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Study Protocol

Monitoring and Follow-Up of Patients on Vitamin K Antagonist Oral Anticoagulant Therapy Using Artificial Intelligence: The AIto-Control Project

by
Adolfo Romero-Arana
1,
Nerea Romero-Sibajas
2,
Elena Arroyo-Bello
1,
Adolfo Romero-Ruiz
3,4,5,* and
Juan Gómez-Salgado
6,7
1
Fundación Jiménez Díaz School of Nursing, Health Research Institute, Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid (IIS-FJD, UAM), 28040 Madrid, Spain
2
La Paz University Hospital, Madrid Health Service, 28046 Madrid, Spain
3
BA-16 Group, Institute of Biomedical Research of Malaga and Platform in Nanomedicine-IBIMA Platform BIONAND, 29590 Málaga, Spain
4
Research Unit, Hospital Virgen de la Victoria, Andalusian Health Service, 29010 Málaga, Spain
5
Department of Nursing and Podiatry, Health Sciences School, University of Málaga, 29071 Málaga, Spain
6
Department of Sociology, Social Work and Public Health, Faculty of Labour Sciences, University of Huelva, 21007 Huelva, Spain
7
Safety and Health Postgraduate Programme, Universidad Espíritu Santo, Guayaquil 092301, Ecuador
*
Author to whom correspondence should be addressed.
J. Clin. Med. 2025, 14(20), 7191; https://doi.org/10.3390/jcm14207191 (registering DOI)
Submission received: 12 September 2025 / Revised: 11 October 2025 / Accepted: 11 October 2025 / Published: 12 October 2025
(This article belongs to the Special Issue Thrombosis and Haemostasis: Clinical Advances)

Abstract

Background: Vitamin K antagonist oral anticoagulant (VKA) therapy, using warfarin or acenocoumarol in our health system, is indicated, according to clinical guidelines, for the prophylaxis of thromboembolic events. In Málaga, the VKA patient management program currently includes a total of 856 patients. Hypothesis: The use of an AI-based application can enhance treatment adherence among VKA patients participating in self-monitoring and self-management programs. Furthermore, it can support the comprehensive implementation of the system, leading to reduced costs and fewer interventions for anticoagulated patients. Methods: The study will be conducted in several phases. The first phase involves the development of the application and the integration of Artificial Intelligence (AI) and Machine Learning (ML) algorithms. The second phase includes preliminary testing and validation of the developed application. The third phase consists of full implementation, along with an assessment of user-identified needs and potential quality improvements. Expected Results: The implementation of the AIto-Control app is expected to reduce healthcare-related costs by decreasing primary care visits and hospital admissions due to thromboembolic or bleeding events. Additionally, it aims to ease the workload on both primary care and hospital services. These outcomes will be achieved through the involvement of advanced practice nurses who will supervise app-based monitoring and patient education.
Keywords: anticoagulation management program; vitamin k antagonist; app development; AI assistants anticoagulation management program; vitamin k antagonist; app development; AI assistants

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MDPI and ACS Style

Romero-Arana, A.; Romero-Sibajas, N.; Arroyo-Bello, E.; Romero-Ruiz, A.; Gómez-Salgado, J. Monitoring and Follow-Up of Patients on Vitamin K Antagonist Oral Anticoagulant Therapy Using Artificial Intelligence: The AIto-Control Project. J. Clin. Med. 2025, 14, 7191. https://doi.org/10.3390/jcm14207191

AMA Style

Romero-Arana A, Romero-Sibajas N, Arroyo-Bello E, Romero-Ruiz A, Gómez-Salgado J. Monitoring and Follow-Up of Patients on Vitamin K Antagonist Oral Anticoagulant Therapy Using Artificial Intelligence: The AIto-Control Project. Journal of Clinical Medicine. 2025; 14(20):7191. https://doi.org/10.3390/jcm14207191

Chicago/Turabian Style

Romero-Arana, Adolfo, Nerea Romero-Sibajas, Elena Arroyo-Bello, Adolfo Romero-Ruiz, and Juan Gómez-Salgado. 2025. "Monitoring and Follow-Up of Patients on Vitamin K Antagonist Oral Anticoagulant Therapy Using Artificial Intelligence: The AIto-Control Project" Journal of Clinical Medicine 14, no. 20: 7191. https://doi.org/10.3390/jcm14207191

APA Style

Romero-Arana, A., Romero-Sibajas, N., Arroyo-Bello, E., Romero-Ruiz, A., & Gómez-Salgado, J. (2025). Monitoring and Follow-Up of Patients on Vitamin K Antagonist Oral Anticoagulant Therapy Using Artificial Intelligence: The AIto-Control Project. Journal of Clinical Medicine, 14(20), 7191. https://doi.org/10.3390/jcm14207191

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