Evaluation of an anticoagulation management method based on mobile health technology and artificial intelligence / 中华健康管理学杂志

ABSTRACT

Objective:To evaluate an anticoagulation management method based on mobile health technology and artificial intelligence.Methods:The study was a single-center, prospective, randomized, controlled, non-inferiority clinical trial. From November 2017 to September 2018, 67 patients who received warfarin therapy after mechanical valve replacement were consecutively enrolled and randomized into two groups 34 were randomized to intervention group and 33 to control group. The intervention group was managed via Anticlot Assistant and the control group was handled as routine care. Evaluations were performed at least 3 months after enrollment and ended on 30 September 2019. Non-inferiority was evaluated using one-sided tests with a non-inferiority margin set 11.0% for time in therapeutic range (TTR) and 10.0% for the percentage of international normalized ratio (INR) in the therapeutic range.Results:The mean TTR was (58.2±23.4)% in the intervention group and (54.8±23.6)% in the control (the difference 3.4%; low limit of one-side 95% confidence interval for the difference -6.4%; and P value for non-inferiority was 0.009). The percentage of INR in the therapeutic range was (55.4±21.9)% in the intervention group and (52.8±22.5)% in the control (the difference 2.6%, low limit of one-side 95% confidence interval for the difference -6.6%; and P value for non-inferiority was 0.012). Conclusion:The outcomes of patients managed via the anticoagulation management method base on mobile health technology and artificial intelligence are not inferior to those handled as routine care.