Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients
- Conditions
- Atrial Fibrillation
- Interventions
- Other: Care provided by AF expert program
- Registration Number
- NCT01928121
- Lead Sponsor
- Universitaire Ziekenhuizen KU 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 450
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AF expert program Care provided by AF expert program Care provided by the interdisciplinary, nurse-coordinated AF expert program
- Primary Outcome Measures
Name Time Method cardiovascular events 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
Name Time Method Guideline adherence 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)Hospitalization days and clinic visits 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 AFPerceived health After 1 year Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L)
AF related symptoms and symptom burden After 1 year AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ)
Patient satisfaction After year Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS).
Patient knowledge After 1 year The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used.
Patient adherence with medication 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).
Time to establishment of a management plan by electrophysiologist or cardiologist 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.
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Vlaams Brabant, Belgium