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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04396418
Other study ID # STEEER-AF
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 29, 2021
Est. completion date December 30, 2025

Study information

Verified date June 2024
Source European Society of Cardiology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 1732
Est. completion date December 30, 2025
Est. primary completion date January 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Education
Randomization between two groups at site level. One cluster with education and one without.

Locations

Country Name City State
France CHU Aix en Provence Aix en Provence Provence-Alpes-Côte d'Azur
France Hôpital Henri Mondor (APHP) Créteil Île-de-France
France CHU Dijon - Hôpital du Bocage Dijon Burgundy
France CHU Dupuytren Limoges Haute-Vienne
France CHU La Timone Marseille Bouches-du-Rhône
France CHU Nancy, Hôpitaux de Brabois Nancy Meurthe-et-Moselle (Lorraine)
France CHU Pitié-Salpetrière Paris Ile De France
France Centre Hospitalier de Pau Pau Pyrénées-Atlantiques
France Hôpital Cardiologique du Haut-Lévèque Pessac Gironde, Nouvelle-Aquitaine
France CHU Poitiers Poitiers Poitou-Charentes
France CHU Rennes Rennes 'Ille-et-Vilaine, Brittany
France CHU Rouen Rouen Normandy
France Centre Cardiologique du Nord (CCN) Saint-Denis Ile De France
France CHI Toulon La Seyne-sur-Mer Sainte Musse Toulon Var
France CHU Rangueil Toulouse Occitanie, Haute-Garonne
Germany Segeberger Kliniken GmbH Bad Segeberg chleswig-Holstein
Germany Praxisklinik Herz Und Gefässe Dresden Saxony
Germany Asklepios Klinik St. Georg Hamburg
Germany Heart Center University Hamburg Hamburg
Germany Medizinische Hochschule Hannover, MHH Hannover
Germany Herzzentrum Niederrhein Krefeld Krefeld North Rhine-Westphalia
Germany Heart Center Leipzig, University of Leipzig Leipzig Saxony
Germany Universitätsklinikum Schleswig-Holstein Lübeck Lübeck
Germany Heart Centre Bad Neustadt Neustadt Rhineland-Palatinate
Germany Herz Riesa Riesa Saxony
Germany University Hospital Würzburg Würzburg Bavaria
Italy Clinica Aritmologica, Universita Politecnica delle Marche Ancona
Italy S Orsola-Malpighi University Hospital Bologna Emilia-Romagna
Italy Sant'Anna University Hospital of Ferrara Ferrara Emilia-Romagna
Italy Cardiology Unit Borgo San Lorenzo and Serristori Florence
Italy University of Florence & AOU Careggi Florence Tuscany
Italy Policlinico di Modena, University of Modena and Reggio Emilia Modena Emilia-Romagna
Italy Federico II University Hospital Naples Campania
Italy Cardiologia Orvieto Orvieto Terni
Poland District Chojnice Hospital Chojnice
Poland Scanmed Cardiology Center Elk
Poland Centrum Opieki Medycznej w Jaroslawiu Jaroslaw
Poland Poliklinika SPZOZ w Lublinie Lublin
Poland Lukow Lukow
Poland Przasnysz Przasnysz
Poland Pultusk Pultusk
Poland Siedlce 2 Hospital Siedlce
Poland Wojewódzki Szpital Specjalistyczny nr 5 im Sosnowiec
Poland Szpital Wojewodzki in Sw. Lukasza / Regional Specialist Hospital Tarnow
Poland Torun Hospital Torun Vistula Rive
Poland Wegrow Hospital Wegrow
Spain Hospital General Universitario de Alicante Alicante Valencian
Spain Hospital Germans Trias i Pujol Barcelona Catalonia
Spain Hospital Universitari de Bellvitge Barcelona Catalonia
Spain Hospital Vall d'Hebron Barcelona Catalonia
Spain Hospital Universitari Doctor Josep Trueta Girona Catalonia
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Puerta del Mar Sevilla Andalusia
Spain Virgen del Rocio University Hospital Sevilla Andalucía
Spain Hospital La Fe.com.Valencianna Valencia
Spain Hospital Gral Vigo, Galicia Vigo
Spain Hospital Miguel Servet Zaragoza Aragon
United Kingdom Horton General Hospital Banbury River Cherwell In Oxfordshire
United Kingdom Queen Elizabeth II Birmingham
United Kingdom Buckinghamshire Healthcare NHS Trust - Wycombe Hospital Buckingham Buckinghamshire
United Kingdom Royal Devon and Exeter NHS Foundation Trust Exeter West England
United Kingdom Gloucestershire Royal Hospital Gloucester England
United Kingdom Homerton Hospital London England
United Kingdom Imperial College London Chelsea and Westminster Hospital NHS foundation London England
United Kingdom St Bartholomew's Hospital London England
United Kingdom James Cook University Hospital Middlesborough England
United Kingdom Northampton General Hospital Northampton England
United Kingdom Norwich Hospital Norwich East Of England
United Kingdom Royal Berkshire foundation NHS trust Reading England
United Kingdom York Hospital York North Yorkshire

Sponsors (2)

Lead Sponsor Collaborator
European Society of Cardiology University of Birmingham

Countries where clinical trial is conducted

France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Process outcome Improvement in knowledge and guideline-adherent practice by healthcare professionals using the educational intervention 25 months per centre
Primary Adherence to ESC Guidelines in Atrial Filbrillation Full adherence to guidelines for stroke prevention rhythm control therapy 25 months per centre
Secondary Proportion of relevant guidelines adhered to Proportion of relevant guidelines adhered to for stroke prevention and rhythm control 25 months per centre
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