Stroke Prevention and Rhythm Control Therapy STEEER-AF
- Conditions
- Atrial Fibrillation
- Interventions
- Behavioral: Education
- Registration Number
- NCT04396418
- Lead Sponsor
- European Society of Cardiology
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1732
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control arm Education No added education of healthcare professionals Intervention arm Education 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
- Primary Outcome Measures
Name Time Method Adherence to ESC Guidelines in Atrial Filbrillation 25 months per centre Full adherence to guidelines for stroke prevention rhythm control therapy
- Secondary Outcome Measures
Name Time Method Proportion of relevant guidelines adhered to 25 months per centre Proportion of relevant guidelines adhered to for stroke prevention and rhythm control
Trial Locations
- Locations (70)
St Bartholomew's Hospital
🇬🇧London, England, United Kingdom
Szpital Wojewodzki in Sw. Lukasza / Regional Specialist Hospital
🇵🇱Tarnow, Poland
Homerton Hospital
🇬🇧London, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesborough, England, United Kingdom
University Hospital Würzburg
🇩🇪Würzburg, Bavaria, Germany
Scanmed Cardiology Center
🇵🇱Ełk, Poland
York Hospital
🇬🇧York, North Yorkshire, United Kingdom
CHU Rangueil
🇫🇷Toulouse, Occitanie, Haute-Garonne, France
CHU Rouen
🇫🇷Rouen, Normandy, France
CHU Poitiers
🇫🇷Poitiers, Poitou-Charentes, France
Federico II University Hospital
🇮🇹Naples, Campania, Italy
Segeberger Kliniken GmbH
🇩🇪Bad Segeberg, chleswig-Holstein, Germany
CHU Aix en Provence
🇫🇷Aix en Provence, Provence-Alpes-Côte d'Azur, France
CHU La Timone
🇫🇷Marseille, Bouches-du-Rhône, France
CHU Dupuytren
🇫🇷Limoges, Haute-Vienne, France
Universitätsklinikum Schleswig-Holstein Lübeck
🇩🇪Lübeck, Germany
Cardiology Unit Borgo San Lorenzo and Serristori
🇮🇹Florence, Italy
CHU Nancy, Hôpitaux de Brabois
🇫🇷Nancy, Meurthe-et-Moselle (Lorraine), France
Heart Center University Hamburg
🇩🇪Hamburg, Germany
Hospital Universitario Puerta del Mar
🇪🇸Sevilla, Andalusia, Spain
University of Florence & AOU Careggi
🇮🇹Florence, Tuscany, Italy
Hôpital Henri Mondor (APHP)
🇫🇷Créteil, Île-de-France, France
Hospital Gral Vigo, Galicia
🇪🇸Vigo, Spain
Lukow
🇵🇱Lukow, Poland
Wojewódzki Szpital Specjalistyczny nr 5 im
🇵🇱Sosnowiec, Poland
Clinica Aritmologica, Universita Politecnica delle Marche
🇮🇹Ancona, Italy
S Orsola-Malpighi University Hospital
🇮🇹Bologna, Emilia-Romagna, Italy
Siedlce 2 Hospital
🇵🇱Siedlce, Poland
Hospital General Universitario de Alicante
🇪🇸Alicante, Valencian, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Miguel Servet
🇪🇸Zaragoza, Aragon, Spain
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Catalonia, Spain
Norwich Hospital
🇬🇧Norwich, East Of England, United Kingdom
Hospital La Fe.com.Valencianna
🇪🇸Valencia, Spain
Gloucestershire Royal Hospital
🇬🇧Gloucester, England, United Kingdom
Queen Elizabeth II
🇬🇧Birmingham, United Kingdom
Royal Berkshire foundation NHS trust
🇬🇧Reading, England, United Kingdom
Horton General Hospital
🇬🇧Banbury, River Cherwell In Oxfordshire, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
🇬🇧Exeter, West England, United Kingdom
Hospital Vall d'Hebron
🇪🇸Barcelona, Catalonia, Spain
Buckinghamshire Healthcare NHS Trust - Wycombe Hospital
🇬🇧Buckingham, Buckinghamshire, United Kingdom
CHU Dijon - Hôpital du Bocage
🇫🇷Dijon, Burgundy, France
CHU Rennes
🇫🇷Rennes, 'Ille-et-Vilaine, Brittany, France
Hôpital Cardiologique du Haut-Lévèque
🇫🇷Pessac, Gironde, Nouvelle-Aquitaine, France
CHU Pitié-Salpetrière
🇫🇷Paris, Ile De France, France
Centre Cardiologique du Nord (CCN)
🇫🇷Saint-Denis, Ile De France, France
Asklepios Klinik St. Georg
🇩🇪Hamburg, Germany
Medizinische Hochschule Hannover, MHH
🇩🇪Hannover, Germany
Praxisklinik Herz Und Gefässe
🇩🇪Dresden, Saxony, Germany
Herzzentrum Niederrhein Krefeld
🇩🇪Krefeld, North Rhine-Westphalia, Germany
Sant'Anna University Hospital of Ferrara
🇮🇹Ferrara, Emilia-Romagna, Italy
Policlinico di Modena, University of Modena and Reggio Emilia
🇮🇹Modena, Emilia-Romagna, Italy
Centrum Opieki Medycznej w Jaroslawiu
🇵🇱Jaroslaw, Poland
Toruń Hospital
🇵🇱Toruń, Vistula Rive, Poland
Virgen del Rocio University Hospital
🇪🇸Sevilla, AndalucÃa, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Catalonia, Spain
Hospital Universitari Doctor Josep Trueta
🇪🇸Girona, Catalonia, Spain
PoliklinikÄ… SPZOZ w Lublinie
🇵🇱Lublin, Poland
Przasnysz
🇵🇱Przasnysz, Poland
Pułtusk
🇵🇱Pułtusk, Poland
Wegrow Hospital
🇵🇱Wegrow, Poland
Centre Hospitalier de Pau
🇫🇷Pau, Pyrénées-Atlantiques, France
CHI Toulon La Seyne-sur-Mer Sainte Musse
🇫🇷Toulon, Var, France
Cardiologia Orvieto
🇮🇹Orvieto, Terni, Italy
District Chojnice Hospital
🇵🇱Chojnice, Poland
Heart Center Leipzig, University of Leipzig
🇩🇪Leipzig, Saxony, Germany
Heart Centre Bad Neustadt
🇩🇪Neustadt, Rhineland-Palatinate, Germany
Herz Riesa
🇩🇪Riesa, Saxony, Germany
Northampton General Hospital
🇬🇧Northampton, England, United Kingdom
Imperial College London Chelsea and Westminster Hospital NHS foundation
🇬🇧London, England, United Kingdom