Patient Self Testing of Warfarin Therapy
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|ClinicalTrials.gov Identifier: NCT00594828|
Recruitment Status : Unknown
Verified January 2008 by University College Cork.
Recruitment status was: Active, not recruiting
First Posted : January 16, 2008
Last Update Posted : January 16, 2008
|Condition or disease||Intervention/treatment||Phase|
|Warfarin||Device: CoaguChek (Patient self testing) Device: Anticoagulation Management Service (AMS)||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||163 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of Patient Self-Testing of Warfarin Therapy Using an Internet Based Expert System|
|Study Start Date :||July 2006|
|Estimated Primary Completion Date :||April 2009|
|Estimated Study Completion Date :||April 2008|
6 months of supervised patient self testing using an expert system
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
Active Comparator: 2
6 months of routine medical care by the anticoagulation management service
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
- The primary outcome variable used to assess therapeutic efficacy and safety will be the difference in TTR during the six months of AMS management and the six months of PST [ Time Frame: 1 year ]
- To compare the number of adverse events (haemorrhagic and thromboembolic) using PST and AMS management [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594828
|Cork University Hospital|
|Principal Investigator:||Susan J O'Shea, MD||Cork University Hospital|