Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients
1 other identifier
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable atrial-fibrillation
Started Sep 2013
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2013
CompletedFirst Posted
Study publicly available on registry
August 23, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedAugust 26, 2013
August 1, 2013
2.9 years
August 19, 2013
August 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Guideline adherence
after 1 year
Hospitalization days and clinic visits
after 1 year
Perceived health
After 1 year
AF related symptoms and symptom burden
After 1 year
Patient satisfaction
After year
- +3 more secondary outcomes
Study Arms (2)
AF expert program
EXPERIMENTALCare provided by the interdisciplinary, nurse-coordinated AF expert program
Usual care
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Every newly diagnosed AF patient.
- AF must be confirmed on electrocardiogram.
- Capable of providing written informed consent.
- Dutch speaking and verbally testable, without cognitive impairment.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, Vlaams Brabant, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Hein Heidbuchel, MD, PHD
Study Record Dates
First Submitted
August 19, 2013
First Posted
August 23, 2013
Study Start
September 1, 2013
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
August 26, 2013
Record last verified: 2013-08