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IntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4 (RACE4)

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ClinicalTrials.gov Identifier: NCT01740037
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : May 28, 2019
Sponsor:
Collaborators:
Stichting Achmea Gezondheidszor
DSW
CZ Fonds
Bayer
Boehringer Ingelheim
Bristol-Myers Squibb
Pfizer
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Maastricht University Medical Center

Tracking Information
First Submitted Date  ICMJE October 16, 2012
First Posted Date  ICMJE December 4, 2012
Last Update Posted Date May 28, 2019
Actual Study Start Date  ICMJE December 2012
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
The primary endpoint is a composite of unplanned admission to the hospital for any cardiovascular reason and cardiovascular death. [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
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 ]
The endpoint events associated with hospitalisation or death are
  1. Left or right ventricular heart failure which is independent of left ventricular ejection fraction (LVEF) and requiring intravenous diuretics;
  2. Ischemic thromboembolic complications including stroke, peripheral, pulmonary or systemic emboli (confirmed by a neurologist on the basis of computerised tomography or MRI);
  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);
  4. Bleeding (a bleeding with the hemoglobin value decreased by > 20 g/ L (>2g/ dL) or requiring blood transfusion
  5. Arrhythmic or potential arrhythmic events (atrial fibrillation, -flutter, other supraventricular rhythm or sustained ventricular tachycardia confirmed by ECG, syncope or cardiac arrest)
  6. Life-threatening adverse effects of rate or rhythm controlling drugs
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • All components of the primary endpoint [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  • All-cause mortality [ Time Frame: Minimum of 1 year and a maximum of 5 years and 10 months ]
  • Total number of unplanned all-cause hospitalizations [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  • Duration of unplanned all-cause hospitalizations [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  • Total number of unplanned cardiovascular hospitalizations [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  • Duration of unplanned cardiovascular hospitalizations [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  • Total number of unplanned hospitalizations related to atrial fibrillation [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  • Duration of unplanned hospitalizations related to atrial fibrillation [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  • Recurrent unplanned cardiovascular hospitalizations [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  • Costs and cost-effectiveness [ Time Frame: baseline, 1 year, 2 years, 3 years ]
    Costs, Quality Adjusted Life Years (QALYs) and Cost-effectiveness (Incremental Cost-Effectiveness Ratio - ICER)
  • Implementation of care [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
    The extent to which the comprehensive cardiovascular treatment is in accordance with the most recent ESC guidelines Management of Atrial Fibrillation, the HF guidelines of acute and chronic heart failure and the CVD prevention guidelines
  • Patient Quality of life [ Time Frame: Baseline, 1 year, 2 years, 3 years ]
    General health-related QoL is measured by using the SF-36
  • Patient Quality of life [ Time Frame: Baseline, 1 year, 2 years, 3 years ]
    Patient's perception of severity of arrhythmia-related symptoms is measured by using the AFSS
  • Anxiety and/ or depression [ Time Frame: Baseline, 1 year, 2 years, 3 years ]
    HADS-NL
  • Knowledge of AF [ Time Frame: Baseline, 1 year, 2 years, 3 years ]
    Netherlands Knowledge Scale on AF
  • Compliance to medication [ Time Frame: Baseline, 1 year, 2 years, 3 years ]
    MMAS
  • Compliance to medication [ Time Frame: Baseline, 1 year, 2 years, 3 years ]
    To measure the level of activation of a specific individual the PAM-13 Dutch is used
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2012)
  • Costs and cost benefit of the intervention by means of a cost effectiveness analysis [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ]
  • 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 at yearly intervals, an expected average of 2.4 years ]
  • Patient quality of life [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ]
  • Patient anxiety and/ or depression [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ]
  • Patients' knowledge of AF [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ]
  • Patients' compliance in medication [ Time Frame: Participants will be followed at yearly intervals, an expected average of 2.4 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IntegRAted Chronic Care Program at Specialized AF Clinic Versus Usual CarE in Patients With Atrial Fibrillation - RACE4
Official Title  ICMJE 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Other: Specialized outpatient AF Clinic
  • Other: Usual Care
Study Arms  ICMJE
  • Experimental: Specialized AF-clinic
    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.
    Intervention: Other: Specialized outpatient AF Clinic
  • Active Comparator: Usual Care
    Usual care provided by cardiologists at the regular outpatient clinic.
    Intervention: Other: Usual Care
Publications * Wijtvliet EPJP, Tieleman RG, van Gelder IC, Pluymaekers NAHA, Rienstra M, Folkeringa RJ, Bronzwaer P, Elvan A, Elders J, Tukkie R, Luermans JGLM, Van Asselt ADIT, Van Kuijk SMJ, Tijssen JG, Crijns HJGM; RACE 4 Investigators. Nurse-led vs. usual-care for atrial fibrillation. Eur Heart J. 2020 Feb 1;41(5):634-641. doi: 10.1093/eurheartj/ehz666.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 29, 2017)
1375
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2012)
1716
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01740037
Other Study ID Numbers  ICMJE METC 11-2-099
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Maastricht University Medical Center
Study Sponsor  ICMJE Maastricht University Medical Center
Collaborators  ICMJE
  • Stichting Achmea Gezondheidszor
  • DSW
  • CZ Fonds
  • Bayer
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Pfizer
  • Daiichi Sankyo, Inc.
Investigators  ICMJE
Principal Investigator: H.J.G.M. Crijns, prof. dr. Maastricht University Medical Center
Principal Investigator: I.C. Van Gelder, prof. dr. UMCG
Principal Investigator: R.G. Tieleman, dr. Martini Ziekenhuis
PRS Account Maastricht University Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP