TREATS-AF
The TREATS-AF Trial: A prospective randomised trial examining the impact of an intensive educational intervention versus usual care on anticoagulation therapy control intervention based on SAMe-TT2R2 score-guided strategy in anticoagulant-naïve Thai patients with atrial fibrillation (TREATS-AF).
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A prospective randomised trial examining the impact of an intensive educational intervention versus usual care on anticoagulation therapy control intervention based on SAMe-TT2R2 score-guided strategy in anticoagulant-naïve Thai patients with atrial fibrillation (TREATS-AF).
The aim is to conduct a randomised-controlled trial (RCT) in Thai patients with atrial fibrillation (AF) 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. Depending on the clinical prediction score participants will be assigned to receive either an educational-behavioural intervention in addition to their routine care to improve their time in therapeutic range (TTR) on warfarin or usual care alone.
The TREATS-AF study is funded by the Medical Research Council (MRC) and the Thailand Research Fund (TRF).
The TREATS-AF Trial is currently being conducted in Thailand.
The TREATS-AF trial is a multi-centre open-label randomised controlled trial. Patients will be randomised to the intervention (extra education, plus usual care) or control arm (usual care).
The primary objective of this trial is to assess if greater AF and anticoagulation knowledge and understanding improves INR control in the intervention group compared to those receiving usual care.
The target population are adults (≥18 years), who have been newly diagnosed non-valvular AF and are warfarin-eligible and warfarin-naïve (no treatment with warfarin within the past 12 months).
The target sample size is 320.
The intervention the participant will receive will be either:
Group 1: Usual care [warfarin plus usual care].
OR
Group 2: Care pathway designated based on stratification of patients using the modified SAMe-TT2R2 score.
Group 2a: Modified SAMe-TT2R2 score 0-2 [warfarin plus usual care].
Group 2b: Modified SAMe-TT2R2 score >2 group [warfarin plus intensive TREAT education behavioural intervention as an adjunct to their regular INR monitoring to improve their TTR on warfarin].
Some of the TREATS-AF team members from Thailand and the UK:
Top row from left across: Antika Nong (Statistician), Praphaphan Daoram (Data Manager) and Siriluck Gunaparn (Project Manager), Sukhi Sehmi (Project Manager), Unchalee Permsuwan, (Health Economics), Tomorn Thongsri (TSC member) and Smonporn Boonyaratavej (TSC Chair).
Middle row from left across: Rapeephon Kunjara (Co-investigator), Kemmawadee Preedalikit (DMEC member), Neil Thomas (Co-investigator), Sue Jowett (Co-investigator) and Kate Jolly (Co-investigator).
Bottom row from left across: Gregory Lip (Principle Investigator), Rungroj Krittiyaphong (Co-investigator), Surakit Nathisuwan (Co-investigator), Arintaya Phrommintikul (Co-investigator) and Neil Winkles (Programmer).
