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Sponsors and Collaborators: |
University College Cork Hoffmann-La Roche Irish Health Research Board ZyCare Inc |
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Information provided by: | University College Cork |
ClinicalTrials.gov Identifier: | NCT00594828 |
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.
Condition | Intervention | Phase |
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Warfarin |
Device: CoaguChek (Patient self testing) Device: Anticoagulation Management Service (AMS) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Randomized Controlled Trial of Patient Self-Testing of Warfarin Therapy Using an Internet Based Expert System |
Enrollment: | 163 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | April 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
6 months of supervised patient self testing using an expert system
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Device: CoaguChek (Patient self testing)
Patients will test their INR at home either biweekly, weekly or every 2 weeks using a CoaguChek point of care meter and communicate with the healthcare provider via an internet based expert system
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2: Active Comparator
6 months of routine medical care by the anticoagulation management service
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Device: Anticoagulation Management Service (AMS)
Patients will attend the AMS for six months and have their INR checked every 4-6 weeks or more frequently, at the discretion of the clinician
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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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Ireland | |
Cork University Hospital | |
Cork, Ireland |
Principal Investigator: | Susan J O'Shea, MD | Cork University Hospital |
Responsible Party: | University College Cork ( Dr Susan O'Shea ) |
Study ID Numbers: | PA/05/16 |
Study First Received: | January 7, 2008 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00594828 |
Health Authority: | Ireland: Irish Medicines Board; Ireland: Medical Ethics Research Committee |
Patient self-testing Oral anticoagulation therapy Expert Systems Point-of-Care Systems International Normalized Ratio |
Warfarin |