RecruitingPhase 3ACTRN12606000019505

Self Management of Anticoagulation Research Trial

A Study to Evaluate the Impact of Patient Self Management on Oral Anticoagulation of Patients with Mechanical Heart Valve Replacement and/or Chronic Atrial Fibrillation

Sponsor

Royal Prince Alfred Hospital Cardiothoracic Department

Enrollment

300 participants

Start Date

Jan 21, 2004

Study Type

Interventional

Conditions

Oral Anticoagulation

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients taking warfarin (a blood-thinning medicine) can safely manage their own anticoagulation at home using a finger-prick testing device, instead of making regular visits to a clinic for blood tests. Self-management involves patients testing their own INR (a measure of blood clotting) and adjusting their warfarin dose when needed. This could give patients more control and convenience. You may be eligible if: - You are 18 years or older - You have a mechanical heart valve or long-term (more than 3 months) atrial fibrillation and need warfarin - You have been taking warfarin for at least 3 months - Your INR has been in the target range for more than 2 weeks - Your warfarin dose has not changed by more than 2mg in the last 4 weeks - You can read and speak English - You have access to a telephone You may NOT be eligible if: - You have a known blood clotting disorder - You have known liver disease - You have a drug or alcohol addiction that may affect your ability to follow the study routine - You have significant visual problems - You failed the mental capacity screening test (AMT) - You have another condition that would prevent you from reliably self-managing (e.g., tremor, poor touch sensation) Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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

Locations(1)

Australia

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ACTRN12606000019505

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