Education programme to help improve patient's knowledge and understanding of atrial fibrillation and warfarin control in Thailand

INTERVENTION: The aim is to conduct a randomised‐controlled trial (RCT) in Thai AF patients who have not used an anticoagulant before to evaluate the use of a simple clinical prediction score (SAMe‐TT2R2) to help identify those patients likely to have a good response to anticoagulation with warfarin, compared with usual care. Predicted poorer responders (SAMe‐TT2R2 >2) will be given an educational‐behavioural intervention based on our previous RCT (TREAT trial) as an addition to routine care to improve their TTR on warfarin. Method: Open‐label RCT; 9‐month recruitment period, 12‐months follow‐up. Randomization will be done using a web‐based platform with blinded allocation. Randomization will be stratified based on centre, sex (male or female) and baseline SAMe‐TT2R2 score (0‐2, 3‐5, 6‐8). Eligible participants will be randomized to one of two groups: usual care vs SAMe‐TT2R2 score‐guided warfarin (i.e. score 0‐2: usual care alone; score >2: usual care plus TREAT educational‐behavioural intervention as an adjunct to their regular INR monitoring to improve their TTR on warfarin). Participants will attend five hospital visits throughout the duration of the study. Each visit will take approximately 30 minutes and involve physical examinations, blood tests and clinical assessments. CONDITION: Patients diagnosed with new‐onset, non‐valvular atrial fibrillation and warfarin naïve ; Circulatory System ; Atrial fibrillation and flutter PRIMARY OUTCOME: Time in the Therapeutic Range (TTR) measured by INR level at 12 months SECONDARY OUTCOME: ; 1. Time in the Therapeutic Range (TTR) measured by INR level at 6 months; 2. Patients’ knowledge measured by the atrial fibrillation knowledge scale questionnaire at baseline, 6 and 12 months; 3. Quality of life measured by the EQ‐5D‐5L questionnaire at baseline, 6 and 12 months; 4. Cost‐effectiveness measured by CRF questionnaire at 6 and 12 months; 5. Cardiovascular event measured by the number of events recorded at 12 months; INCLUSION CRITERIA: 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