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Stroke Prevention and Rhythm Control Therapy STEEER-AF (STEEER-AF)

Primary Purpose

Atrial Fibrillation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Education
Sponsored by
European Society of Cardiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Intervention arm

    Control arm

    Arm Description

    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

    No added education of healthcare professionals

    Outcomes

    Primary Outcome Measures

    Adherence to ESC Guidelines in Atrial Filbrillation
    Full adherence to guidelines for stroke prevention rhythm control therapy

    Secondary Outcome Measures

    Proportion of relevant guidelines adhered to
    Proportion of relevant guidelines adhered to for stroke prevention and rhythm control

    Full Information

    First Posted
    May 14, 2020
    Last Updated
    August 30, 2021
    Sponsor
    European Society of Cardiology
    Collaborators
    Soladis, University of Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04396418
    Brief Title
    Stroke Prevention and Rhythm Control Therapy STEEER-AF
    Acronym
    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

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2021 (Anticipated)
    Primary Completion Date
    September 15, 2021 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    European Society of Cardiology
    Collaborators
    Soladis, University of Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Atrial Fibrillation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    1750 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention arm
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control arm
    Arm Type
    Other
    Arm Description
    No added education of healthcare professionals
    Intervention Type
    Behavioral
    Intervention Name(s)
    Education
    Intervention Description
    Randomization between two groups at site level. One cluster with education and one without.
    Primary Outcome Measure Information:
    Title
    Adherence to ESC Guidelines in Atrial Filbrillation
    Description
    Full adherence to guidelines for stroke prevention rhythm control therapy
    Time Frame
    25 months per centre
    Secondary Outcome Measure Information:
    Title
    Proportion of relevant guidelines adhered to
    Description
    Proportion of relevant guidelines adhered to for stroke prevention and rhythm control
    Time Frame
    25 months per centre
    Other Pre-specified Outcome Measures:
    Title
    Process outcome
    Description
    Improvement in knowledge and guideline-adherent practice by healthcare professionals using the educational intervention
    Time Frame
    25 months per centre

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Céline Arsac
    Phone
    0033489872075
    Email
    carsac@escardio.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Patti-Ann M McNeill
    Phone
    0033492948637
    Email
    pmcneill@escardio.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hein Heidbuchel
    Organizational Affiliation
    Universiteit Antwerpen
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Dipak Kotecha
    Organizational Affiliation
    University of Birmingham
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Isabelle I van Gelder
    Organizational Affiliation
    University Medical Center Groningen, The Netherlands
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Serge Boveda
    Organizational Affiliation
    Clinique Pasteur, France
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Philipp Sommer
    Organizational Affiliation
    Ruhr-Universität Bochum, Germany
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Giuseppe Boriani
    Organizational Affiliation
    University of Modena & Reggio Emilia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Maciej Sterliński
    Organizational Affiliation
    National Institute of Cardiology, Warsaw, Poland
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Luis Mont
    Organizational Affiliation
    University of Barcelona, Spain
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kim Rajappan
    Organizational Affiliation
    University of Oxford, UK
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34969173
    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. Erratum In: Eur J Heart Fail. 2022 Sep;24(9):1739.
    Results Reference
    derived

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    Stroke Prevention and Rhythm Control Therapy STEEER-AF

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