Patient Self Testing of Warfarin Therapy

University College Cork (UCC)

Status and phase

Unknown

Phase 4

Conditions

Warfarin

Treatments

Device: Anticoagulation Management Service (AMS)

Device: CoaguChek (Patient self testing)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00594828

PA/05/16

Details and patient eligibility

About

To test the hypothesis that home international normalised ratio (INR) monitoring with supervised patient self-testing (PST)can provide comparable or superior time in therapeutic range (TTR) to that provided by traditional outpatient anticoagulation.

Full description

Indications for anticoagulant treatment to prevent thromboembolic disease have increased in recent years. INR must be monitored frequently to determine the safest dose and to minimize the risk for thrombotic and haemorrhagic complications. Standard warfarin therapy is associated with rates of major haemorrhage of up to 5-9% annually and recurrent venous thromboembolism of up to 8%. These event rates are dependent of the model of care used to manage warfarin therapy, with better outcomes associated with home testing of the INR which enables patients to monitor their response to warfarin more frequently. INR results must still be 'managed' by communicating the data to the healthcare provider, usually be telephone or fax.

In this study we will evaluate a novel method of PST; supervised PST with an internet based expert system, which 'manages' patients on oral anticoagulation by utilizing clinical and laboratory data provided by the patient and dose adjustment and retesting algorithms derived from clinical practice. Patients will be randomized to either 6 months of supervised PST or routine medical care by the AMS. At the end of the 6 month period, each patient will then 'cross over' to the other management regimen and the difference in TTR between the two periods will be compared.

Enrollment

163 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

on warfarin therapy for a minimum of 2 months
are expected to be on warfarin therapy for the duration of the 12 month study
internet access

Exclusion criteria

inability to provide informed consent
inability to use a home INR meter
patients who do not have a telephone
more than 2 missed clinic appointments in the preceding 6 months
patients on anticoagulant drugs other than warfarin (eg heparin, low molecular weight heparin)
history of hemorrhagic complications with a therapeutic or therapeutic INR in the preceding 6 months
inability to attend the hospital at short notice, if necessary