Patient Self Testing of Warfarin Therapy

NCT ID: NCT00594828

Last Updated: 2008-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-04-30

Brief Summary

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.

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.

Conditions

Warfarin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

6 months of supervised patient self testing using an expert system

Group Type: EXPERIMENTAL

CoaguChek (Patient self testing)

Intervention Type: DEVICE

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

2

6 months of routine medical care by the anticoagulation management service

Group Type: ACTIVE_COMPARATOR

Anticoagulation Management Service (AMS)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

Other Intervention Names

CoaguChek S point of care meter; CoaguChek XS point of care meter; CoagCare expert system

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Health Research Board, Ireland

OTHER

Sponsor Role: collaborator

ZyCare Inc

INDUSTRY

Sponsor Role: collaborator

University College Cork

OTHER

Sponsor Role: lead

Responsible Party

University College Cork

Principal Investigators

Susan J O'Shea, MD

Role: PRINCIPAL_INVESTIGATOR

Cork University Hospital

Locations

Cork University Hospital

Cork, Cork, Ireland

Countries

Ireland

Other Identifiers

PA/05/16

Identifier Type: -

Identifier Source: org_study_id