Stroke Prevention and Rhythm Control Therapy STEEER-AF

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stroke Prevention and Rhythm Control Therapy: Evaluation of an Educational Programme of the European Society of Cardiology in a Cluster-Randomised Trial in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>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 | Behavioral: Education<br>* Randomization between two groups at site level. One cluster with education and one without.<br>|
| Other: Control arm<br>No added education of healthcare professionals | Behavioral: Education<br>* Randomization between two groups at site level. One cluster with education and one without.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to ESC Guidelines in Atrial Filbrillation | Full adherence to guidelines for stroke prevention rhythm control therapy | 25 months per centre | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of relevant guidelines adhered to | Proportion of relevant guidelines adhered to for stroke prevention and rhythm control | 25 months per centre |