Hayward R, Saczynski JS, McManus DD (2020) Rates of potentially inappropriate dosing of direct-acting oral anticoagulants and associations with geriatric conditions among older patients with atrial fibrillation: the SAGE-AF study. J Am Heart Assoc 9(6):e014108. https://doi.org/10.1161/JAHA.119.014108

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. Maura G, Pariente A, Alla F, Billionnet C (2017) Adherence with direct oral anticoagulants in nonvalvular atrial fibrillation new users and associated factors: a French nationwide cohort study. Pharmacoepidemiol Drug Saf 26(11):1367–1377. https://doi.org/10.1002/pds.4268

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Fedele DA, Cushing CC, Fritz A, Amaro CM, Ortega A (2017) Mobile health interventions for improving health outcomes in youth: a meta-analysis. JAMA Pediatr 171(5):461–469. https://doi.org/10.1001/jamapediatrics.2017.0042

    Article  PubMed  PubMed Central  Google Scholar 

  12. January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW (2019) 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in Collaboration With the Society of Thoracic Surgeons. Circulation 140(2):e125–e151. https://doi.org/10.1161/CIR.0000000000000665

    Article  PubMed  Google Scholar 

  13. Kunneman M, Branda ME, Hargraves IG, Sivly AL, Lee AT, Gorr H, Burnett B, Suzuki T, Jackson EA, Hess E, Linzer M, Brand-McCarthy SR, Brito JP, Noseworthy PA, Montori VM, Making SD, Shared Decision Making for Atrial Fibrillation Trial I (2020) Assessment of shared decision-making for stroke prevention in patients with atrial fibrillation: a randomized clinical trial. JAMA Intern Med 180(9):1215–1224. https://doi.org/10.1001/jamainternmed.2020.2908

    Article  PubMed  Google Scholar 

  14. Guo Y, Chen Y, Lane DA, Liu L, Wang Y, Lip GYH (2017) Mobile health technology for atrial fibrillation management integrating decision support, education, and patient involvement: mAF App trial. Am J Med 130(12):1388–1396 e1386. https://doi.org/10.1016/j.amjmed.2017.07.003

  15. Standardization Administration of the People's Republic of China (2020) Information security technology—personal information security specification. http://openstd.samr.gov.cn/bzgk/gb/newGbInfo?hcno=4568F276E0F8346EB0FBA097AA0CE05E. Accessed 6 March 2020

  16. Cockcroft DW, Gault MH (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16(1):31–41. https://doi.org/10.1159/000180580

    Article  CAS  Google Scholar 

  17. Ohno J, Sotomi Y, Hirata A, Sakata Y, Hirayama A, Higuchi Y (2021) Dose of direct oral anticoagulants and adverse outcomes in Asia. Am J Cardiol 139:50–56. https://doi.org/10.1016/j.amjcard.2020.09.053

    Article  CAS  PubMed  Google Scholar 

  18. Lip GYH, Banerjee A, Boriani G, Chiang CE, Fargo R, Freedman B, Lane DA, Ruff CT, Turakhia M, Werring D, Patel S, Moores L (2018) Antithrombotic therapy for atrial fibrillation: CHEST guideline and expert panel report. Chest 154(5):1121–1201. https://doi.org/10.1016/j.chest.2018.07.040

    Article  PubMed  Google Scholar 

  19. Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL, Group ESCSD (2021) 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J 42(5):373–498. https://doi.org/10.1093/eurheartj/ehaa612

    Article  Google Scholar 

  20. Huang CX, Zhang S, Huang JD, Hua W (2018) Current knowledge and management recommendations of atrial fibrillation. Chinese Journal of Cardiac Arrhythmias 22(04):279–346

  21. Chao TF, Lip GY, Liu CJ, Tuan TC, Chen SJ, Wang KL, Lin YJ, Chang SL, Lo LW, Hu YF, Chen TJ, Chiang CE, Chen SA (2016) Validation of a modified CHA2DS2-VASc score for stroke risk stratification in Asian patients with atrial fibrillation: a nationwide cohort study. Stroke 47(10):2462–2469. https://doi.org/10.1161/STROKEAHA.116.013880

    Article  CAS  PubMed  Google Scholar 

  22. Hart RG, Pearce LA, Aguilar MI (2007) Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 146(12):857–867. https://doi.org/10.7326/0003-4819-146-12-200706190-00007

    Article  PubMed  Google Scholar 

  23. Wang KL, Lip GY, Lin SJ, Chiang CE (2015) Non-vitamin K antagonist oral anticoagulants for stroke prevention in Asian patients with nonvalvular atrial fibrillation: meta-analysis. Stroke 46(9):2555–2561. https://doi.org/10.1161/STROKEAHA.115.009947

