IntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4 (RACE4)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Integrated chronic care program, specialized outpatient AF clinic, Atrial Fibrillation guideline
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Martini Ziekenhuis
- UMCG
- Spaarne Gasthuis
- Medisch Centrum Leeuwarden
- MUMC+
- Canisius Wilhelmina Ziekenhuis Nijmegen
- Zaans Medisch Centrum
- Isala
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Specialized AF-clinic
Usual Care
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.
Usual care provided by cardiologists at the regular outpatient clinic.