IntegRAted CarE for Atrial Fibrillation - RACE-4 (RACE-4)
|ClinicalTrials.gov Identifier: NCT01740037|
Recruitment Status : Active, not recruiting
First Posted : December 4, 2012
Last Update Posted : January 24, 2018
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 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 6 years with a minimal follow up of 1 year and maximum of 6 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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Other: Specialized AF Clinic Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1375 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
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|
- Primary endpoint is a composite, defined as unplanned admission to the hospital for any cardiovascular reason and cardiovascular death. [ Time Frame: Participants will be followed at yearly intervals, minimum follow up of 1 year and maximum follow up of 6 years ]
- Costs and cost benefit of the intervention by means of a cost effectiveness analysis [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
- The extent to which the comprehensive cardiovascular treatment is in accordance to the latest European Society of Cardiology (ESC) AF guidelines, the ESC Heart Failure guidelines and the ESC Cardiovascular Disease Prevention guidelines [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
- Patient quality of life [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
- Patient anxiety and/ or depression [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
- Patients' knowledge of AF [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
- Patients' compliance in medication [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740037
|Medisch Centrum Leeuwarden|
|Canisius Wilhelmina Ziekenhuis Nijmegen|
|Zaans Medisch Centrum|
|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|