TY - JOUR

T1 - Self-management versus conventional management of oral anticoagulant therapy

T2 - A randomized, controlled trial

AU - Christensen, Thomas D

AU - Maegaard, Marianne

AU - Sørensen, Henrik T

AU - Hjortdal, Vibeke E

AU - Hasenkam, J Michael

PY - 2006/7

Y1 - 2006/7

N2 - BACKGROUND: The efficacy of self-managed oral anticoagulant therapy has been addressed in few randomized, controlled trials, which have provided inconsistent results. The aim of this study was to compare the quality of self-managed oral anticoagulant therapy with conventional management.METHODS: This was a pragmatic, open-label, randomized, controlled trial where 100 patients receiving long-term oral anticoagulant therapy referred to a Danish clinic for self-management was randomized to either self-management of oral anticoagulant therapy (including a teaching program of self-management followed by 6 months of self-management) or 6 months of conventional management. The primary endpoint was an intention-to-treat analysis of a composite score combining the variance (median square of the standard deviation) of the International Normalized Ratio (INR) value (using a blinded control sample analyzed monthly by a reference laboratory), death, major complications, or discontinuation from the study. Secondary endpoints - assessed in per-protocol analyses - were the variance of the INR value (using the blinded control sample) and time within therapeutic INR target range using the standard INR values from the coagulometer and laboratory measurement.RESULTS: There was no significant difference in the primary endpoint between the self-management and conventional management groups (composite score 0.16 vs. 0.24, respectively, p=0.09). Self-management was significantly better (0.16 vs. 0.24, p=0.003) with regard to the variance in a per-protocol analysis. The difference in time within therapeutic INR target range was not significantly better (78.7% vs. 68.9%, p=0.14) using self-management.CONCLUSION: The quality of self-management of oral anticoagulant therapy is at least as good as that provided by conventional management.

AB - BACKGROUND: The efficacy of self-managed oral anticoagulant therapy has been addressed in few randomized, controlled trials, which have provided inconsistent results. The aim of this study was to compare the quality of self-managed oral anticoagulant therapy with conventional management.METHODS: This was a pragmatic, open-label, randomized, controlled trial where 100 patients receiving long-term oral anticoagulant therapy referred to a Danish clinic for self-management was randomized to either self-management of oral anticoagulant therapy (including a teaching program of self-management followed by 6 months of self-management) or 6 months of conventional management. The primary endpoint was an intention-to-treat analysis of a composite score combining the variance (median square of the standard deviation) of the International Normalized Ratio (INR) value (using a blinded control sample analyzed monthly by a reference laboratory), death, major complications, or discontinuation from the study. Secondary endpoints - assessed in per-protocol analyses - were the variance of the INR value (using the blinded control sample) and time within therapeutic INR target range using the standard INR values from the coagulometer and laboratory measurement.RESULTS: There was no significant difference in the primary endpoint between the self-management and conventional management groups (composite score 0.16 vs. 0.24, respectively, p=0.09). Self-management was significantly better (0.16 vs. 0.24, p=0.003) with regard to the variance in a per-protocol analysis. The difference in time within therapeutic INR target range was not significantly better (78.7% vs. 68.9%, p=0.14) using self-management.CONCLUSION: The quality of self-management of oral anticoagulant therapy is at least as good as that provided by conventional management.

U2 - 10.1016/j.ejim.2005.11.021

DO - 10.1016/j.ejim.2005.11.021

M3 - Journal article

C2 - 16762775

VL - 17

SP - 260

EP - 266

JO - European Journal of Internal Medicine

JF - European Journal of Internal Medicine

SN - 0953-6205

IS - 4

ER -