Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System

Completed · Not applicable

Conditions studied: Venous Thromboembolism

In brief

Long-term anticoagulation is indicated in patients for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or mechanical cardiac valve replacement, prevention or treatment of venous thromboembolism (deep vein thrombosis and pulmonary embolism), to prevent thromboembolic events post-myocardial infarction, and in patients with systemic embolic events. Currently the only approved oral medication for anticoagulation is warfarin (Coumadin, Bristol-Myers Squibb and generic warfarin. Dosage is controlled by periodic determinations of the prothrombin time (PT)/International Normalized Ratio (INR). Under treatment may lead to venous or arterial thrombotic events or stroke, while over treatment may lead to major bleeding and even death. Patients require frequent INR monitoring to maintain a therapeutic level of anticoagulation. The therapeutic INR range varies by clinical indication, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The vMetrics - Anticoagulation Management System is a remote patient management solution for Oral Anticoagulation Care patients. This system provides confirmation of patient question and testing protocols as well as virtual patient management care capability for dosage and patient scheduling. This trial will provide end points to ascertain efficiency against standard care protocol and confirm equivalent care standards.

Key facts

Study ID

NCT00978445

Run by

ZIN Technologies, Inc.

People needed

25

Starts

2009-09-01

Expected to finish

2010-08-01

Last updated by the study team

2013-03-21

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ages 18-80 years
• Requires long-term oral anticoagulation therapy for one of the following indications:
• Venous thromboembolism (deep vein thrombosis or pulmonary embolism)
• Arterial thromboembolic event(s)
• Atrial fibrillation
• Mechanical heart valve
• INR goal set at 2-3 by supervising physician
• Subject has been followed in the Vascular Medicine Coumadin program for at least 3 months
• No INR values > 7, and no major thrombotic or bleeding complications within the preceding 3 months of follow-up in the Coumadin program.
• Subject has been compliant with INR monitoring during period of enrollment in the Vascular Medicine Coumadin program.
• Physically able and willing to perform finger stick INR measurements on self
• Able to use the hand-held monitoring device and have adequate vision to read information on the device screen

You may not qualify if…

• Inability to speak and read English
• Anticipated interruption in anticoagulation within the next 6 months (e.g., for elective major surgery, pregnancy)
• Cognitive impairment which makes ability to perform necessary procedures related to the remote home monitoring device unlikely

Where it is running

• Cleveland Clinic main campus — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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