- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00978445
Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System (vMetrics-AMS)
Use of a Novel Remote Home PT/INR-monitoring Device for Long-Term Anticoagulation Management
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic Main Campus
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
use vmetrics protocol and device or use standard in clinic monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Spent Per PT/INR Monitoring Encounter
Time Frame: Once per week during 12 week study
|
minutes spent measuring coagulation time of blood on standard versus home protocol
|
Once per week during 12 week study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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. |
During study vist number 2 after 12 week study period, repeated after second study 12 week period study visit #3
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather Gornik, M.D., The Cleveland Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- vMetrics-AMS-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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