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

TREATS-AF Study Group; Arintaya Phrommintikul; Surakit Nathisuwan; Siriluck Gunaparn; Rungroj Krittayaphong; Wanwarang Wongcharoen; Sukhi Sehmi; Samir Mehta; Neil Winkles; Peter Brocklehurst; Jonathan Mathers; Sue Jowett; Kate Jolly; Deirdre Lane; G Neil Thomas; Gregory Y H Lip

doi:10.1136/bmjopen-2021-051987

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

TREATS-AF Study Group, Arintaya Phrommintikul, Surakit Nathisuwan, Siriluck Gunaparn, Rungroj Krittayaphong, Wanwarang Wongcharoen, Sukhi Sehmi, Samir Mehta, Neil Winkles, Peter Brocklehurst, Jonathan Mathers, Sue Jowett, Kate Jolly, Deirdre Lane, G Neil Thomas, Gregory Y H Lip

Research output: Contribution to journal › Article › peer-review

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Abstract

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.

Original language	English
Article number	e051987
Number of pages	9
Journal	BMJ open
Volume	11
Issue number	10
DOIs	https://doi.org/10.1136/bmjopen-2021-051987
Publication status	Published - 11 Oct 2021

Bibliographical note

Funding Information:
Funding This study is supported by the Newton Fund through the collaboration of the Medical Research Council, the UK (grant reference number: MR/R020892/1) and the Thailand Research Fund, Thailand (grant reference number: DBG6180009).

Publisher Copyright:
© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Keywords

Adolescent
Adult
Anticoagulants/therapeutic use
Atrial Fibrillation/complications
Humans
Prospective Studies
Quality of Life
Randomized Controlled Trials as Topic
Stroke/prevention & control
Thailand
Treatment Outcome
cardiology
qualitative research
health economics

ASJC Scopus subject areas

General Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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TREATS-AF: Educational intervention vs usual care on anticoagulation therapy control based on a SAMe-TT2R2 score-guided strategy
Thomas, N. (Co-Investigator), Jowett, S. (Co-Investigator), Mathers, J. (Co-Investigator), Brocklehurst, P. (Co-Investigator), Shantsila, A. (Co-Investigator), Jolly, K. (Co-Investigator), Slade, A. (Co-Investigator), Windridge, D. (Co-Investigator), Gough, R. (Co-Investigator), Gough, R. (Co-Investigator), Gough, R. (Co-Investigator) & Lip, G. (Principal Investigator)
Medical Research Council
1/04/18 → 31/03/23
Project: Research Councils

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TREATS-AF Study Group, Phrommintikul, A., Nathisuwan, S., Gunaparn, S., Krittayaphong, R., Wongcharoen, W., Sehmi, S., Mehta, S., Winkles, N., Brocklehurst, P., Mathers, J., Jowett, S., Jolly, K., Lane, D., Thomas, G. N., & Lip, G. Y. H. (2021). 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. BMJ open, 11(10), Article e051987. https://doi.org/10.1136/bmjopen-2021-051987

TREATS-AF Study Group ; Phrommintikul, Arintaya ; Nathisuwan, Surakit et al. / 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. In: BMJ open. 2021 ; Vol. 11, No. 10.

@article{90ff48bb41cb4bbc9a01bc74b8020396,

title = "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-na{\"i}ve Thai patients with atrial fibrillation (TREATS-AF): a study protocol",

abstract = "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-na{\"i}ve 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 na{\"i}ve. 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.",

keywords = "Adolescent, Adult, Anticoagulants/therapeutic use, Atrial Fibrillation/complications, Humans, Prospective Studies, Quality of Life, Randomized Controlled Trials as Topic, Stroke/prevention & control, Thailand, Treatment Outcome, cardiology, qualitative research, health economics",

author = "{TREATS-AF Study Group} and Arintaya Phrommintikul and Surakit Nathisuwan and Siriluck Gunaparn and Rungroj Krittayaphong and Wanwarang Wongcharoen and Sukhi Sehmi and Samir Mehta and Neil Winkles and Peter Brocklehurst and Jonathan Mathers and Sue Jowett and Kate Jolly and Deirdre Lane and Thomas, {G Neil} and Lip, {Gregory Y H}",

note = "Funding Information: Funding This study is supported by the Newton Fund through the collaboration of the Medical Research Council, the UK (grant reference number: MR/R020892/1) and the Thailand Research Fund, Thailand (grant reference number: DBG6180009). Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.",

year = "2021",

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doi = "10.1136/bmjopen-2021-051987",

language = "English",

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TREATS-AF Study Group, Phrommintikul, A, Nathisuwan, S, Gunaparn, S, Krittayaphong, R, Wongcharoen, W, Sehmi, S , Mehta, S, Winkles, N, Brocklehurst, P, Mathers, J, Jowett, S , Jolly, K , Lane, D , Thomas, GN & Lip, GYH 2021, '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', BMJ open, vol. 11, no. 10, e051987. https://doi.org/10.1136/bmjopen-2021-051987

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. / TREATS-AF Study Group; Phrommintikul, Arintaya; Nathisuwan, Surakit et al.
In: BMJ open, Vol. 11, No. 10, e051987, 11.10.2021.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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)

T2 - a study protocol

AU - TREATS-AF Study Group

AU - Phrommintikul, Arintaya

AU - Nathisuwan, Surakit

AU - Gunaparn, Siriluck

AU - Krittayaphong, Rungroj

AU - Wongcharoen, Wanwarang

AU - Sehmi, Sukhi

AU - Mehta, Samir

AU - Winkles, Neil

AU - Brocklehurst, Peter

AU - Mathers, Jonathan

AU - Jowett, Sue

AU - Jolly, Kate

AU - Lane, Deirdre

AU - Thomas, G Neil

AU - Lip, Gregory Y H

N1 - Funding Information: Funding This study is supported by the Newton Fund through the collaboration of the Medical Research Council, the UK (grant reference number: MR/R020892/1) and the Thailand Research Fund, Thailand (grant reference number: DBG6180009). Publisher Copyright: © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

PY - 2021/10/11

Y1 - 2021/10/11

N2 - 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.

AB - 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.

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KW - Atrial Fibrillation/complications

KW - Humans

KW - Prospective Studies

KW - Quality of Life

KW - Randomized Controlled Trials as Topic

KW - Stroke/prevention & control

KW - Thailand

KW - Treatment Outcome

KW - cardiology

KW - qualitative research

KW - health economics

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DO - 10.1136/bmjopen-2021-051987

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TREATS-AF Study Group, Phrommintikul A, Nathisuwan S, Gunaparn S, Krittayaphong R, Wongcharoen W et al. 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. BMJ open. 2021 Oct 11;11(10):e051987. doi: 10.1136/bmjopen-2021-051987