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Educational intervention for atrial fibrillation

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN93952605
Enrollment
200
Registered
2008-12-18
Start date
2009-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation Circulatory System Atrial fibrillation and flutter

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 th

Sponsors

Bayer Plc (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Atrial fibrillation patients newly referred for, and accepting of, anticoagulant therapy 2. Aged 18 years or older, either sex

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 31, 2026