An interventional study of Care provided by AF expert program in Atrial Fibrillation, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-08-26.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Health services research
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 923 are open to participants now.
This study's planned enrollment of 450 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Care provided by the interdisciplinary, nurse-coordinated AF expert program
Other: Care provided by AF expert program
cardiovascular events
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
Time frame: after 1 year
Guideline adherence
* 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)
Time frame: after 1 year
Hospitalization days and clinic visits
* 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
Time frame: after 1 year
Perceived health
Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L)
Time frame: After 1 year
AF related symptoms and symptom burden
AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ)
Time frame: After 1 year
Patient satisfaction
Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS).
Time frame: After year
Patient knowledge
The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used.
Time frame: After 1 year
Patient adherence with medication
This will be assessed by self-report using the Dutch version of the 8-item Morisky Medication Adherence Scale (MMAS-8 scale).
Time frame: After 1 year
Time to establishment of a management plan by electrophysiologist or cardiologist
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.
Time frame: After 1 year
This study is status unknown, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Universitaire Ziekenhuizen KU Leuven