NCT04396418

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.

Trial Health

62
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,732

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
6 countries

70 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
1.6 years until next milestone

Study Start

First participant enrolled

December 29, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 20, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

May 14, 2020

Last Update Submit

June 18, 2024

Conditions

Keywords

Atrial fibrillationGuideline adherencestroke preventionrhythm controltrial

Outcome Measures

Primary Outcomes (1)

  • Adherence to ESC Guidelines in Atrial Filbrillation

    Full adherence to guidelines for stroke prevention rhythm control therapy

    25 months per centre

Secondary Outcomes (1)

  • Proportion of relevant guidelines adhered to

    25 months per centre

Other Outcomes (1)

  • Process outcome

    25 months per centre

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

OTHER

No added education of healthcare professionals

Behavioral: Education

Interventions

EducationBEHAVIORAL

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

Control armIntervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with AF
  • Patient consents to data collection at baseline and follow-up.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (70)

CHU Rennes

Rennes, 'Ille-et-Vilaine, Brittany, 35000, France

Location

CHU La Timone

Marseille, Bouches-du-Rhône, 13005, France

Location

CHU Dijon - Hôpital du Bocage

Dijon, Burgundy, 21000, France

Location

Hôpital Cardiologique du Haut-Lévèque

Pessac, Gironde, Nouvelle-Aquitaine, 33600, France

Location

CHU Dupuytren

Limoges, Haute-Vienne, 87000, France

Location

CHU Nancy, Hôpitaux de Brabois

Nancy, Meurthe-et-Moselle (Lorraine), 54500, France

Location

CHU Rouen

Rouen, Normandy, 76000, France

Location

CHU Rangueil

Toulouse, Occitanie, Haute-Garonne, 31400, France

Location

CHU Poitiers

Poitiers, Poitou-Charentes, 86000, France

Location

CHU Aix en Provence

Aix-en-Provence, Provence-Alpes-Côte d'Azur Region, 13100, France

Location

Centre Hospitalier de Pau

Pau, Pyrénées-Atlantiques, 64046, France

Location

CHI Toulon La Seyne-sur-Mer Sainte Musse

Toulon, Var, 83100, France

Location

Hôpital Henri Mondor (APHP)

Créteil, Île-de-France Region, 94000, France

Location

CHU Pitié-Salpetrière

Paris, Île-de-France Region, 75013, France

Location

Centre Cardiologique du Nord (CCN)

Saint-Denis, Île-de-France Region, 93200, France

Location

University Hospital Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, chleswig-Holstein, 23795, Germany

Location

Herzzentrum Niederrhein Krefeld

Krefeld, North Rhine-Westphalia, 47805, Germany

Location

Heart Centre Bad Neustadt

Neustadt, Rhineland-Palatinate, 97616, Germany

Location

Praxisklinik Herz Und Gefässe

Dresden, Saxony, 01099, Germany

Location

Heart Center Leipzig, University of Leipzig

Leipzig, Saxony, 04289, Germany

Location

Herz Riesa

Riesa, Saxony, 01587, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Heart Center University Hamburg

Hamburg, 20251, Germany

Location

Medizinische Hochschule Hannover, MHH

Hanover, 30159, Germany

Location

Universitätsklinikum Schleswig-Holstein Lübeck

Lübeck, 23562, Germany

Location

Federico II University Hospital

Naples, Campania, 80138, Italy

Location

S Orsola-Malpighi University Hospital

Bologna, Emilia-Romagna, 40138, Italy

Location

Sant'Anna University Hospital of Ferrara

Ferrara, Emilia-Romagna, 44100, Italy

Location

Policlinico di Modena, University of Modena and Reggio Emilia

Modena, Emilia-Romagna, 41100, Italy

Location

Cardiologia Orvieto

Orvieto, Terni, 05018, Italy

Location

University of Florence & AOU Careggi

Florence, Tuscany, 50121, Italy

Location

Clinica Aritmologica, Universita Politecnica delle Marche

Ancona, 60100, Italy

Location

Cardiology Unit Borgo San Lorenzo and Serristori

Florence, Italy

Location

Toruń Hospital

Torun, Vistula Rive, 87-100, Poland

Location

District Chojnice Hospital

Chojnice, 89-600, Poland

Location

Scanmed Cardiology Center

Ełk, 19-302., Poland

Location

Centrum Opieki Medycznej w Jaroslawiu

Jarosław, 37-500, Poland

Location

Polikliniką SPZOZ w Lublinie

Lublin, 20-400, Poland

Location

Przasnysz

Przasnysz, 06-300, Poland

Location

Pułtusk

Pułtusk, 06-100, Poland

Location

Siedlce 2 Hospital

Siedlce, 08-119, Poland

Location

Wojewódzki Szpital Specjalistyczny nr 5 im

Sosnowiec, 41-200, Poland

Location

Szpital Wojewodzki in Sw. Lukasza / Regional Specialist Hospital

Tarnów, 33-100, Poland

Location

Wegrow Hospital

Węgrów, 07-100, Poland

Location

Lukow

Łuków, 21-400, Poland

Location

Hospital Universitario Puerta del Mar

Seville, Andalusia, 11009, Spain

Location

Virgen del Rocio University Hospital

Seville, Andalusia, 41013, Spain

Location

Hospital Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

Hospital Vall d'Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Catalonia, 08907, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Catalonia, 08916, Spain

