|
ISRCTN
|
ISRCTN93952605
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Educational intervention for atrial fibrillation
|
|
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
|
|
Acronym
|
TREAT
|
|
Serial number at source
|
N/A
|
|
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
|
|
Lay summary
|
|
|
Ethics approval
|
Black Country Research Ethics Committee, provisional approval as of 1st September 2008 (ref: 08/H1202/133).
|
|
Study design
|
Multicentre randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Atrial fibrillation
|
|
Participants - inclusion criteria
|
1. Atrial fibrillation patients newly referred for, and accepting of, anticoagulant therapy
2. Aged 18 years or older, either sex
|
|
Participants - 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
|
|
Anticipated start date
|
01/01/2009
|
|
Anticipated end date
|
31/01/2011
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use the contact details below to request a patient information sheet
|
|
Target number of participants
|
200
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
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 measure(s)
|
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
|
|
Sources of funding
|
Bayer Healthcare (UK)
|
|
Trial website
|
|
|
Publications
|
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20487528
|
|
Contact name
|
Prof
Gregory Y H
Lip
|
|
Address
|
University Department of Medicine
City Hospital
Dudley Road
|
|
City/town
|
Birmingham
|
|
Zip/Postcode
|
B18 7QH
|
|
Country
|
United Kingdom
|
|
Sponsor
|
Bayer Plc (UK)
|
|
Address
|
c/o Warren Cowell
Bayer Healthcare Pharmaceuticals
Hunton House, Highbridge Industrial Estate
Oxford Road
|
|
City/town
|
Uxbridge
|
|
Zip/Postcode
|
UB8 1HU
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.bayer.co.uk
|
|
Date applied
|
24/09/2008
|
|
Last edited
|
07/12/2010
|
|
Date ISRCTN assigned
|
18/12/2008
|