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. Chan YH, Yeh YH, Tu HT, Kuo CT, Chang SH, Wu LS, Lee HF, See LC (2017) Bleeding risk with dabigatran, rivaroxaban, warfarin, and antiplatelet agent in Asians with non-valvular atrial fibrillation. Oncotarget 8(58):98898–98917. https://doi.org/10.18632/oncotarget.22026

    Article  PubMed  PubMed Central  Google Scholar 

  25. Andersen LV, Vestergaard P, Deichgraeber P, Lindholt JS, Mortensen LS, Frost L (2008) Warfarin for the prevention of systemic embolism in patients with non-valvular atrial fibrillation: a meta-analysis. Heart 94(12):1607–1613. https://doi.org/10.1136/hrt.2007.135657

    Article  CAS  PubMed  Google Scholar 

  26. Gu ZC, Kong LC, Yang SF, Wei AH, Wang N, Ding Z, Zhang C, Liu XY, Zheng YL, Lin HW (2019) Net clinical benefit of non-vitamin K antagonist oral anticoagulants in atrial fibrillation and chronic kidney disease: a trade-off analysis from four phase III clinical trials. Cardiovasc Diagn Ther 9(5):410–419. https://doi.org/10.21037/cdt.2019.07.09

    Article  PubMed  PubMed Central  Google Scholar 

  27. Shewale AR, Johnson JT, Li C, Nelsen D, Martin BC (2015) Net clinical benefits of guidelines and decision tool recommendations for oral anticoagulant use among patients with atrial fibrillation. J Stroke Cerebrovasc Dis 24(12):2845–2853. https://doi.org/10.1016/j.jstrokecerebrovasdis.2015.08.019

    Article  PubMed  PubMed Central  Google Scholar 

  28. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM, Investigators RA (2011) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365(10):883–891. https://doi.org/10.1056/NEJMoa1009638

    Article  CAS  PubMed  Google Scholar 

  29. Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM, Investigators EA-T (2013) Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 369(22):2093–2104. https://doi.org/10.1056/NEJMoa1310907

    Article  CAS  PubMed  Google Scholar 

  30. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L, Committee R-LS, Investigators (2009) Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361(12):1139–1151. https://doi.org/10.1056/NEJMoa0905561

    Article  CAS  PubMed  Google Scholar 

  31. Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W, Subcommittee on Control of Anticoagulation of the S, Standardization Committee of the International Society on T, Haemostasis (2010) Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost 8(1):202–204. https://doi.org/10.1111/j.1538-7836.2009.03678.x

    Article  Google Scholar 

  32. Zhang S, Yang YM, Huang CX, Huang JD, Cao KJ, Zhu J, Peng B, Yang JF, Xu W, Wang JF, Wang ZL, Wu LQ, Zhao XX, Tang BP (2018) Guideline of stroke prevention in Chinese patients with atrial fibrillation. Chinese Journal of Cardiac Arrhythmias 22(01):17–30. https://doi.org/10.3760/cma.j.issn.1007-6638.2018.01.006

    Article  Google Scholar 

  33. Steffel J, Collins R, Antz M, Cornu P, Desteghe L, Haeusler KG, Oldgren J, Reinecke H, Roldan-Schilling V, Rowell N, Sinnaeve P, Vanassche T, Potpara T, Camm AJ, Heidbuchel H, External R, Lip GYH, Deneke T, Dagres N, Boriani G, Chao TF, Choi EK, Hills MT, Santos IS, Lane DA, Atar D, Joung B, Cole OM, Field M (2021) 2021 European Heart Rhythm Association practical guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Europace. https://doi.org/10.1093/europace/euab065

    Article  PubMed  Google Scholar 

  34. Santos J, Antonio N, Rocha M, Fortuna A (2020) Impact of direct oral anticoagulant off-label doses on clinical outcomes of atrial fibrillation patients: a systematic review. Br J Clin Pharmacol 86(3):533–547. https://doi.org/10.1111/bcp.14127

    Article  PubMed  PubMed Central  Google Scholar 

  35. Steinberg BA, Shrader P, Thomas L, Ansell J, Fonarow GC, Gersh BJ, Kowey PR, Mahaffey KW, Naccarelli G, Reiffel J, Singer DE, Peterson ED, Piccini JP, Investigators O-A, Patients (2016) Off-label dosing of non-vitamin K antagonist oral anticoagulants and adverse outcomes: the ORBIT-AF II Registry. J Am Coll Cardiol 68(24):2597–2604. https://doi.org/10.1016/j.jacc.2016.09.966

    Article  CAS  PubMed  Google Scholar 

  36. Chiang CE, Wang KL, Lip GY (2014) Stroke prevention in atrial fibrillation: an Asian perspective. Thromb Haemost 111(5):789–797. https://doi.org/10.1160/TH13-11-0948

    Article  CAS  PubMed  Google Scholar 

  37. Ruff CT (2020) The promise of mobile health in managing atrial fibrillation. J Am Coll Cardiol 75(13):1535–1537. https://doi.org/10.1016/j.jacc.2020.02.039

