TREATS-AF:Educational intervention vs usual care on anticoagulation therapy control based on a SAMe-TT2R2 score-guided strategy

需要抗凝剂（“血液稀释剂”）来预防房颤（AF）患者的中风和死亡。AF是世界上最常见的不规则心跳形式，包括在泰国。抗凝是AF患者预防卒中发生的主要治疗方法。Warfarin是泰国最常用的抗凝剂，但由于它受许多饮食和患者因素的影响，很难实现良好的抗凝控制。在泰国，正因为如此，大多数患者在使用华法林时抗凝控制不足，我们的目的是在泰国AF患者中进行一项随机对照试验（RCT），这些患者以前没有使用过抗凝剂，以评估简单临床预测评分的使用（SAMe-TT 2 R2），以帮助确定那些患者可能有良好的反应与华法林抗凝治疗相比，常规护理。预测反应较差的患者（SAMe-TT 2 R2>2）将根据我们之前的随机对照试验（TREAT试验）接受教育行为干预，作为常规护理的补充，以提高他们对华法林的TTR。在本项目中，我们将首先对TREAT干预措施进行文化适应，并对患者知识问卷进行翻译、翻译和验证，以确保适用于泰国，并将包括一项定性研究，探讨患者对TREAT方法的满意度和接受程度，并评估该策略对医疗保健成本的影响。此外，我们将评估泰国医疗保健系统干预的成本效益，并探讨与干预相关的复合临床结局。这项研究如果成功，将提供一种廉价，简单的方法，可以很容易地整合到现有的泰国卫生服务，以改善AF患者的健康，降低中风和相关死亡的风险。它还将使我们了解患者对治疗的看法，我们可以利用这些看法来改进我们的方法。这项合作研究还将促进英国和泰国之间的进一步研究，并开发新的以患者为中心的工具（例如泰国版的TREAT教育干预，泰语问卷等）。

Anticoagulants ('blood thinners') are needed to prevent stroke and death in patients with atrial fibrillation (AF). AF is the world's most common form of irregular heartbeat, including in Thailand. Anticoagulation is a mainstay treatment in AF patients to prevent strokes occurring. Warfarin is the most commonly used anticoagulant in Thailand, but because it is influenced by many diet and patient factors it can be difficult to achieve good anticoagulation control. In Thailand, because of this, most patients receive inadequate control of their anticoagulation when using warfarin, leading to increased risk of stroke and death.Our 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. In this project, we will first undertake cultural adaptation of the TREAT intervention and translation, translation and validation of the patient knowledge questionnaire to ensure applicability to Thailand, and will include a qualitative study exploring patient satisfaction and acceptance of the TREAT approach and assess the impact on healthcare costs of this strategy. In addition, we would assess cost-effectiveness of the intervention in the Thailand healthcare system, and also explore composite clinical outcomes related to the intervention. This study, if successful, will provide an inexpensive, easy approach that can be readily integrated into the existing Thai health service to improve the health of those patients with AF reducing both their risk of stroke and associated death. It will also give us an understanding of patients' perceptions of the treatment which we may be able to use to improve our approach. This collaborative study will also facilitate further research between the UK and Thailand and development of new patient-centred tools (e.g. Thai-version of TREAT educational intervention, Thai-language questionnaires, etc.).