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

Not Applicable

• Conditions: Atrial Fibrillation

• 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

Study Timeline

• Status Verified: 2013-08
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-23
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26
• Study Start: 2013-09
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 AF
Perceived 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