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

August 30, 2021 updated by: European Society of Cardiology

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: Education
Randomization between two groups at site level. One cluster with education and one without.
Other: Control arm
No added education of healthcare professionals
Behavioral: Education
Randomization between two groups at site level. One cluster with education and one without.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to ESC Guidelines in Atrial Filbrillation
Time Frame: 25 months per centre
Full adherence to guidelines for stroke prevention rhythm control therapy
25 months per centre

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of relevant guidelines adhered to
Time Frame: 25 months per centre
Proportion of relevant guidelines adhered to for stroke prevention and rhythm control
25 months per centre

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Process outcome
Time Frame: 25 months per centre
Improvement in knowledge and guideline-adherent practice by healthcare professionals using the educational intervention
25 months per centre

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Society of Cardiology

Collaborators

University of Birmingham
Soladis

Investigators

  • Study Chair: Hein Heidbuchel, Universiteit Antwerpen
  • Study Director: Dipak Kotecha, University of Birmingham
  • Study Director: Isabelle I van Gelder, University Medical Center Groningen, the Netherlands
  • Principal Investigator: 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, Institute of Cardiology, Warsaw, Poland
  • Principal Investigator: Luis Mont, University of Barcelona, Spain
  • Principal Investigator: Kim Rajappan, University of Oxford, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 15, 2021

Primary Completion (Anticipated)

September 15, 2021

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

May 14, 2020

First Submitted That Met QC Criteria

May 18, 2020

First Posted (Actual)

May 20, 2020

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STEEER-AF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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