NCT00753259

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
712

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

April 20, 2010

Status Verified

April 1, 2010

Enrollment Period

3.6 years

First QC Date

September 15, 2008

Last Update Submit

April 19, 2010

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationdisease management programintegrated chronic care programguidelinestrokeheart failurequality of lifecosts

Outcome Measures

Primary Outcomes (1)

  • Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes.

    minimum of 1 year

Secondary Outcomes (1)

  • 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.

    minimum of 1 year

Study Arms (2)

AF Clinic

EXPERIMENTAL
Other: AF Clinic

Care as Usual

ACTIVE COMPARATOR
Other: Care as Usual

Interventions

AF ClinicOTHER

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

AF Clinic
Care as UsualOTHER

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

Care as Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed atrial fibrillation

You may not qualify if:

  • Age \< 18 years
  • unwillingness to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Martini Hospital Groningen

Groningen, 9700 RM, Netherlands

Location

MaastrichtUMC

Maastricht, 6202 AZ, Netherlands

Location

Related Publications (4)

  • 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.

    PMID: 24058179DERIVED

  • 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.

    PMID: 23305860DERIVED

  • 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.

    PMID: 22453654DERIVED

  • 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.

    PMID: 20089253DERIVED

MeSH Terms

Conditions

Atrial FibrillationStrokeHeart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Robert G Tieleman, MD PhD

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 16, 2008

Study Start

June 1, 2006

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

April 20, 2010

Record last verified: 2010-04

Locations

NL(2)