Educational intervention for atrial fibrillatio

Completed

Conditions: Atrial fibrillation
Circulatory System
Atrial fibrillation and flutter

Registration Number: ISRCTN93952605

Lead Sponsor: Bayer Plc (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
1. Patients' knowledge and perceptions of AF, questionnaire administered at baseline (time 0), 1, 2, 6, and 12 months<br>2. Patients' beliefs about their medication, before and after the intervention, questionnaire administered at baseline (time 0), 1, 2, 6, and 12 months<br>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.<br>4. A health-economic analysis of the resource utilisation in providing an intensive educational intervention, undertaken at the end of the trial