IntegRAted CarE for Atrial Fibrillation - RACE-4
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. The secondary objectives include cost-effectiveness, guideline adherence, quality of life, patient knowledge and patient compliance in medication.
Study design: randomized controlled trial with two study arms: usual care provided by cardiologists (control) versus ICCP at a specialized AF-clinic (intervention) in 9 hospitals in the Netherlands. In total 1716 patients with newly diagnosed AF will be included. Total duration of the study is 4,5 years and total mean follow-up will be 2,4 years. Data collected at inclusion, after 3, 6, 12 months and every year thereafter.
Study population: Patients older than 18 year with newly diagnosed AF.
Intervention: treatment through an ICCP at specialized AF clinics, consisting of a nurse specialist, cardiologist-supervisor and a guidelines-based information-communication technology (ICT) decision support program and a web-based patient centered medication management tool and tailored telemonitoring.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||IntegRAted Chronic Care Program at a Specialized Atrial Fibrillation (AF) Clinic Versus Usual CarE in Patients With Atrial Fibrillation, a Multicenter Randomized Controlled Clinical Trial|
- Primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death. [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ] [ Designated as safety issue: No ]
The endpoint events associated with hospitalisation or death are
- Left or right ventricular heart failure which is independent of left ventricular ejection fraction (LVEF) and requiring intravenous diuretics;
- Ischemic thromboembolic complications including stroke, peripheral, pulmonary or systemic emboli (confirmed by a neurologist on the basis of computerised tomography or MRI);
- 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);
- Bleeding (a bleeding with the hemoglobin value decreased by > 20 g/ L (>2g/ dL) or requiring blood transfusion
- Arrhythmic or potential arrhythmic events (atrial fibrillation, -flutter, other supraventricular rhythm or sustained ventricular tachycardia confirmed by ECG, syncope or cardiac arrest)
- Life-threatening adverse effects of rate or rhythm controlling drugs
- Costs and cost benefit of the intervention by means of a cost effectiveness analysis [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
- The extent to which the comprehensive cardiovascular treatment is in accordance to the 2010 European Society of Cardiology (ESC) AF guidelines, the 2008 ESC Heart Failure guidelines and the 2007 ESC Cardiovascular Disease Prevention guidelines [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
- Patient quality of life [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
- Patient anxiety and/ or depression [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
- Patients' knowledge of AF [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
- Patients' compliance in medication [ Time Frame: Participants will be followed an expected average of 2.4 years ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Specialized AF-clinic
Management of AF patients in specialized AF Clinics according to the principles of an integrated chronic care program (ICCP) performed by nurse specialists, supported by an ICT decision support tool based on professional guidelines (CardioConsult AF®) and supervised by a cardiologist. In addition, a web-based patient centered medication management tool (Medication Manager(TM)and tailored telemonitoring at an outpatient AF clinic. 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.
|Other: Specialized AF Clinic|
Active Comparator: Usual Care
Usual care provided by cardiologists at the regular outpatient clinic.
|Other: Usual Care|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01740037
|Contact: H.J.G.M. Crijns, prof. email@example.com|
|Contact: E.P.J. Wijtvliet, MSc||0031(0)firstname.lastname@example.org|
|Contact: R.G. Tieleman, MD, PhD +31505446245|
|Principal Investigator: R.G. Tieleman, dr.|
|Contact: I. C. Van Gelder, MD, PhD +31503611327|
|Principal Investigator: I. C. Van Gelder, prof. dr.|
|Contact: B Van Vlies, dr. +31235453545|
|Principal Investigator: B. Van Vlies, dr.|
|Medisch Centrum Leeuwarden||Recruiting|
|Contact: J.R. Folkeringa, drs. +31582861214|
|Principal Investigator: J.R. Folkeringa, drs.|
|Contact: H. J. Crijns, MD, PhD +31433875093|
|Principal Investigator: H. J. Crijns, prof. dr.|
|Canisius Wilhelmina Ziekenhuis Nijmegen||Recruiting|
|Contact: L.H.R. Bouwels, drs. +31243658782|
|Principal Investigator: L.H.R. Bouwels, drs.|
|Zaans Medisch Centrum||Recruiting|
|Contact: P.N.A. Bronzwaer, dr. +31756502911|
|Principal Investigator: P.N.A. Bronzwaer, dr.|
|Contact: A. Elvan, dr. 0031(0)38 - 4244273 email@example.com|
|Principal Investigator: A. Elvan, dr.|
|Principal Investigator:||H.J.G.M. Crijns, prof. dr.||MUMC+|
|Principal Investigator:||I.C. Van Gelder, prof. dr.||UMCG|
|Principal Investigator:||R.G. Tieleman, dr.||Martini Ziekenhuis|