Education programme to help improve patient's knowledge and understanding of atrial fibrillation and warfarin control in Thailand
- Conditions
- Patients diagnosed with new-onset, non-valvular atrial fibrillation and warfarin naïveCirculatory SystemAtrial fibrillation and flutter
- Registration Number
- ISRCTN11607760
- Lead Sponsor
- Chiang Mai University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 320
1. Newly diagnosed AF patients
2. Adults (aged =18 years) with ECG-documented non-valvular AF and =1 stroke risk factor (based on CHA2DS2VASc score)
3. Warfarin-eligible patients (men with CHA2DS2VASc score =1; women with CHA2DS2VASc score =2) who are warfarin-naïve (having never taken warfarin) will be considered for inclusion
1. Any contraindication to oral anticoagulants
2. Prosthetic cardiac valve or significant valvular heart disease with an indication for heart surgery
3. Likelihood of intermittent or permanent discontinuation of warfarin during follow up, e.g. major surgery or post AF ablation
4. Known active malignancy
5. Diagnosed cognitive impairment
6. Any disease likely to cause death within 12 months
7. Unable to provide written informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time in the Therapeutic Range (TTR) measured by INR level at 12 months
- Secondary Outcome Measures
Name Time Method 1. Time in the Therapeutic Range (TTR) measured by INR level at 6 months<br>2. Patients’ knowledge measured by the atrial fibrillation knowledge scale questionnaire at baseline, 6 and 12 months<br>3. Quality of life measured by the EQ-5D-5L questionnaire at baseline, 6 and 12 months <br>4. Cost-effectiveness measured by CRF questionnaire at 6 and 12 months<br>5. Cardiovascular event measured by the number of events recorded at 12 months