Stroke Prevention and Rhythm Control Therapy STEEER-AF
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
Behavioral: Education
Randomization between two groups at site level. One cluster with education and one without.
|
| Other: Control arm No added education of healthcare professionals |
Behavioral: Education
Randomization between two groups at site level. One cluster with education and one without.
|
Outcome Measures
Primary Outcome Measures
- Adherence to ESC Guidelines in Atrial Filbrillation [25 months per centre]
Full adherence to guidelines for stroke prevention rhythm control therapy
Secondary Outcome Measures
- Proportion of relevant guidelines adhered to [25 months per centre]
Proportion of relevant guidelines adhered to for stroke prevention and rhythm control
Other Outcome Measures
- Process outcome [25 months per centre]
Improvement in knowledge and guideline-adherent practice by healthcare professionals using the educational intervention
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- European Society of Cardiology
- Soladis
- University of Birmingham
Investigators
- Study Chair: Hein Heidbuchel, Universiteit Antwerpen
- Study Director: Dipak Kotecha, University of Birmingham
- Study Director: Isabelle I van Gelder, University Medical Center Groningen, The Netherlands
- Principal Investigator: Serge Boveda, Clinique Pasteur, France
- Principal Investigator: Philipp Sommer, Ruhr-Universität Bochum, Germany
- Principal Investigator: Giuseppe Boriani, University of Modena & Reggio Emilia
- Principal Investigator: Maciej Sterliński, Institute of Cardiology, Warsaw, Poland
- Principal Investigator: Luis Mont, University of Barcelona, Spain
- Principal Investigator: Kim Rajappan, University of Oxford, UK
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STEEER-AF