Venous ThromboembolismvMetrics-AMSNCT00978445
Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System
A study testing vMetrics protocol in people with Venous Thromboembolism, run by ZIN Technologies, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- vMetrics protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of a Novel Remote Home PT/INR-monitoring Device for Long-Term Anticoagulation Management
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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Being tested
- vMetrics protocol
- Keywords
- Systemic embolic events, Thromboembolic Complications with Atrial Fibrillation, Prophylaxis with Atrial Fibrillation, Mechanical Cardiac Valve Replacement
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vMetrics protocolOther
use vmetrics protocol and device or use standard in clinic monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: vMetrics protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Spent Per PT/INR Monitoring Encounter
minutes spent measuring coagulation time of blood on standard versus home protocol
Measured: 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
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.
Measured: During study vist number 2 after 12 week study period, repeated after second study 12 week period study visit #3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZIN Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Carlos Grodsinsky, ZIN Technologies, Inc.
- Investigators
- Heather Gornik, M.D., Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978445
- Sponsor's protocol ID
- vMetrics-AMS-01
- Acronym
- vMetrics-AMS
- Status last verified
- Mar 2013
- First submitted
- 15 Sep 2009
- Last updated
- 21 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Novel Remote Home PT/INR-monitoring Device for Long-Term Anticoagulation Management
- ClinicalTrials.gov ID
- NCT00978445
- Acronym / sponsor ID
- vMetrics-AMS / vMetrics-AMS-01
- Conditions
- Venous Thromboembolism
- Keywords
- Systemic embolic events, Thromboembolic Complications with Atrial Fibrillation, Prophylaxis with Atrial Fibrillation, Mechanical Cardiac Valve Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ZIN Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 17 Sep 2009 (estimated)
- Results
- Posted 21 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home/Standard | Experimental | Other: vMetrics protocolall 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. |
| Standard/Home | Experimental | Other: vMetrics protocolall 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Ages 18-80 years
- Requires long-term oral anticoagulation therapy for one of the following indications:
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vMetrics protocoluse vmetrics protocol and device or use standard in clinic monitoring | Other | Home/Standard, Standard/Home |
Primary outcome
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
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Gornik, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vMetrics protocol in people with Venous Thromboembolism, run by ZIN Technologies, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Spent Per PT/INR Monitoring Encounter (time frame: Once per week during 12 week study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2013.