Education programme to help improve patient's knowledge and understanding of atrial fibrillation and warfarin control in Thailand
| ISRCTN | ISRCTN11607760 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11607760 |
| Secondary identifying numbers | TCTR20180711003, MR/R020892/1, DBG6180009 |
- Submission date
- 19/11/2020
- Registration date
- 03/12/2020
- Last edited
- 08/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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)
When is the study starting and how long is it expected to run for?
April 2018 to March 2023
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?
Prof. Gregory Lip
gregory.lip@liverpool.ac.uk
Contact information
Public
Department of Internal Medicine
Faculty of Medicine
Chiang Mai University
Muang Chiang Mai
Chiang Mai
50200
Thailand
 ORCID ID |
0000-0003-3986-1951 |
|---|---|
| Phone | +66 (0)5393 6793 |
| arintaya.p@cmu.ac.th |
Scientific
Liverpool Centre for Cardiovascular Science
University of Liverpool
William Henry Duncan Building
6 West Derby Street
Liverpool
L7 8TX
United Kingdom
| ORCID ID |
0000-0002-7566-1626 |
|---|---|
| Phone | +44 (0)151 794 9020 |
| gregory.lip@liverpool.ac.uk |
Study information
| Study design | Multicenter open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | No participant information sheet available |
| 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) |
| Study acronym | TREATS-AF |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2018 |
| Completion date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 320 |
| Total final enrolment | 320 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 31/01/2020 |
| Date of final enrolment | 31/10/2021 |
Locations
Countries of recruitment
- Thailand
Study participating centres
50200
Thailand
57000
Thailand
50180
Thailand
52100
Thailand
10700
Thailand
30000
Thailand
40002
Thailand
Sponsor information
University/education
Faculty of Medicine
Muang Chiang Mai
Chiang Mai
50200
Thailand
| Phone | +66 (0)5393 6209 |
|---|---|
| researchmed@cmu.ac.th | |
| Website | https://www.med.cmu.ac.th/ |
"ROR" |
https://ror.org/05m2fqn25 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- NRCT
- Location
- Thailand
Government organisation / National government
- Alternative name(s)
- The Newton Fund, NF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. No additional documents are available. |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 05/04/2024 | No | No | ||
| Results article | 08/10/2024 | 08/04/2025 | Yes | No |
Additional files
Editorial Notes
08/04/2025: Publication reference added.
05/04/2024: Baseline characteristics were uploaded as an additional file.
13/01/2023: The overall trial end date was changed from 30/11/2022 to 31/03/2023. Contact details updated.
02/12/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/12/2022 to 30/11/2022.
2. The intention to publish date was changed from 30/12/2022 to 31/03/2023.
04/02/2022: The overall trial end date has been changed from 31/12/2021 to 31/12/2022.
05/01/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2021 to 31/10/2021.
2. The total final enrolment number has been added.
27/11/2020: Trial's existence confirmed by Central Research Ethics Committee (CREC).
