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Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01928121
Recruitment Status : Unknown
Verified August 2013 by Prof Heidbuchel, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Not yet recruiting
First Posted : August 23, 2013
Last Update Posted : August 26, 2013
Sponsor:
Information provided by (Responsible Party):
Prof Heidbuchel, Universitaire Ziekenhuizen Leuven

Brief Summary:
The purpose of this study is to assess the effectiveness of a newly developed interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a prospective, pragmatic clustered randomized controlled trial will be performed in general practices.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Care provided by AF expert program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients - A Clustered Randomized Controlled Trial
Study Start Date : September 2013
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AF expert program
Care provided by the interdisciplinary, nurse-coordinated AF expert program
Other: Care provided by AF expert program
No Intervention: Usual care



Primary Outcome Measures :
  1. cardiovascular events [ Time Frame: after 1 year ]

    Combined endpoint of cardiovascular hospitalizations, cardiovascular deaths and unplanned cardiovascular visits.

    • Cardiac death: Cardiac arrhythmic, Cardiac non-arrhythmic, Vascular non cardiac
    • Cardiovascular hospitalization: Arrhythmic events (AF, syncope, sustained ventricular tachycardia, cardiac arrest), Heart Failure, Acute myocardial infarction, Stroke, Systemic embolism, Major bleeding, Life-threatening effects of drugs
    • Unplanned cardiovascular visits


Secondary Outcome Measures :
  1. Guideline adherence [ Time Frame: after 1 year ]
    • Does the medical record report a formal CHA2DS2-VASc score, HAS-BLED bleeding risk score and EHRA score?
    • Does the medical record report an appropriate prescription of antithrombotic treatment.
    • Does the medical record report an appropriate application of rate and rhythm (not if asymptomatic, if contraindicated and not in patients with permanent AF)
    • Does the medical record report an appropriate upstream therapy? (For example in heart failure patients, is the heart failure treated)

  2. Hospitalization days and clinic visits [ Time Frame: after 1 year ]
    • Number of outpatient (internal or neurological) clinic visits per year
    • Number of emergency room visits per year due to AF
    • Number of hospitalization days due to AF
    • Number of hospitalization days for cardiovascular reasons
    • Number of hospitalization days on intensive care due to AF

  3. Perceived health [ Time Frame: After 1 year ]
    Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L)

  4. AF related symptoms and symptom burden [ Time Frame: After 1 year ]
    AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ)

  5. Patient satisfaction [ Time Frame: After year ]
    Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS).

  6. Patient knowledge [ Time Frame: After 1 year ]
    The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used.

  7. Patient adherence with medication [ Time Frame: After 1 year ]
    This will be assessed by self-report using the Dutch version of the 8-item Morisky Medication Adherence Scale (MMAS-8 scale).

  8. Time to establishment of a management plan by electrophysiologist or cardiologist [ Time Frame: After 1 year ]
    This outcome will be searched for by reviewing medical records of, or by interviewing, all participating patients at 1, 3, 6 months and 1 year.



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:

  • Every newly diagnosed AF patient.
  • Every AF patient who is not seen by a cardiologist or electrophysiologist in the past 2 years before inclusion.
  • AF must be confirmed on electrocardiogram.
  • Capable of providing written informed consent.
  • Dutch speaking and verbally testable, without cognitive impairment.

Exclusion Criteria:

  • AF patients who once received an arrhythmologic consult about AF prior to the start of the study.
  • AF patients who have a systematic follow-up at a cardiologist prior to the start of the study.
  • Terminally ill AF patients
  • Participation in another clinical trial

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): NCT01928121


Contacts
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Contact: Dana Berti 0032-479-845016 dana.berti@uzleuven.be
Contact: Hein Heidbuchel 0032-16-344248 hein.heidbuchel@uzleuven.be

Locations
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Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Contact: Dana Berti    0032-16-341848    dana.berti@uzleuven.be   
Contact: Hein Heidbuchel    0032-16-344248    hein.heidbuchel@uzleuven.be   
Sub-Investigator: Dana Berti         
Principal Investigator: Hein Heidbuchel         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Responsible Party: Prof Heidbuchel, Prof. Hein Heidbuchel, MD, PHD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01928121    
Other Study ID Numbers: not yet applicable
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2013
Keywords provided by Prof Heidbuchel, Universitaire Ziekenhuizen Leuven:
nurse
expert program
primary care
implementation
interdisciplinary
effectiveness
disease management system
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes