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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00978445
Recruitment Status : Completed
First Posted : September 17, 2009
Results First Posted : March 21, 2013
Last Update Posted : March 21, 2013
The Cleveland Clinic
Information provided by (Responsible Party):
Carlos Grodsinsky, ZIN Technologies, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Venous Thromboembolism
Intervention: Other: vMetrics protocol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Inrolled 25 patients in two arms of 12 weeks from patient population of Cleveland Clinic Foundation

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Clear enrollement criteria were created only real exclusion was if physician did not believe patient could perform protocol and if outside of age criteria.

Reporting Groups
Home/Standard all participants recieved home and standard protocol, in this ARM the home protocol was a virtual INR and communication using a remote communication device called vMetrics.
Standard/Home all participants recieved home and standard protocol, in this ARM the standard protocol was a in clinic INR and interaction with a care giver, then the Home protocol was as described.

Participant Flow:   Overall Study
    Home/Standard   Standard/Home
STARTED   12   13 
COMPLETED   10   12 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
All Participants all participants recieved all interventions during study

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   25 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 53.7  (11.7) 
[Units: Participants]
Female   10 
Male   15 
Region of Enrollment 
[Units: Participants]
United States   25 

  Outcome Measures

1.  Primary:   Time Spent Per PT/INR Monitoring Encounter   [ Time Frame: Once per week during 12 week study ]

2.  Secondary:   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 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Heather Gornik
Organization: Cleveland Clinic Foundation
phone: 216-445-3689

Responsible Party: Carlos Grodsinsky, ZIN Technologies, Inc. Identifier: NCT00978445     History of Changes
Other Study ID Numbers: vMetrics-AMS-01
First Submitted: September 15, 2009
First Posted: September 17, 2009
Results First Submitted: July 18, 2012
Results First Posted: March 21, 2013
Last Update Posted: March 21, 2013