Clinical trial NCT00978445: Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System
Official title: Use of a Novel Remote Home PT/INR-monitoring Device for Long-Term Anticoagulation Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Keywords: Systemic embolic events
Thromboembolic Complications with Atrial Fibrillation
Prophylaxis with Atrial Fibrillation
Mechanical Cardiac Valve Replacement
Lead sponsor: ZIN Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
First posted: 2009-09-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The creation of optimal devices for patient self-testing protocols for anticoagulation management is an area of active medical research. The current pilot study represents the initial step in the development of a new customized device for this purpose, the vMetrics - Anticoagulation Monitoring System. The v-Metrics Anticoagulation Monitoring System (vMetrics AMS) is defined by: 1. A PT/INR home monitoring unit which interfaces to FDA approved PT/INR home monitors such as the Hemosense INRatio device, and 2. an anticoagulation clinic patient management application which manages patient communications, database of prior test results, testing schedules, and communication to an EMR.

The INR home-monitoring system to be tested in this study will address several of the limitations of currently available technologies and practices for standard and home INR self-testing. The proposed project will develop a self-testing device that maximizes safety and efficiency for both the patient and the health care provider. The monitoring device (vMetrics) allows the wireless transmission of the INR result from an approved home INR measuring monitoring device (ex:HemoSense - INRatio) to a secure database in a health care provider staffed anticoagulation clinic. The device will also collect yes/no responses to a set of standard questions from the subject to assure patient safety and determine optimal Coumadin dosing. Upon receipt of the patient data, the Coumadin provider can review the INR result and responses to the questions and use standard Coumadin dosing protocols and clinical judgment to transmit dosing instructions back to the patient through the device. A calendar schedule of dosing until the next scheduled INR check will be transmitted to the patient. In certain instances (i.e., high INR \> 5), the device will transmit instructions to call the Coumadin clinic. The subject will confirm receipt of the Coumadin dose sent to him/her by pressing a button on the device (which transmits the confirmation back to the database). This process may reduce inconvenience to the subject, the INR value is reported directly from the device reducing the possibility of error, two-way communication is wireless and will reduce the need for telephone contact, thus potentially saving health care provider and patient time. In addition, the data from the encounter will be available in a form that can be entered into the patient's electronic medical record. The patient will enter data into the device using a 4-digit passcode that will allow for security of data.

In addition to coordinating INR transmission through the home INR device, a customized database will provide a platform for the anticoagulation clinic patient management application (Wireless Home Coumadin clinic). This platform which will organize the workflow of the Coumadin provider to more easily determine which patients are due (or overdue) for monitoring, and which patients have transmitted an INR value and questionnaire and are awaiting a response.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time Spent Per PT/INR Monitoring Encounter
timeFrame: Once per week during 12 week study
Secondary outcomes:
measure: Change in Quality of Life - Based on Quality of Life Scores PSQ-18 (Short Form Patient Satisfaction Questionnaire) Duke Anticoagulation Satisfaction Scale SF-12 (Short Form 12 Version 2) Quality of Life Questionnaire
timeFrame: During study vist number 2 after 12 week study period, repeated after second study 12 week period study visit #3
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic main campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Heather Gornik, M.D.
role: PRINCIPAL_INVESTIGATOR
References: