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

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Carlos Grodsinsky, ZIN Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00978445
First received: September 15, 2009
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Venous Thromboembolism
Other: vMetrics protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of a Novel Remote Home PT/INR-monitoring Device for Long-Term Anticoagulation Management

Resource links provided by NLM:


Further study details as provided by ZIN Technologies, Inc.:

Primary Outcome Measures:
  • Time Spent Per PT/INR Monitoring Encounter [ Time Frame: Once per week during 12 week study ] [ Designated as safety issue: No ]
    minutes spent measuring coagulation time of blood on standard versus home protocol


Secondary Outcome Measures:
  • 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 [ Time Frame: During study vist number 2 after 12 week study period, repeated after second study 12 week period study visit #3 ] [ Designated as safety issue: No ]

    we are interested in the relative measure of quality of life by comparing quality of life measures through use of PSQ-18 and other measures listed.

    Higher scores indicate a better quality of life.



Enrollment: 25
Study Start Date: September 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home/Standard
all participants recieved vMetric protocol at home and in clinical setting, in this ARM the standard protocol was at home first then in clinic INR and interaction with a care giver.
Other: vMetrics protocol
use vmetrics protocol and device or use standard in clinic monitoring
Experimental: Standard/Home
all participants recieved vMetric protocol at home and in clinical setting, in this ARM the standard protocol was an in clinic INR and interaction with a care giver, then the Home protocol was as described.
Other: vMetrics protocol
use vmetrics protocol and device or use standard in clinic monitoring

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978445

Locations
United States, Ohio
Cleveland Clinic main campus
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
ZIN Technologies, Inc.
The Cleveland Clinic
Investigators
Principal Investigator: Heather Gornik, M.D. The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Carlos Grodsinsky, Vice President of Technology, ZIN Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00978445     History of Changes
Other Study ID Numbers: vMetrics-AMS-01
Study First Received: September 15, 2009
Results First Received: July 18, 2012
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by ZIN Technologies, Inc.:
Systemic embolic events
Thromboembolic Complications with Atrial Fibrillation
Prophylaxis with Atrial Fibrillation
Mechanical Cardiac Valve Replacement

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on August 20, 2014