IntegRAted Chronic Care Program at a Specialized Atrial Fibrillation (AF) Clinic Versus Usual CarE in Patients With Atrial Fibrillation, an Investigator-initiated, Prospective, Randomised, Open Label, Blinded Outcome Assessment (PROBE) Controlled Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,375
- 试验地点
- 8
- 主要终点
- The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death.
研究概览
简要总结
Rationale: The treatment of patients with atrial fibrillation is often inadequate due to poor guideline adherence. An integrated chronic care program (ICCP) at a specialized AF-clinic was found to be superior to usual care provided by a cardiologist in terms of cardiovascular hospitalizations and cardiovascular mortality.
Hypothesis: treatment at a specialized AF clinic is superior to usual care in terms of cardiovascular mortality and cardiovascular hospitalizations, cost-effectiveness, quality of life and guideline adherence.
Objectives: primary objective is to show that an ICCP reduces cardiovascular hospitalizations and mortality.
Study design: randomized controlled trial with two study arms: usual care provided by cardiologists (control) versus integrated chronic care program at a specialized AF clinic (intervention) in 8 hospitals in the Netherlands. The RACE4 is an event driven study. A total number of 246 events is needed. In total 1716 patients with newly diagnosed AF will be included. Total duration of the study is 5 years and 10 months with a minimal follow up of 1 year. Data is collected at inclusion, after 3, 6, 12 months, every year thereafter and at the end of the study.
Study population: Patients older than 18 year with newly diagnosed AF.
Intervention: The intervention is delivered through the specialized outpatient AF clinic. The multidisciplinary team at the AF clinic consists of a nurse practitioner or physician assistant or specialised cardiovascular nurse, cardiologist, and is guided by guidelines-based decision support software program based on the applicable ESC guideline recommendations. The use of a web-based patient centered management of patient's own medication (Medication manager TM) was optional. A standardized diagnostic, treatment and follow-up pathway was performed within the ICCP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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 with newly diagnosed AF detected on electrocardiogram (ECG), holter recordings or event recorder with a duration > 30 seconds, 3 months before inclusion or
- •Patients with a history of diagnosed AF, with no regular control at a cardiologist for AF in the last 2 years and referred by a (non-)cardiologic medical specialist for new diagnostics or therapeutic issue;
- •Age ≥18 years.
排除标准
- •No electrocardiographic objectified AF;
- •Unstable heart failure defined as NYHA IV or heart failure necessitating hospital admission < 3 months before inclusion;
- •Acute coronary syndrome (acute myocardial infarction or instable angina pectoris, with two of the following characteristics: chest pain and/ or ischemic electrocardiographic changes, and/ or cardiac enzyme rise) < 3 months before inclusion;
- •Untreated hyperthyroidism or < 3 months euthyroidism before inclusion;
- •Foreseen pacemaker, internal cardioverter defibrillator, and/ or cardiac resynchronization therapy;
- •Cardiac surgery ≤ 3 months before inclusion;
- •Planned cardiac surgery;
- •Regular control and treatment, also for AF, at another specialized outpatient cardiac clinic;
- •Patient is not able to fill in the questionnaires;
- •Participation in other clinical study.
研究组 & 干预措施
Specialized AF-clinic
Management of AF patients in specialized outpatient AF Clinics according to the principles of an integrated chronic care program (ICCP) performed by a nurse practitioner/ physician assistant/ specialised cardiovascular nurse, cardiologist, supported by an ICT decision support tool based on professional guidelines (CardioConsult AF®). The use of a web-based patient centered management of patient's own medication (Medication manager TM) was optional. A standardized diagnostic, treatment and follow-up pathway was performed within the ICCP. In addition, the intervention is based on identifying risk factors and potential problems in patients, and addressing needs through dynamic use of personalized education and adjustment of treatment.
干预措施: Specialized outpatient AF Clinic (Other)
Usual Care
Usual care provided by cardiologists at the regular outpatient clinic.
干预措施: Usual Care (Other)
结局指标
主要结局
The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death.
时间窗: Follow up with minimum of 1 year and a maximum of 5 years and 10 months
次要结局
- All components of the primary endpoint(Follow up with minimum of 1 year and a maximum of 5 years and 10 months)
- Total number of unplanned hospitalizations related to atrial fibrillation(Follow up with minimum of 1 year and a maximum of 5 years and 10 months)
- Recurrent unplanned cardiovascular hospitalizations(Follow up with minimum of 1 year and a maximum of 5 years and 10 months)
- Costs and cost-effectiveness(baseline, 1 year, 2 years, 3 years)
- Patient Quality of life(Baseline, 1 year, 2 years, 3 years)
- Knowledge of AF(Baseline, 1 year, 2 years, 3 years)
- All-cause mortality(Minimum of 1 year and a maximum of 5 years and 10 months)
- Duration of unplanned cardiovascular hospitalizations(Follow up with minimum of 1 year and a maximum of 5 years and 10 months)
- Duration of unplanned hospitalizations related to atrial fibrillation(Follow up with minimum of 1 year and a maximum of 5 years and 10 months)
- Implementation of care(Follow up with minimum of 1 year and a maximum of 5 years and 10 months)
- Total number of unplanned all-cause hospitalizations(Follow up with minimum of 1 year and a maximum of 5 years and 10 months)
- Duration of unplanned all-cause hospitalizations(Follow up with minimum of 1 year and a maximum of 5 years and 10 months)
- Total number of unplanned cardiovascular hospitalizations(Follow up with minimum of 1 year and a maximum of 5 years and 10 months)
- Anxiety and/ or depression(Baseline, 1 year, 2 years, 3 years)
- Compliance to medication(Baseline, 1 year, 2 years, 3 years)