None listed
Conditions
Interventions
Eligible patients are randomly allocated to either on-going Usual Care (International Normalised Ratio (INR) management by their local doctor or hospital clinic) or to Self Management (testing INR at home with an investigational device and dosing algorithm) for a 12-month period.
Patients allocated to the Self Management group receive three 90-minute training sessions in (i) the therapeutic use of warfarin (also attended by the Usual Care group), (ii) practical use of the device (CoaguChek S),
Eligible patients are randomly allocated to either on-going Usual Care (International Normalised Ratio (INR) management by their local doctor or hospital clinic) or to Self Management (testing INR at home with an investigational device and dosing algorithm) for a 12-month period. Patients allocated to the Self Management group receive three 90-minute training sessions in (i) the therapeutic use of warfarin (also attended by the Usual Care group), (ii) practical use of the device (CoaguChek S), and, (iii) implementing the self-dosing algorithm (a colour-coded INR warfarin-dosing algorithm). This algorithm uses small dose adjustments (5-33% of the maintenance dose is used) according to AHA guidelines, to maintain tight control. Fortnightly Diary - All patients report to the Study Coordinator fortnightly by completing the fortnightly diary for the 12-month study period. This is an easy to complete form with closed and open-ended questions. It gathers information related to any illnesses, complications of warfarin therapy, new medications commenced and surgical procedures performed. Outcome INR - All patients have an outcome INR tested monthly for 12 months. The Outcome INR’s are carried out at one laboratory in order to eliminate interlab variability. This INR is not used in either group to regulate warfarin dose, it is purely to allow for statistical analysis of equal numbers of variables in both groups. Testing Frequency - The Usual Care group are managed by their GP who will test the INR and dose the warfarin at least once per month. These results are logged and returned to the study coordinator. Self Management patients check their INR weekly with the device at home. The frequencies of testing and dose adjustments are specified in the algorithm (Colourchart) that is specific to this trial (i.e. if in therapeutic range the patients tests every 7 days but if their INR varies above or below range it is checked in 2 days and dose adjustments are made accordingly). Quality of Life - In order to assess the patients quality of life, all patients complete a treatment related, structured questionnaire at baseline, 6 months and on completion of the 12-month study period
Sponsors
Royal Prince Alfred Hospital Cardiothoracic Department
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has one or more mechanical valve(s) or chronic (greater than 3 months) Atrial Fibrillation. 2. Patient has been taking Warfarin/Coumadin for at least 3 months. 3. Patients INR has been in therapeutic range for > 2 weeks. 4. Patient has had no more than a <2mg change in their warfarin dose in the last four weeks. 5. Patient speaks English. 6. Patient can read English. 7. Patient has access to a telephone.
Exclusion criteria
1. Patient is known to have a coagulation disorder2. Patient has known underlying liver disease3. Patient has a drug or alcohol addiction that is likely to limit compliance with the study routine.4. Patient has a visual deficit likely to limit compliance.5. Patient failed the mini mental test (AMT)6. Patient has any other condition that is likely to limit compliance (e.g. tremor or tactile dysfunction).
Outcome results
None listed