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

Atrial Fibrillation Clinical Trial

Official title:

Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients - A Clustered Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01928121
• Other study ID #: not yet applicable
• Status: Not yet recruiting
• Phase: N/A
• First received: August 19, 2013
• Last updated: August 23, 2013
• Start date: September 2013
• Est. completion date: August 2016

Study information

• Verified date: August 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Dana Berti
• Phone: 0032-479-845016
• Email: dana.berti[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: UZ Leuven Medical Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Care provided by AF expert program

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	after 1 year	No
Secondary	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)	after 1 year	No
Secondary	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	after 1 year	No
Secondary	Perceived health	Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L)	After 1 year	No
Secondary	AF related symptoms and symptom burden	AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ)	After 1 year	No
Secondary	Patient satisfaction	Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS).	After year	No
Secondary	Patient knowledge	The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used.	After 1 year	No
Secondary	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).	After 1 year	No
Secondary	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.	After 1 year	No