Educational intervention for atrial fibrillation
| ISRCTN | ISRCTN93952605 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93952605 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/09/2008
- Registration date
- 18/12/2008
- Last edited
- 17/09/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Gregory Y H Lip
Scientific
Scientific
University Department of Medicine
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | TRial of an Educational intervention on patients' knowledge of Atrial fibrillation and anticoagulant therapy, international normalised ratio (INR) control, and outcome of Treatment with warfarin |
| Study acronym | TREAT |
| Study hypothesis | The recent National Institute for Health and Clinical Excellence (NICE) guidelines recommend oral anticoagulation among non-valvular atrial fibrillation (NVAF) patients at moderate to high risk of stroke. Among those eligible NVAF patients who agree to take warfarin, the following aims will be explored: 1. The primary endpoint is to examine the effects of an intensive educational intervention on patients international normalised ratio (INR) control within the therapeutic range (INR 2.0 to 3.0) 2. The secondary endpoints will determine the effects of an intensive educational intervention on patients knowledge of, and perceptions of, AF and their beliefs about anticoagulant therapy 3. In addition, the relationship between INR control and the incidence of major and minor bleeding, stroke and thromboembolic events compared to patients receiving usual care will be explored 4. Further, the reasons for persistence with anticoagulant therapy and the reasons for cessation of such treatment will be elicited 5. Finally, a health-care utilisation assessment will be undertaken to determine the costs of the intensive educational intervention compared to usual care |
| Ethics approval(s) | Black Country Research Ethics Committee, provisional approval as of 1st September 2008 (ref: 08/H1202/133). |
| Condition | Atrial fibrillation |
| Intervention | Usual care: Patients randomised to usual care will be informed about their condition and the need for anticoagulant therapy only. All patients will also receive the standard Yellow book to identify that they are taking OAC therapy. This book contains some basic information pertaining to OAC therapy. Intensive education: Those in the intensive educational intervention will attend a group session (between 6 - 8 patients for approximately 1 hour) where they will be shown a slide show of information about the need for oral anticoagulants, the risks and benefits associated with OAC therapy, potential interactions with food, drugs, and alcohol, and the importance of monitoring, and control of their INR. This presentation will be given by Professor Lip or his AF research registrar and will be interactive, where the patients are encouraged to ask questions. In addition, patients will also be given an educational booklet. All patients will be followed up for 12 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Warfarin |
| Primary outcome measure | The proportion of time spent in the therapeutic INR range, 2.0 to 3.0; all INRs recorded by the anticoagulation clinic within the first 12 months will be recorded (this will vary for each patient). |
| Secondary outcome measures | 1. Patients' knowledge and perceptions of AF, questionnaire administered at baseline (time 0), 1, 2, 6, and 12 months 2. Patients' beliefs about their medication, before and after the intervention, questionnaire administered at baseline (time 0), 1, 2, 6, and 12 months 3. The relationship between INR control and patients' experiences of warfarin treatment, the persistence of warfarin therapy, and the incidence of minor and major bleeding, stroke, and thromboembolic events (performed using ancillary analyses, given that the trial is not powered to detect these differences). The number of strokes, bleeding and thromboembolic events will be determined from the computerised clinical information system at the hospital, assessed at 1, 2, 6 and 12 months. 4. A health-economic analysis of the resource utilisation in providing an intensive educational intervention, undertaken at the end of the trial |
| Overall study start date | 01/01/2009 |
| Overall study end date | 31/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Participant inclusion criteria | 1. Atrial fibrillation patients newly referred for, and accepting of, anticoagulant therapy 2. Aged 18 years or older, either sex |
| Participant exclusion criteria | 1. Aged less than 18 years old 2. Have any contraindication to warfarin or have previously received warfarin 3. Have valvular heart disease 4. Are cognitively impaired 5. Have any disease likely to cause their death within 12 months |
| Recruitment start date | 01/01/2009 |
| Recruitment end date | 31/01/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Department of Medicine
Birmingham
B18 7QH
United Kingdom
B18 7QH
United Kingdom
Sponsor information
Bayer Plc (UK)
Industry
Industry
c/o Warren Cowell
Bayer Healthcare Pharmaceuticals
Hunton House, Highbridge Industrial Estate
Oxford Road
Uxbridge
UB8 1HU
United Kingdom
| Website | http://www.bayer.co.uk |
|---|---|
"ROR" |
https://ror.org/05emrqw14 |
Funders
Funder type
Industry
Bayer Healthcare (UK)
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- BHC
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 20/05/2010 | Yes | No | |
| Results article | results | 09/09/2013 | Yes | No |