    Article  PubMed  Google Scholar 

  38. Guo Y, Lane DA, Wang L, Chen Y, Lip GYH, m AFAIITi (2019) Mobile Health (mHealth) technology for improved screening, patient involvement and optimising integrated care in atrial fibrillation: The mAFA (mAF-App) II randomised trial. Int J Clin Pract 73(7)https://doi.org/10.1111/ijcp.13352

  39. Zeballos-Palacios CL, Hargraves IG, Noseworthy PA, Branda ME, Kunneman M, Burnett B, Gionfriddo MR, McLeod CJ, Gorr H, Brito JP, Montori VM, Making SD, Shared Decision Making for Atrial Fibrillation Trial I (2019) Developing a conversation aid to support shared decision making: reflections on designing anticoagulation choice. Mayo Clin Proc 94(4):686–696. https://doi.org/10.1016/j.mayocp.2018.08.030

    Article  PubMed  Google Scholar 

  40. Peeples MM, Iyer AK, Cohen JL (2013) Integration of a mobile-integrated therapy with electronic health records: lessons learned. J Diabetes Sci Technol 7(3):602–611. https://doi.org/10.1177/193229681300700304

    Article  PubMed  PubMed Central  Google Scholar 

  41. Ventola CL (2014) Mobile devices and apps for health care professionals: uses and benefits. P T 39(5):356–364

    PubMed  PubMed Central  Google Scholar 

  42. Chow CK, Ariyarathna N, Islam SM, Thiagalingam A, Redfern J (2016) mHealth in Cardiovascular Health Care. Heart Lung Circ 25(8):802–807. https://doi.org/10.1016/j.hlc.2016.04.009

    Article  PubMed  Google Scholar 

Download references

Funding

This work was supported by the Ren Ji Boost Project of National Natural Science Foundation of China (RJTJ-JX-001), Research Funds of Shanghai Health and Family Planning commission (20184Y0022), WU JIEPING medical foundation (320.6750.2020–04-30), Clinical Pharmacy Innovation Research Institute of Shanghai Jiao Tong University School of Medicine (CXYJY2019ZD001), and Shanghai “Rising Stars of Medical Talent” Youth Development Program – Youth Medical Talents – Clinical Pharmacist Program (SHWJRS (2019) 072; SHWRS (2020) 087).

Author information

Author notes

  1. Chi Zhang and Mang-Mang Pan contributed equally to this work, and should be considered co-first authors

Authors and Affiliations

  1. Department of Pharmacy, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China

    Chi Zhang, Mang-Mang Pan, Zhi-Chun Gu & Hou-Wen Lin

  2. School of Medicine, Tongji University, Shanghai, 200092, China

    Chi Zhang & Hou-Wen Lin

  3. Shanghai Pharmaceutical Association, Shanghai Anticoagulation Pharmacist Alliance, Shanghai, 200040, China

    Chi Zhang, Zhi-Chun Gu & Hou-Wen Lin

  4. Department of Pharmacy, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, 400010, China

    Na Wang

  5. Department of S/4HANA Research & Development, SAP (China) Co., Ltd, Shanghai, 201203, China

    Wei-Wei Wang

  6. Department of Cardiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200127, China

    Zheng Li

Authors
  1. Chi Zhang
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Mang-Mang Pan
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Na Wang
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Wei-Wei Wang
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Zheng Li
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Zhi-Chun Gu
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Hou-Wen Lin
    View author publications

    You can also search for this author in PubMed Google Scholar

Contributions

Z.G. and C.Z. conceived of the presented idea and designed structure of the I-Anticoagulant. N.W. collected the recommendations on anticoagulation therapy in current guidelines. W.W. and C.Z. developed the WeChat Mini Program of I-Anticoagulant. M.P. and Z.L. contributed to the implementation of the pilot study. H.L. and Z.G. supervised the finding of this study. C.Z. and M.P. wrote the manuscript. Z.G. and H.L. revised the manuscript.

Corresponding author

Correspondence to Zhi-Chun Gu.

Ethics declarations

Ethics approval and consent to participate

The study was approved by the ethics committee of Ren Ji hospital (#2018–025) and informed consent was obtained from each patient or their family members. We conducted this study according to the Declaration of Helsinki, ethical principles of medical research involving human subjects (revision Fortaleza, Brazil, October 2013).

Conflict of interest

The authors declare no competing interests.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Supplementary information

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 2281 KB)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Zhang, C., Pan, MM., Wang, N. et al. Feasibility and usability of a mobile health tool on anticoagulation management for patients with atrial fibrillation: a pilot study. Eur J Clin Pharmacol 78, 293–304 (2022). https://doi.org/10.1007/s00228-021-03236-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-021-03236-4

Keywords

Search

Navigation