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A Randomized Controlled Trial

Peter T. Sawicki, MD, PhD; for the Working Group for the Study of Patient Self-Management of Oral Anticoagulation

JAMA. 1999;281:145-150.

Context  Control of oral anticoagulation therapy has been reported to often be inadequate. Previous retrospective investigations suggest that patients' self-adjustment of oral anticoagulants may lead to improved control.

Objective  To investigate the effects of patients' self-management of oral anticoagulation therapy on accuracy of control and measures of treatment-related quality of life.

Design  Randomized, single-blind, multicenter trial.

Setting and Participants  A total of 179 patients receiving long-term oral anticoagulation treatment were enrolled at 5 referral centers in Germany.

Intervention  Patients were randomized to an oral anticoagulation self-management group based on a structured treatment and teaching program and international normalized ratio (INR) self-monitoring. The control group received conventional care as provided by family physicians, including referral to specialists if necessary.

Main Outcome Measures  Deviation of INR values from the individual INR target range (squared) and the 5 categories of treatment-related quality of life.

Results  Deviation of INR value from the mean of the INR target range was significantly lower in the intervention group at 3-month (squared INR deviation, 0.59 vs 0.95; P<.001) and 6-month follow-up (0.65 vs 0.83; P=.03) compared with the control group. Also, the intervention group had INR values within the target range more often (repeated measurement analysis for categorical data, P=.006). The results were mainly due to less frequent suboptimal INR values in the intervention group (32.8% vs 50.0% [P=.03] at 3-month, and 33.7% vs 48.2% [P=.08] at 6-month follow-up). Treatment-related quality-of-life measures, especially treatment satisfaction scores, were significantly higher in the intervention group compared with controls.

Conclusions  An anticoagulation education program that includes self-management of anticoagulation therapy results in improved accuracy of anticoagulation control and in treatment-related quality-of-life measures. Further studies are needed to describe whether the program will reduce risk of bleeding or thromboembolism.

Author Affiliations: Working Group for the Study of Patient Self-Management of Oral Anticoagulation: Heinrich-Heine University, Department of Metabolic Diseases and Nutrition (Co-Coordinating Center): Ulrike Didjurgeit, Jutta Fischer, Rose Steinhoff, Ralf Bender, PhD, Rainer Götzinger, MD, Thorsten Johannsen, Andreas Richter, Peter T. Sawicki, MD, PhD; Department of Haemostasis and Transfusion Medicine: Ruediger E. Scharf, MD, PhD; Department of Thorax and Cardiosurgery: Hans M. Klein, MD, PhD, Düsseldorf, Germany; Herz-Kreislauf-Klinik: Angelika Bernardo, MD, Carola Halhuber, MD, Artur Bernardo, MD, Bad Berleburg, Germany; Kerckhoff-Klinik: Katrin Heidinger, MD, Uwe Taborski, MD, Bad Nauheim, Germany; Fachklinik Rhein-Ruhr: Marianne Hinz, MD, Lothar Benesch, MD, Essen, Germany; and Herz-Zentrum: Christa Gohlke-Bärwolf, MD, Alvaro Jadue-Lozier, Karl-Heinz Wilhelm, Bad Krozingen, Germany.

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