Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-15 @ 1:22 AM
Study NCT ID:
NCT04396418
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2020-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stroke Prevention and Rhythm Control Therapy STEEER-AF
Sponsor:
European Society of Cardiology
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEEER-AF
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: