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Patient Self Testing of Warfarin Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by University College Cork.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Hoffmann-La Roche
Irish Health Research Board
ZyCare Inc
Information provided by:
University College Cork
ClinicalTrials.gov Identifier:
NCT00594828
First received: January 7, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

To test the hypothesis that home international normalised ratio (INR) monitoring with supervised patient self-testing (PST)can provide comparable or superior time in therapeutic range (TTR) to that provided by traditional outpatient anticoagulation.


Condition Intervention Phase
Warfarin
 Device: CoaguChek (Patient self testing)
Device: Anticoagulation Management Service (AMS)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Patient Self-Testing of Warfarin Therapy Using an Internet Based Expert System

Resource links provided by NLM:

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Further study details as provided by University College Cork:

Primary Outcome Measures:
  • The primary outcome variable used to assess therapeutic efficacy and safety will be the difference in TTR during the six months of AMS management and the six months of PST [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the number of adverse events (haemorrhagic and thromboembolic) using PST and AMS management [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 163
Study Start Date: July 2006
Estimated Study Completion Date: April 2008
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
6 months of supervised patient self testing using an expert system
 Device: CoaguChek (Patient self testing)
Patients will test their INR at home either biweekly, weekly or every 2 weeks using a CoaguChek point of care meter and communicate with the healthcare provider via an internet based expert system
Other Names:
  • CoaguChek S point of care meter
  • CoaguChek XS point of care meter
  • CoagCare expert system
Active Comparator: 2
6 months of routine medical care by the anticoagulation management service
 Device: Anticoagulation Management Service (AMS)
Patients will attend the AMS for six months and have their INR checked every 4-6 weeks or more frequently, at the discretion of the clinician

Detailed Description:

Indications for anticoagulant treatment to prevent thromboembolic disease have increased in recent years. INR must be monitored frequently to determine the safest dose and to minimize the risk for thrombotic and haemorrhagic complications. Standard warfarin therapy is associated with rates of major haemorrhage of up to 5-9% annually and recurrent venous thromboembolism of up to 8%. These event rates are dependent of the model of care used to manage warfarin therapy, with better outcomes associated with home testing of the INR which enables patients to monitor their response to warfarin more frequently. INR results must still be 'managed' by communicating the data to the healthcare provider, usually be telephone or fax.

In this study we will evaluate a novel method of PST; supervised PST with an internet based expert system, which 'manages' patients on oral anticoagulation by utilizing clinical and laboratory data provided by the patient and dose adjustment and retesting algorithms derived from clinical practice. Patients will be randomized to either 6 months of supervised PST or routine medical care by the AMS. At the end of the 6 month period, each patient will then 'cross over' to the other management regimen and the difference in TTR between the two periods will be compared.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • on warfarin therapy for a minimum of 2 months
  • are expected to be on warfarin therapy for the duration of the 12 month study
  • internet access

Exclusion Criteria:

  • inability to provide informed consent
  • inability to use a home INR meter
  • patients who do not have a telephone
  • more than 2 missed clinic appointments in the preceding 6 months
  • patients on anticoagulant drugs other than warfarin (eg heparin, low molecular weight heparin)
  • history of hemorrhagic complications with a therapeutic or therapeutic INR in the preceding 6 months
  • inability to attend the hospital at short notice, if necessary
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594828

Locations
Ireland
Cork University Hospital
Cork, Ireland
Sponsors and Collaborators
University College Cork
Hoffmann-La Roche
Irish Health Research Board
ZyCare Inc
Investigators
Principal Investigator: Susan J O'Shea, MD Cork University Hospital
  More Information

No publications provided

Responsible Party: Dr Susan O'Shea, University College Cork
ClinicalTrials.gov Identifier: NCT00594828     History of Changes
Other Study ID Numbers: PA/05/16
Study First Received: January 7, 2008
Last Updated: January 7, 2008
Health Authority: Ireland: Irish Medicines Board
Ireland: Medical Ethics Research Committee

Keywords provided by University College Cork:
Patient self-testing
Oral anticoagulation therapy
Expert Systems
Point-of-Care Systems
International Normalized Ratio

Additional relevant MeSH terms:
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2012