Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 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
Brief Summary: 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.


Options:
A: Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Nurse-coordinated integrated care model for AF | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Nurse-coordinated integrated care model for AF; Assigned to Arm(s): Intervention group
B: Arm Label: Specialized AF-clinic; Type: EXPERIMENTAL; Interventions: Other: Specialized outpatient AF Clinic | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual Care | Intervention Type: OTHER; Name: Specialized outpatient AF Clinic; Assigned to Arm(s): Specialized AF-clinic | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Usual Care
C: Arm Label: AF Clinic; Type: EXPERIMENTAL; Interventions: Other: AF Clinic | Arm Label: Care as Usual; Type: ACTIVE_COMPARATOR; Interventions: Other: Care as Usual | Intervention Type: OTHER; Name: AF Clinic; Assigned to Arm(s): AF Clinic | Intervention Type: OTHER; Name: Care as Usual; Assigned to Arm(s): Care as Usual
D: Arm Label: Arm 1; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Weekly patient self-testing of prothrombin time | Arm Label: Arm 2; Type: OTHER; Interventions: Other: High quality anticoagulation management (HQACM) with conventional monthly testing | Intervention Type: PROCEDURE; Name: Weekly patient self-testing of prothrombin time; Assigned to Arm(s): Arm 1 | Intervention Type: OTHER; Name: High quality anticoagulation management (HQACM) with conventional monthly testing; Assigned to Arm(s): Arm 2

Answer: B