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

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00753259
First received: September 15, 2008
Last updated: April 19, 2010
Last verified: April 2010
  Purpose
  • 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.

Condition Intervention
Atrial Fibrillation
Other: AF Clinic
Other: Care as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes. [ Time Frame: minimum of 1 year ] [ Designated as safety issue: No ]

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. [ Time Frame: minimum of 1 year ] [ Designated as safety issue: No ]

Enrollment: 712
Study Start Date: June 2006
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AF Clinic Other: 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
Active Comparator: Care as Usual Other: Care as Usual
Routine clinical care of atrial fibrillation patients, provided by cardiologists, without the help of specialized nurses or dedicated software.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Newly diagnosed atrial fibrillation

Exclusion Criteria:

  • Age < 18 years
  • unwillingness to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753259

Locations
Netherlands
Martini Hospital Groningen
Groningen, Netherlands, 9700 RM
MaastrichtUMC
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Robert G Tieleman, MD PhD Maastricht UMC
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr RG Tieleman, MD, PhD, Dept of Cardiology, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00753259     History of Changes
Other Study ID Numbers: MEC 06-4-043
Study First Received: September 15, 2008
Last Updated: April 19, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
atrial fibrillation
disease management program
integrated chronic care program
guideline
stroke
heart failure
quality of life
costs

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 26, 2014