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JAMA. 1999 Jan 13;281(2):145-50.

A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled trial. Working Group for the Study of Patient Self-Management of Oral Anticoagulation.

Author information

1
Heinrich-Heine University, Department of Metabolic Diseases and Nutrition (Co-Coordinating Center), Düsseldorf, Germany. Sawicki@med.uni-duesseldorf.de

Abstract

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.

PMID:
9917117
DOI:
10.1001/jama.281.2.145
[Indexed for MEDLINE]

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