Educational intervention for atrial fibrillation

ISRCTN	ISRCTN93952605
DOI	https://doi.org/10.1186/ISRCTN93952605
Protocol serial number	N/A
Sponsor	Bayer Plc (UK)
Funder	Bayer Healthcare (UK)

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 of protocol

Not provided at time of registration

Contact information

Prof Gregory Y H Lip
Scientific

University Department of Medicine
City Hospital
Dudley Road
Birmingham
B18 7QH
United Kingdom

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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).
Health condition(s) or problem(s) studied	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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Warfarin
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).
Key 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
Completion date	31/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	200
Key inclusion criteria	1. Atrial fibrillation patients newly referred for, and accepting of, anticoagulant therapy 2. Aged 18 years or older, either sex
Key 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
Date of first enrolment	01/01/2009
Date of final enrolment	31/01/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University Department of Medicine

Birmingham
B18 7QH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	09/09/2013		Yes	No
Protocol article	protocol	20/05/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes