Prospective randomised trial examining the impact of an educational intervention versus usual care on anticoagulation therapy control based on an SAMe-TT2R2 score-guided strategy in anticoagulant-naïve Thai patients with atrial fibrillation (TREATS-AF): a study protocol
Kate Jolly,
Gregory Y H Lip,
Anita Slade,
Jonathan Mathers,
Sue Jowett,
Gemma Slinn,
Peter Brocklehurst,
Arintaya Phrommintikul,
G Neil Thomas,
Samir Mehta,
Antika Wongthanee,
Rungroj Krittayaphong,
Deirdre Lane,
Surakit Nathisuwan,
Siriluck Gunaparn,
Wanwarang Wongcharoen,
Sukhi Sehmi,
Neil Winkles,
Narawudt Prasertwitayakij,
Wattana Wongtheptien,
Thanyaluck Chotayaporn,
Natrawee Bureekam,
Bancha Sookananchai,
Vichai Senthong
Affiliations
Kate Jolly
1 Institute of Applied Health Research, University of Birmingham, Birmingham, UK
Gregory Y H Lip
Department of Clinical Medicine, Aalborg Universitet, Aalborg, Denmark
Anita Slade
Jonathan Mathers
Institute of Applied Health Research, University of Birmingham, Birmingham, UK
Sue Jowett
Health Economics Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
Gemma Slinn
Peter Brocklehurst
Institute of Applied Health Research, University of Birmingham, Birmingham, UK
Arintaya Phrommintikul
Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
G Neil Thomas
Department of Public Health and Epidemiology, Institute of Applied Health Research, University of Birmingham, Birmingham, UK
Samir Mehta
Clinical Trials Unit, University of Birmingham, Birmingham, UK
Antika Wongthanee
Rungroj Krittayaphong
Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
Deirdre Lane
Department of Cardiovascular and Metabolic Medicine, University of Liverpool, Liverpool, UK
Surakit Nathisuwan
4 Department of Pharmacy, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand
Siriluck Gunaparn
Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Wanwarang Wongcharoen
Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
Sukhi Sehmi
Clinical Trials Unit, University of Birmingham, Birmingham, UK
Neil Winkles
Clinical Trials Unit, University of Birmingham, Birmingham, UK
Introduction The burden of atrial fibrillation (AF) in Thailand is high and associated with increased morbidity, mortality and healthcare costs. Vitamin K antagonists (eg, warfarin), commonly used for stroke prevention in patients with AF in Thailand, are effective but are often suboptimally controlled. We aim to evaluate the impact of an SAMe-TT2R2 score-guided strategy and educational intervention compared to usual care on anticoagulation control expressed by the time in therapeutic range (TTR) at 12 months, in anticoagulant-naïve Thai patients with AF.Methods and analysis Multicentre, open-label, parallel-group, randomised controlled trial conducted in Thailand among adult patients (age: 18 years) with AF who are anticoagulant naïve. Patients will be randomised to one of two groups; an SAMe-TT2R2 score-guided strategy with educational intervention and usual care versus usual care alone. The planned follow-up period is 12 months. The primary outcome is TTR at 12 months. Secondary outcomes include: (1) TTR at 6 months; (2) thromboembolic and bleeding events at 12 months; (3) composite major adverse cardiovascular events at 12 months; (4) change in patients’ knowledge of AF between baseline and 6 months and 12 months; (5) cost effectiveness; (6) quality of life at baseline, 6 months and 12 months using EQ-5D-5L (Thai version) and (7) patient satisfaction/perceptions of the TREAT intervention. An embedded qualitative study will assess patient perceptions of the TREAT intervention.Ethics and dissemination The study has been approved by the Ethical Review Committee, Ministry of Public Health of Thailand, and registered in the Thai Clinical Trials Registry. The results of this trial will be submitted for publication in a peer-reviewed journal. Participants will be informed via a link to a preview of the publication. A lay summary will also be provided to all participants prior to publication.Trial registration number TCTR20180711003.
