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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,732
- 试验地点
- 137
- 主要终点
- Adherence to ESC Guidelines in Atrial Filbrillation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Adherence to ESC Guidelines in Atrial Filbrillation
时间窗: 25 months per centre
Full adherence to guidelines for stroke prevention rhythm control therapy
次要结局
- Proportion of relevant guidelines adhered to(25 months per centre)