Plain English Summary
Background and study aims
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. 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.
The aim of this study is to conduct a study 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. Depending on the score participants will be given an educational-behavioural intervention as an addition to their routine care to improve their time in therapeutic range (TTR) on warfarin.
Who can participate?
Men and women aged 18 and over who have been newly diagnosed with non-valvular AF
What does the study involve?
Participants will attend five hospital visits throughout the duration of the study. Each visit will take about 30 minutes and involve physical examinations, blood tests and clinical assessments. Participants will be asked to provide their personal information, medical history and medications they are currently taking. They will be asked to complete a series of questionnaires to measure their life quality and the expenses for medical treatment that they pay for. Participants will also be offered to take part in a sub-study exploring patient satisfaction and acceptance of the TREATS intervention approach.
Eligible participants will be randomly allocated into one of two groups. One group will continue to receive their current usual care; the other group will also continue to receive usual care but also have the extra education (the TREAT intervention) given to them. The intervention group will be provided with additional information on how to use warfarin effectively. This will be carried out by face-to-face discussion, viewing a video and receiving a booklet. The duration of this activity will take about 30 minutes.
What are the possible benefits and risks of participating?
Participants may not directly benefit from their participation in this study. However, the information from this study could further benefit patients with atrial fibrillation who are treated with Warfarin. There are no additional risks involved over those of standard care.
Where is the study run from?
Chiang Mai University (Thailand)
Who is funding the study?
1. Medical Research Council (UK)
2. National Research Council of Thailand (Thailand)
3. Newton Fund (UK)
Who is the main contact?
Sukhi Sehmi
s.sehmi@bham.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Prof Arintaya Phrommintikul
ORCID ID
http://orcid.org/0000-0003-3986-1951
Contact details
Department of Internal Medicine
Faculty of Medicine
Chiang Mai University
Muang Chiang Mai
Chiang Mai
50200
Thailand
+66 (0)5393 6793
arintaya.p@cmu.ac.th
Type
Scientific
Additional contact
Prof Gregory Lip
ORCID ID
http://orcid.org/0000-0002-7566-1626
Contact details
Liverpool Centre for Cardiovascular Science
University of Liverpool
William Henry Duncan Building
6 West Derby Street
Liverpool
L7 8TX
United Kingdom
+44 (0)151 794 9020
gregory.lip@liverpool.ac.uk
Type
Scientific
Additional contact
Ms Sukhi Sehmi
ORCID ID
Contact details
Senior Trial Manager
Birmingham Clinical Trials Unit
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 415 8445
treatsaf@trials.bham.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
TCTR20180711003, MR/R020892/1, DBG6180009
Study information
Scientific title
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)
Acronym
TREATS-AF
Study hypothesis
Primary hypotheses:
The SAMe-TT2R2 score guided strategy and educational intervention group have more time in the therapeutic range at 12 months than the usual care group.
Secondary hypotheses:
1. The SAMe-TT2R2 score guided strategy and educational intervention group have more time in the therapeutic range at 6 months than the usual care group.
2. The number of thromboembolic and bleeding events in The SAMe-TT2R2 score guided strategy of educational intervention group is less than the usual care group.
3. The number of major adverse cardiovascular events (MACE) in the SAMe-TT2R2 score guided strategy of educational intervention group is less than the usual care group.
4. The SAMe-TT2R2 score guided strategy of educational intervention group have better AF knowledge than the usual care group.
Ethics approval
Approved 08/01/2020, Central Research Ethics Committee (CREC) (5th Fl Building 2, The National Research Council of Thailand Paholyothin Rd., Bangkhen, Bangkok 10900, Thailand; +66 (0)2 579 0117; crec_thailand@hotmail.com), ref: CREC053/62BPm
Study design
Multicenter open-label randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
No participant information sheet available
Condition
Patients diagnosed with new-onset, non-valvular atrial fibrillation and warfarin naïve
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.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Time in the Therapeutic Range (TTR) measured by INR level at 12 months
Secondary outcome measures
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
Overall trial start date
01/04/2018
Overall trial end date
31/12/2021
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
320
Participant exclusion criteria
1. Any contraindication to oral anticoagulants
2. Prosthetic cardiac valve or significant valvular heart disease with an indication for heart surgery
3. Likelihood of intermittent or permanent discontinuation of warfarin during follow up, e.g. major surgery or post AF ablation
4. Known active malignancy
5. Diagnosed cognitive impairment
6. Any disease likely to cause death within 12 months
7. Unable to provide written informed consent
Recruitment start date
31/01/2020
Recruitment end date
31/05/2021
Locations
Countries of recruitment
Thailand
Trial participating centre
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
50200
Thailand
Trial participating centre
ChiangRai Prachanukroh Hospital
Chiang Rai
57000
Thailand
Trial participating centre
Nakornping Hospital
Chiang Mai
50180
Thailand
Trial participating centre
Lampang Hospital
Lampang
52100
Thailand
Trial participating centre
Siriraj Hospital
Bangkok
10700
Thailand
Trial participating centre
Maharat Nakhon Ratchasima Hospital
Nakhon Ratchasima
30000
Thailand
Trial participating centre
Queen Sirikit Heart Center of the Northeast and Srinagarind Hospital
Khon Kaen
40002
Thailand
Sponsor information
Organisation
Chiang Mai University
Sponsor details
Faculty of Medicine
Muang Chiang Mai
Chiang Mai
50200
Thailand
+66 (0)5393 6209
researchmed@cmu.ac.th
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
Medical Research Council
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
National Research Council of Thailand
Alternative name(s)
NRCT
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Thailand
Funder name
Newton Fund
Alternative name(s)
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. No additional documents are available.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Thailand Chief Investigator Arintaya Phrommintikul (arintayap@gmail.com).
Intention to publish date
30/12/2022
Participant level data
Available on request
Basic results (scientific)
Publication list