Trials / Active Not Recruiting
Active Not RecruitingNCT04396418
Stroke Prevention and Rhythm Control Therapy STEEER-AF
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,732 (actual)
- Sponsor
- European Society of Cardiology · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Education | Randomization between two groups at site level. One cluster with education and one without. |
Timeline
- Start date
- 2021-12-29
- Primary completion
- 2024-01-10
- Completion
- 2025-12-30
- First posted
- 2020-05-20
- Last updated
- 2024-06-20
Locations
70 sites across 6 countries: France, Germany, Italy, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT04396418. Inclusion in this directory is not an endorsement.