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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

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Specialized outpatient AF Clinic Other: Usual Care Not Applicable

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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, an Investigator-initiated, Prospective, Randomised, Open Label, Blinded Outcome Assessment (PROBE) Controlled Multi-center Study
Actual Study Start Date : December 2012
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Specialized outpatient AF Clinic
Active Comparator: Usual Care
Usual care provided by cardiologists at the regular outpatient clinic.
Other: Usual Care



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. All components of the primary endpoint [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  2. All-cause mortality [ Time Frame: Minimum of 1 year and a maximum of 5 years and 10 months ]
  3. 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 ]
  4. Duration of unplanned all-cause hospitalizations [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  5. Total number of unplanned cardiovascular hospitalizations [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  6. Duration of unplanned cardiovascular hospitalizations [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  7. 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 ]
  8. 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 ]
  9. Recurrent unplanned cardiovascular hospitalizations [ Time Frame: Follow up with minimum of 1 year and a maximum of 5 years and 10 months ]
  10. 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)

  11. 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

  12. Patient Quality of life [ Time Frame: Baseline, 1 year, 2 years, 3 years ]
    General health-related QoL is measured by using the SF-36

  13. 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

  14. Anxiety and/ or depression [ Time Frame: Baseline, 1 year, 2 years, 3 years ]
    HADS-NL

  15. Knowledge of AF [ Time Frame: Baseline, 1 year, 2 years, 3 years ]
    Netherlands Knowledge Scale on AF

  16. Compliance to medication [ Time Frame: Baseline, 1 year, 2 years, 3 years ]
    MMAS

  17. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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
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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
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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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01740037    
Other Study ID Numbers: METC 11-2-099
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: May 28, 2019
Last Verified: April 2019
Keywords provided by Maastricht University Medical Center:
Integrated chronic care program
specialized outpatient AF clinic
Atrial Fibrillation guideline
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes