Clinical trial NCT00753259: Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation.
Official title: The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
disease management program
integrated chronic care program
guideline
stroke
heart failure
quality of life
costs
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-09-16
Enrollment: 712
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Randomized controlled trial comparing specialized AF Clinic with 'care as usual'
* Hypothesis: treatment of AF patients in the AF-Clinic by a nurse, specialised in AF, using guideline-based dedicated software, under supervision of a cardiologist, is efficient, safe and not inferior to care as usual by a cardiologists.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed atrial fibrillation

Exclusion Criteria:

* Age \< 18 years
* unwillingness to participate

Primary outcomes:
measure: Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes.
timeFrame: minimum of 1 year
Secondary outcomes:
measure: All cause mortality, all cause hospitalizations, Treatment (benchmarking) in accordance to the 2006 AHA/ACC/ESC guidelines in AF, quality of life, patient satisfaction, anxiety, depression, compliance and cost effectiveness.
timeFrame: minimum of 1 year
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Martini Hospital Groningen
city: Maastricht
country: Netherlands
facility: MaastrichtUMC
Study officials:
affiliation: Maastricht UMC
name: Robert G Tieleman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hendriks JM, Vrijhoef HJ, Crijns HJ, Brunner-La Rocca HP. The effect of a nurse-led integrated chronic care approach on quality of life in patients with atrial fibrillation. Europace. 2014 Apr;16(4):491-9. doi: 10.1093/europace/eut286. Epub 2013 Sep 20.
citation: Hendriks JM, Crijns HJ, Tieleman RG, Vrijhoef HJ. The atrial fibrillation knowledge scale: development, validation and results. Int J Cardiol. 2013 Sep 30;168(2):1422-8. doi: 10.1016/j.ijcard.2012.12.047. Epub 2013 Jan 8.
citation: Hendriks JM, de Wit R, Crijns HJ, Vrijhoef HJ, Prins MH, Pisters R, Pison LA, Blaauw Y, Tieleman RG. Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. Eur Heart J. 2012 Nov;33(21):2692-9. doi: 10.1093/eurheartj/ehs071. Epub 2012 Mar 27.
citation: Hendriks JM, de Wit R, Vrijhoef HJ, Tieleman RG, Crijns HJ. An integrated chronic care program for patients with atrial fibrillation: study protocol and methodology for an ongoing prospective randomised controlled trial. Int J Nurs Stud. 2010 Oct;47(10):1310-6. doi: 10.1016/j.ijnurstu.2009.12.017. Epub 2010 Jan 20.