Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Guideline adherence, stroke prevention, rhythm control, trial
Brief summary
A prospective trial with hospitals/health centres across 6 different European countries, being randomised to either a structured education programme as the intervention or no additional education as the control. To determine whether a comprehensive educational programme for healthcare professionals will increase the rate of appropriate stroke prevention and rhythm control therapy in patients with atrial fibrillation (AF) and adherence to Guidelines.
Detailed description
Prospective, parallel group, two-arm, unblinded, international, cluster-randomized controlled trial. Intervention arm: A 16-week blended learning programme targeting stroke prevention and rhythm control therapy at the healthcare professional level, with controlled assessments, a commitment to change plan, and reinforcement actions Control arm: No added education of healthcare professionals 70 centres with a cluster size of 25 patients; total estimated number of patients 1750. 8-12 weeks patient recruitment period at each centre; 16 weeks educational intervention period; primary & secondary outcomes at 6-9 months post-randomisation; remote follow-up for clinical events (no new patient contact) at 18 months from randomisation.
Interventions
BEHAVIORALEducation
Randomization between two groups at site level. One cluster with education and one without.
Sponsors
University of Birmingham
European Society of Cardiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with AF * Patient consents to data collection at baseline and follow-up.
Exclusion criteria
(patients only): * Patients aged under 18 years of age, * Pregnant or planning pregnancy, * Participating in another clinical trial of an investigational medicinal product or device, * Life expectancy of less than 2 years. Patient assessment: Baseline (time of recruitment) and at follow-up routine appointment (6-9 months), plus remote follow-up at 18 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to ESC Guidelines in Atrial Filbrillation | 25 months per centre | Full adherence to guidelines for stroke prevention rhythm control therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of relevant guidelines adhered to | 25 months per centre | Proportion of relevant guidelines adhered to for stroke prevention and rhythm control |
Other
| Measure | Time frame | Description |
|---|---|---|
| Process outcome | 25 months per centre | Improvement in knowledge and guideline-adherent practice by healthcare professionals using the educational intervention |
Countries
France, Germany, Italy, Poland, Spain, United Kingdom
Outcome results
None listed