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

NCT00978445 | Completed Results DMC

• 1 other identifier: vMetrics-AMS-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism

Keywords

Systemic embolic events; Thromboembolic Complications with Atrial Fibrillation; Prophylaxis with Atrial Fibrillation; Mechanical Cardiac Valve Replacement

Outcome Measures

Primary Outcomes (1)

• Time Spent Per PT/INR Monitoring Encounter

  minutes spent measuring coagulation time of blood on standard versus home protocol

  Once per week during 12 week study

Secondary Outcomes (1)

• 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

  During study vist number 2 after 12 week study period, repeated after second study 12 week period study visit #3

Study Arms (2)

Home/Standard

EXPERIMENTAL

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

Standard/Home

EXPERIMENTAL

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

Interventions

vMetrics protocol OTHER

use vmetrics protocol and device or use standard in clinic monitoring

Home/Standard; Standard/Home

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• ZIN Technologies, Inc.: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

Cleveland Clinic main campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Heather Gornik
• Organization: Cleveland Clinic Foundation

gornikh@ccf.org

216-445-3689

Study Officials

• Heather Gornik, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Technology

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 17, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 21, 2013
• Results First Posted: March 21, 2013

Record last verified: 2013-03

Locations

US (1)