Clinical trial NCT04396418: Stroke Prevention and Rhythm Control Therapy STEEER-AF
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Guideline adherence
stroke prevention
rhythm control
trial
Lead sponsor: European Society of Cardiology
Sponsor class: NETWORK
Collaborators: name: University of Birmingham
First posted: 2020-05-20
Enrollment: 1732
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Adherence to ESC Guidelines in Atrial Filbrillation
timeFrame: 25 months per centre
Secondary outcomes:
measure: Proportion of relevant guidelines adhered to
timeFrame: 25 months per centre
Other outcomes:
measure: Process outcome
timeFrame: 25 months per centre
Locations:
city: Rennes
country: France
facility: CHU Rennes
state: 'Ille-et-Vilaine, Brittany
city: Marseille
country: France
facility: CHU La Timone
state: Bouches-du-Rhône
city: Dijon
country: France
facility: CHU Dijon - Hôpital du Bocage
state: Burgundy
city: Pessac
country: France
facility: Hôpital Cardiologique du Haut-Lévèque
state: Gironde, Nouvelle-Aquitaine
city: Limoges
country: France
facility: CHU Dupuytren
state: Haute-Vienne
city: Paris
country: France
facility: CHU Pitié-Salpetrière
state: Ile De France
city: Saint-Denis
country: France
facility: Centre Cardiologique du Nord (CCN)
state: Ile De France
city: Nancy
country: France
facility: CHU Nancy, Hôpitaux de Brabois
state: Meurthe-et-Moselle (Lorraine)
city: Rouen
country: France
facility: CHU Rouen
state: Normandy
city: Toulouse
country: France
facility: CHU Rangueil
state: Occitanie, Haute-Garonne
city: Poitiers
country: France
facility: CHU Poitiers
state: Poitou-Charentes
city: Aix en Provence
country: France
facility: CHU Aix en Provence
state: Provence-Alpes-Côte d'Azur
city: Pau
country: France
facility: Centre Hospitalier de Pau
state: Pyrénées-Atlantiques
city: Toulon
country: France
facility: CHI Toulon La Seyne-sur-Mer Sainte Musse
state: Var
city: Créteil
country: France
facility: Hôpital Henri Mondor (APHP)
state: Île-de-France
city: Würzburg
country: Germany
facility: University Hospital Würzburg
state: Bavaria
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
state: chleswig-Holstein
city: Krefeld
country: Germany
facility: Herzzentrum Niederrhein Krefeld
state: North Rhine-Westphalia
city: Neustadt
country: Germany
facility: Heart Centre Bad Neustadt
state: Rhineland-Palatinate
city: Dresden
country: Germany
facility: Praxisklinik Herz Und Gefässe
state: Saxony
city: Leipzig
country: Germany
facility: Heart Center Leipzig, University of Leipzig
state: Saxony
city: Riesa
country: Germany
facility: Herz Riesa
state: Saxony
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Heart Center University Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, MHH
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Lübeck
city: Naples
country: Italy
facility: Federico II University Hospital
state: Campania
city: Bologna
country: Italy
facility: S Orsola-Malpighi University Hospital
state: Emilia-Romagna
city: Ferrara
country: Italy
facility: Sant'Anna University Hospital of Ferrara
state: Emilia-Romagna
city: Modena
country: Italy
facility: Policlinico di Modena, University of Modena and Reggio Emilia
state: Emilia-Romagna
city: Orvieto
country: Italy
facility: Cardiologia Orvieto
state: Terni
city: Florence
country: Italy
facility: University of Florence & AOU Careggi
state: Tuscany
city: Ancona
country: Italy
facility: Clinica Aritmologica, Universita Politecnica delle Marche
city: Florence
country: Italy
facility: Cardiology Unit Borgo San Lorenzo and Serristori
city: Toruń
country: Poland
facility: Toruń Hospital
state: Vistula Rive
city: Chojnice
country: Poland
facility: District Chojnice Hospital
city: Ełk
country: Poland
facility: Scanmed Cardiology Center
city: Jaroslaw
country: Poland
facility: Centrum Opieki Medycznej w Jaroslawiu
city: Lublin
country: Poland
facility: Polikliniką SPZOZ w Lublinie
city: Lukow
country: Poland
facility: Lukow
city: Przasnysz
country: Poland
facility: Przasnysz
city: Pułtusk
country: Poland
facility: Pułtusk
city: Siedlce
country: Poland
facility: Siedlce 2 Hospital
city: Sosnowiec
country: Poland
facility: Wojewódzki Szpital Specjalistyczny nr 5 im
city: Tarnow
country: Poland
facility: Szpital Wojewodzki in Sw. Lukasza / Regional Specialist Hospital
city: Wegrow
country: Poland
facility: Wegrow Hospital
city: Sevilla
country: Spain
facility: Virgen del Rocio University Hospital
state: Andalucía
city: Sevilla
country: Spain
facility: Hospital Universitario Puerta del Mar
state: Andalusia
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
state: Aragon
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Catalonia
city: Girona
country: Spain
facility: Hospital Universitari Doctor Josep Trueta
state: Catalonia
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
state: Valencian
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Valencia
country: Spain
facility: Hospital La Fe.com.Valencianna
city: Vigo
country: Spain
facility: Hospital Gral Vigo, Galicia
city: Buckingham
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust - Wycombe Hospital
state: Buckinghamshire
city: Norwich
country: United Kingdom
facility: Norwich Hospital
state: East Of England
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital
state: England
city: London
country: United Kingdom
facility: Homerton Hospital
state: England
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
state: England
city: London
country: United Kingdom
facility: Imperial College London Chelsea and Westminster Hospital NHS foundation
state: England
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital
state: England
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
state: England
city: Reading
country: United Kingdom
facility: Royal Berkshire foundation NHS trust
state: England
city: York
country: United Kingdom
facility: York Hospital
state: North Yorkshire
city: Banbury
country: United Kingdom
facility: Horton General Hospital
state: River Cherwell In Oxfordshire
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
state: West England
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth II
Study officials:
affiliation: Universiteit Antwerpen
name: Hein Heidbuchel
role: STUDY_CHAIR
affiliation: University of Birmingham
name: Dipak Kotecha
role: STUDY_DIRECTOR
affiliation: University Medical Center Groningen, The Netherlands
name: Isabelle van Gelder
role: STUDY_DIRECTOR
affiliation: Clinique Pasteur, France
name: Serge Boveda
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruhr-Universität Bochum, Germany
name: Philipp Sommer
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Modena & Reggio Emilia
name: Giuseppe Boriani
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Maciej Sterliński
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona, Spain
name: Luis Mont
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford, UK
name: Kim Rajappan
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Barcelona, Spain
name: Eduard Guasch
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banerjee A, Pasea L, Chung SC, Direk K, Asselbergs FW, Grobbee DE, Kotecha D, Anker SD, Dyszynski T, Tyl B, Denaxas S, Lumbers RT, Hemingway H. A population-based study of 92 clinically recognized risk factors for heart failure: co-occurrence, prognosis and preventive potential. Eur J Heart Fail. 2022 Mar;24(3):466-480. doi: 10.1002/ejhf.2417. Epub 2022 Jan 26.