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
Results First Received: July 18, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Venous Thromboembolism
Intervention: Other: vMetrics protocol

  Participant Flow
  Hide 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
  Description
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  
NOT COMPLETED     2     1  



  Baseline Characteristics
  Hide 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
  Description
All Participants all participants recieved all interventions during study

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  25  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  53.7  ± 11.7  
Gender  
[units: participants]
 
Female     10  
Male     15  
Region of Enrollment  
[units: participants]
 
United States     25  



  Outcome Measures
  Show All 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
  Hide 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
none


  More Information
  Hide 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
e-mail: gornikh@ccf.org


No publications provided


Responsible Party: Carlos Grodsinsky, 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