Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation.

NCT ID: NCT00753259

Last Updated: 2010-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

712 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-01-31

Brief Summary

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* 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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AF Clinic

Group Type EXPERIMENTAL

AF Clinic

Intervention Type OTHER

Treatment of atrial fibrillation patients by specialized nurses, supervised by cardiologists, using dedicated software to ensure maximal adherence to AHA/ACC/ESC guidelines on atrial fibrillation treatment

Care as Usual

Group Type ACTIVE_COMPARATOR

Care as Usual

Intervention Type OTHER

Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.

Interventions

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AF Clinic

Treatment of atrial fibrillation patients by specialized nurses, supervised by cardiologists, using dedicated software to ensure maximal adherence to AHA/ACC/ESC guidelines on atrial fibrillation treatment

Intervention Type OTHER

Care as Usual

Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed atrial fibrillation

Exclusion Criteria

* Age \< 18 years
* unwillingness to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Dept of Cardiology, Maastricht University Medical Center

Principal Investigators

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Robert G Tieleman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC

Locations

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Martini Hospital Groningen

Groningen, , Netherlands

Site Status

MaastrichtUMC

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 24058179 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23305860 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22453654 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20089253 (View on PubMed)

Other Identifiers

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MEC 06-4-043

Identifier Type: -

Identifier Source: org_study_id

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