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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
AF Clinic
Care as Usual
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, disease management program, integrated chronic care program, guideline, stroke, heart failure, quality of life, costs

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Newly diagnosed atrial fibrillation

Exclusion Criteria:

  • Age < 18 years
  • unwillingness to participate

Sites / Locations

  • Martini Hospital Groningen
  • MaastrichtUMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AF Clinic

Care as Usual

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
September 15, 2008
Last Updated
April 19, 2010
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00753259
Brief Title
Atrial Fibrillation (AF) Clinic to Improve the Treatment of Patients With Atrial Fibrillation.
Acronym
AFClinic
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

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, disease management program, integrated chronic care program, guideline, stroke, heart failure, quality of life, costs

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
712 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AF Clinic
Arm Type
Experimental
Arm Title
Care as Usual
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
AF Clinic
Intervention Description
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
Intervention Name(s)
Care as Usual
Intervention Description
Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.
Primary Outcome Measure Information:
Title
Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes.
Time Frame
minimum of 1 year
Secondary Outcome Measure Information:
Title
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.
Time Frame
minimum of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed atrial fibrillation Exclusion Criteria: Age < 18 years unwillingness to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Tieleman, MD PhD
Organizational Affiliation
Maastricht UMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martini Hospital Groningen
City
Groningen
ZIP/Postal Code
9700 RM
Country
Netherlands
Facility Name
MaastrichtUMC
City
Maastricht
ZIP/Postal Code
6202 AZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24058179
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.
Results Reference
derived
PubMed Identifier
23305860
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.
Results Reference
derived
PubMed Identifier
22453654
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. Erratum In: Eur Heart J. 2013 Feb;34(6):408.
Results Reference
derived
PubMed Identifier
20089253
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.
Results Reference
derived

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

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