Patient Self Testing of Warfarin Therapy

NCT00594828 | Unknown Phase 4

• 1 other identifier: PA/05/16
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Warfarin

Keywords

Patient self-testing; Oral anticoagulation therapy; Expert Systems; Point-of-Care Systems; International Normalized Ratio

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (1)

• To compare the number of adverse events (haemorrhagic and thromboembolic) using PST and AMS management

  1 year

Study Arms (2)

1

EXPERIMENTAL

6 months of supervised patient self testing using an expert system

Device: CoaguChek (Patient self testing)

2

ACTIVE COMPARATOR

6 months of routine medical care by the anticoagulation management service

Device: Anticoagulation Management Service (AMS)

Interventions

CoaguChek (Patient self testing) 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

Also known as: CoaguChek S point of care meter, CoaguChek XS point of care meter, CoagCare expert system

1

Anticoagulation Management Service (AMS) 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

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Cork: lead
• Hoffmann-La Roche: collaborator
• Health Research Board, Ireland: collaborator
• ZyCare Inc: collaborator

Study Sites (1)

Cork University Hospital

Cork, Cork, Ireland

Location

Study Officials

• Susan J O'Shea, MD

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: July 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2008
• Last Updated: January 16, 2008

Record last verified: 2008-01

Locations

IE (1)