Location

Hospital Universitari Doctor Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Hospital General Universitario de Alicante

Alicante, Valencian, 03010, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital La Fe.com.Valencianna

Valencia, 46026, Spain

Location

Hospital Gral Vigo, Galicia

Vigo, Spain

Location

Buckinghamshire Healthcare NHS Trust - Wycombe Hospital

Buckingham, Buckinghamshire, HP11 2TT, United Kingdom

Location

Norwich Hospital

Norwich, East of England, NR1-NR16, United Kingdom

Location

Gloucestershire Royal Hospital

Gloucester, England, GL1 3NN, United Kingdom

Location

Homerton Hospital

London, England, E9 6SR, United Kingdom

Location

St Bartholomew's Hospital

London, England, EC1A 7BE, United Kingdom

Location

Imperial College London Chelsea and Westminster Hospital NHS foundation

London, England, SW10 9NH, United Kingdom

Location

James Cook University Hospital

Middlesbrough, England, TS4 3BW, United Kingdom

Location

Northampton General Hospital

Northampton, England, NN1 5BD, United Kingdom

Location

Royal Berkshire foundation NHS trust

Reading, England, RG1 5AN, United Kingdom

Location

York Hospital

York, North Yorkshire, YO31 8H, United Kingdom

Location

Horton General Hospital

Banbury, River Cherwell in Oxfordshire, OX16, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, West England, 01392, United Kingdom

Location

Queen Elizabeth II

Birmingham, United Kingdom

Location

Related Publications (4)

  • Kotecha D, Bunting KV, Mehta S, Sommer P, Sterlinski M, Rajappan K, Mont L, Guasch E, Boveda S, Boriani G, Sun Y, van Deutekom C, Gale CP, De Potter TJR, van Gelder IC; STEEER-AF investigators. Education of healthcare professionals to improve guideline adherence in atrial fibrillation: the STEEER-AF cluster-randomized clinical trial. Nat Med. 2025 Aug;31(8):2647-2654. doi: 10.1038/s41591-025-03751-2. Epub 2025 Jun 13.

  • Sterlinski M, Bunting KV, Boriani G, Boveda S, Guasch E, Mont L, Rajappan K, Sommer P, Mehta S, Sun Y, Gale CP, van Deutekom C, Van Gelder IC, Kotecha D; STEEER-AF Trial Team. Design and deployment of the STEEER-AF trial to evaluate and improve guideline adherence: a cluster-randomized trial by the European Society of Cardiology and European Heart Rhythm Association. Europace. 2024 Jul 2;26(7):euae178. doi: 10.1093/europace/euae178.

  • Szymanski P, Weidinger F, Lordereau-Richard I, Himmelmann A, Arca M, Chaves J, Lee C, Jonker C, Kotecha D, O'Kelly J, Plueschke K, Rys A, Segec A, Wallentin L, Veltrop R, James S. Real world evidence: Perspectives from a European Society of Cardiology Cardiovascular Round Table with contribution from the European Medicines Agency. Eur Heart J Qual Care Clin Outcomes. 2023 Feb 28;9(2):109-118. doi: 10.1093/ehjqcco/qcad009.

  • 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.

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Hein Heidbuchel

    Universiteit Antwerpen

    STUDY CHAIR
  • Dipak Kotecha

    University of Birmingham

    STUDY DIRECTOR
  • Isabelle van Gelder

    University Medical Center Groningen, The Netherlands

    STUDY DIRECTOR
  • 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

    National Institute of Cardiology, Warsaw, Poland

    PRINCIPAL INVESTIGATOR
  • Luis Mont

    University of Barcelona, Spain

    PRINCIPAL INVESTIGATOR
  • Kim Rajappan

    University of Oxford, UK

    PRINCIPAL INVESTIGATOR
  • Eduard Guasch

    University of Barcelona, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2020

First Posted

May 20, 2020

Study Start

December 29, 2021

Primary Completion

January 10, 2024

Study Completion

December 30, 2025

Last Updated

June 20, 2024

Record last verified: 2024-06

Locations