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IntegRAted CarE for Atrial Fibrillation - RACE-4 (RACE-4)

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ClinicalTrials.gov Identifier: NCT01740037
Recruitment Status : Active, not recruiting
First Posted : December 4, 2012
Last Update Posted : January 1, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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. 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 8 hospitals in the Netherlands. The RACE4 is an event driven study. A total number of 246 events is needed. In total 1375 patients with newly diagnosed AF are 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
Atrial Fibrillation Other: Specialized AF Clinic Other: Usual Care

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : December 2012
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Patient quality of life [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
  4. 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 ]
  5. Patients' knowledge of AF [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]
  6. Patients' compliance in medication [ Time Frame: Participants will be followed with minimum follow up of 1 year and maximum follow up of 6 years ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with newly diagnosed AF detected on electrocardiogram (ECG), holter recordings or event recorder with a duration > 30 seconds, 3 months before inclusion or
  2. 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;
  3. Age ≥18 years.

Exclusion Criteria:

  1. No electrocardiographic objectified AF;
  2. Unstable heart failure defined as NYHA IV or heart failure necessitating hospital admission < 3 months before inclusion;
  3. 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;
  4. Untreated hyperthyroidism or < 3 months euthyroidism before inclusion;
  5. Foreseen pacemaker, internal cardioverter defibrillator, and/ or cardiac resynchronization therapy;
  6. Cardiac surgery ≤ 3 months before inclusion;
  7. Planned cardiac surgery;
  8. Regular control and treatment, also for AF, at another specialized outpatient cardiac clinic;
  9. Patient is not able to fill in the questionnaires;
  10. Participation in other clinical study.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01740037


Locations
Netherlands
Martini Ziekenhuis
Groningen, Netherlands
UMCG
Groningen, Netherlands
Spaarne Gasthuis
Haarlem, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
MUMC+
Maastricht, Netherlands
Canisius Wilhelmina Ziekenhuis Nijmegen
Nijmegen, Netherlands
Zaans Medisch Centrum
Zaandam, Netherlands
Isala
Zwolle, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Stichting Achmea Gezondheidszor
DSW
CZ Fonds
Bayer
Boehringer Ingelheim
Bristol-Myers Squibb
Pfizer
Daiichi Sankyo, Inc.
Investigators
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
More Information

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01740037     History of Changes
Other Study ID Numbers: METC 11-2-099
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: January 1, 2018
Last Verified: December 2017

Keywords provided by Maastricht University Medical Center:
Chronic care program
Nurse specialist
Atrial Fibrillation guideline

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes