Stroke Prevention and Rhythm Control Therapy STEEER-AF

NCT ID: NCT04396418

Last Updated: 2024-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

1732 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-29

Study Completion Date

2025-12-30

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Education

Intervention Type BEHAVIORAL

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

Control arm

No added education of healthcare professionals

Group Type OTHER

Education

Intervention Type BEHAVIORAL

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

Interventions

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Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Birmingham

OTHER

Sponsor Role collaborator

European Society of Cardiology

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hein Heidbuchel

Role: STUDY_CHAIR

Universiteit Antwerpen

Dipak Kotecha

Role: STUDY_DIRECTOR

University of Birmingham

Isabelle van Gelder

Role: STUDY_DIRECTOR

University Medical Center Groningen, The Netherlands

Serge Boveda

Role: PRINCIPAL_INVESTIGATOR

Clinique Pasteur, France

Philipp Sommer

Role: PRINCIPAL_INVESTIGATOR

Ruhr-Universität Bochum, Germany

Giuseppe Boriani

Role: PRINCIPAL_INVESTIGATOR

University of Modena & Reggio Emilia

Maciej Sterliński

Role: PRINCIPAL_INVESTIGATOR

National Institute of Cardiology, Warsaw, Poland

Luis Mont

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona, Spain

Kim Rajappan

Role: PRINCIPAL_INVESTIGATOR

University of Oxford, UK

Eduard Guasch

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona, Spain

Locations

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CHU Rennes

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

Site Status

CHU La Timone

Marseille, Bouches-du-Rhône, France

Site Status

CHU Dijon - Hôpital du Bocage

Dijon, Burgundy, France

Site Status

Hôpital Cardiologique du Haut-Lévèque

Pessac, Gironde, Nouvelle-Aquitaine, France

Site Status

CHU Dupuytren

Limoges, Haute-Vienne, France

Site Status

CHU Nancy, Hôpitaux de Brabois

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

Site Status

CHU Rouen

Rouen, Normandy, France

Site Status

CHU Rangueil

Toulouse, Occitanie, Haute-Garonne, France

Site Status

CHU Poitiers

Poitiers, Poitou-Charentes, France

Site Status

CHU Aix en Provence

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

Site Status

Centre Hospitalier de Pau

Pau, Pyrénées-Atlantiques, France

Site Status

CHI Toulon La Seyne-sur-Mer Sainte Musse

Toulon, Var, France

Site Status

Hôpital Henri Mondor (APHP)

Créteil, Île-de-France Region, France

Site Status

CHU Pitié-Salpetrière

Paris, Île-de-France Region, France

Site Status

Centre Cardiologique du Nord (CCN)

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

Site Status

University Hospital Würzburg

Würzburg, Bavaria, Germany

Site Status

Segeberger Kliniken GmbH

Bad Segeberg, chleswig-Holstein, Germany

Site Status

Herzzentrum Niederrhein Krefeld

Krefeld, North Rhine-Westphalia, Germany

Site Status

Heart Centre Bad Neustadt

Neustadt, Rhineland-Palatinate, Germany

Site Status

Praxisklinik Herz Und Gefässe

Dresden, Saxony, Germany

Site Status

Heart Center Leipzig, University of Leipzig

Leipzig, Saxony, Germany

Site Status

Herz Riesa

Riesa, Saxony, Germany

Site Status

Asklepios Klinik St. Georg

Hamburg, , Germany

Site Status

Heart Center University Hamburg

Hamburg, , Germany

Site Status

Medizinische Hochschule Hannover, MHH

Hanover, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein Lübeck

Lübeck, , Germany

Site Status

Federico II University Hospital

Naples, Campania, Italy

Site Status

S Orsola-Malpighi University Hospital

Bologna, Emilia-Romagna, Italy

Site Status

Sant'Anna University Hospital of Ferrara

Ferrara, Emilia-Romagna, Italy

Site Status

Policlinico di Modena, University of Modena and Reggio Emilia

Modena, Emilia-Romagna, Italy

Site Status

Cardiologia Orvieto

Orvieto, Terni, Italy

Site Status

University of Florence & AOU Careggi

Florence, Tuscany, Italy

Site Status

Clinica Aritmologica, Universita Politecnica delle Marche

Ancona, , Italy

Site Status

Cardiology Unit Borgo San Lorenzo and Serristori

Florence, , Italy

Site Status

Toruń Hospital

Torun, Vistula Rive, Poland

Site Status

District Chojnice Hospital

Chojnice, , Poland

Site Status

Scanmed Cardiology Center

Ełk, , Poland

Site Status

Centrum Opieki Medycznej w Jaroslawiu

Jarosław, , Poland

Site Status

Polikliniką SPZOZ w Lublinie

Lublin, , Poland

Site Status

Przasnysz

Przasnysz, , Poland

Site Status

Pułtusk

Pułtusk, , Poland

Site Status

Siedlce 2 Hospital

Siedlce, , Poland

Site Status

Wojewódzki Szpital Specjalistyczny nr 5 im

Sosnowiec, , Poland

Site Status

Szpital Wojewodzki in Sw. Lukasza / Regional Specialist Hospital

Tarnów, , Poland

Site Status

Wegrow Hospital

Węgrów, , Poland

Site Status

Lukow

Łuków, , Poland

Site Status

Hospital Universitario Puerta del Mar

Seville, Andalusia, Spain

Site Status

Virgen del Rocio University Hospital

Seville, Andalusia, Spain

Site Status

Hospital Miguel Servet

Zaragoza, Aragon, Spain

Site Status

Hospital Vall d'Hebron

Barcelona, Catalonia, Spain

Site Status

Hospital Universitari de Bellvitge

Barcelona, Catalonia, Spain

Site Status

Hospital Germans Trias i Pujol

Barcelona, Catalonia, Spain

Site Status

Hospital Universitari Doctor Josep Trueta

Girona, Catalonia, Spain

Site Status

Hospital General Universitario de Alicante

Alicante, Valencian, Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital La Fe.com.Valencianna

Valencia, , Spain

Site Status

Hospital Gral Vigo, Galicia

Vigo, , Spain

Site Status

Buckinghamshire Healthcare NHS Trust - Wycombe Hospital

Buckingham, Buckinghamshire, United Kingdom

Site Status

Norwich Hospital

Norwich, East of England, United Kingdom

Site Status

Gloucestershire Royal Hospital

Gloucester, England, United Kingdom

Site Status

Homerton Hospital

London, England, United Kingdom

Site Status

St Bartholomew's Hospital

London, England, United Kingdom

Site Status

Imperial College London Chelsea and Westminster Hospital NHS foundation

London, England, United Kingdom

Site Status

James Cook University Hospital

Middlesbrough, England, United Kingdom

Site Status

Northampton General Hospital

Northampton, England, United Kingdom

Site Status

Royal Berkshire foundation NHS trust

Reading, England, United Kingdom

Site Status

York Hospital

York, North Yorkshire, United Kingdom

Site Status

Horton General Hospital

Banbury, River Cherwell in Oxfordshire, United Kingdom

Site Status

Royal Devon and Exeter NHS Foundation Trust

Exeter, West England, United Kingdom

Site Status

Queen Elizabeth II

Birmingham, , United Kingdom

Site Status

Countries

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France Germany Italy Poland Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 40514462 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38940494 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36746430 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34969173 (View on PubMed)

Other Identifiers

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STEEER-AF

Identifier Type: -

Identifier Source: org_study_id

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