Self-management program improves anticoagulation control and quality of life: a prospective randomized study

Abstract

Objective: Previous retrospective studies suggest that patients' self management of oral anticoagulants leads to improved control. In this prospective randomized study, we investigated the effects of self management on the control of anticoagulant therapy and quality of life. Comparison with the conventional management through the Dutch Thrombosis Service is addressed.

Methods: Between January 2005 and June 2007, 62 consecutive patients who underwent elective mechanical aortic valve replacement were included in this study. Patients were randomized into two groups: (1) conventional group controlled by the Local Thrombosis Service, and (2) self management group using CoaguChek. Primary endpoints were the total number of international normalized ratio (INR) values within the target range as well as the quality of life measurements (SF-36v2) one year postoperatively.

Results: The number of INR values within the target range (2.5-4.5) was significantly higher in the self management group (mean=72.9+/-11%) than in the conventional group (53.9+/-14%; p=0.01). Both groups showed an improvement in the quality of life scores one year postoperatively. However, postoperative improvement was statistically significant in the self management group regarding the physical component summary only (p=0.001).

Conclusion: Despite the well-organized INR control by the Thrombosis Service in The Netherlands, self management program after adequate training improves the INR control. Postoperative improvement in the quality of life scores was significant in the self management group with regards to the physical component summary only. Further studies are needed to describe whether self management program will reduce the risk of bleeding and/or thrombo-embolism.