Stroke Prevention and Rhythm Control Therapy STEEER-AF

European Society of Cardiology

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Behavioral: Education

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT04396418

STEEER-AF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,732 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,732 participants in 2 patient groups

Intervention arm

Experimental group

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

Treatment:

Behavioral: Education

Control arm

Other group

Description:

No added education of healthcare professionals

Treatment:

Behavioral: Education