Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients - A Clustered Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- cardiovascular events
研究概览
简要总结
The purpose of this study is to assess the effectiveness of a newly developed interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a prospective, pragmatic clustered randomized controlled trial will be performed in general practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Every newly diagnosed AF patient.
- •Every AF patient who is not seen by a cardiologist or electrophysiologist in the past 2 years before inclusion.
- •AF must be confirmed on electrocardiogram.
- •Capable of providing written informed consent.
- •Dutch speaking and verbally testable, without cognitive impairment.
排除标准
- •AF patients who once received an arrhythmologic consult about AF prior to the start of the study.
- •AF patients who have a systematic follow-up at a cardiologist prior to the start of the study.
- •Terminally ill AF patients
- •Participation in another clinical trial
研究组 & 干预措施
AF expert program
Care provided by the interdisciplinary, nurse-coordinated AF expert program
干预措施: Care provided by AF expert program (Other)
Usual care
结局指标
主要结局
cardiovascular events
时间窗: after 1 year
Combined endpoint of cardiovascular hospitalizations, cardiovascular deaths and unplanned cardiovascular visits. * Cardiac death: Cardiac arrhythmic, Cardiac non-arrhythmic, Vascular non cardiac * Cardiovascular hospitalization: Arrhythmic events (AF, syncope, sustained ventricular tachycardia, cardiac arrest), Heart Failure, Acute myocardial infarction, Stroke, Systemic embolism, Major bleeding, Life-threatening effects of drugs * Unplanned cardiovascular visits
次要结局
- Guideline adherence(after 1 year)
- Hospitalization days and clinic visits(after 1 year)
- Perceived health(After 1 year)
- AF related symptoms and symptom burden(After 1 year)
- Patient satisfaction(After year)
- Patient knowledge(After 1 year)
- Patient adherence with medication(After 1 year)
- Time to establishment of a management plan by electrophysiologist or cardiologist(After 1 year)
研究者
Prof Heidbuchel
Prof. Hein Heidbuchel, MD, PHD
Universitaire Ziekenhuizen KU Leuven