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

Atrial Fibrillation Clinical Trial

— AFClinic  

Official title:

The Effect of a Nurse-driven ICT-supported Disease Management Program to Improve the Treatment of Patients With Atrial Fibrillation.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753259
• Other study ID #: MEC 06-4-043
• Status: Completed
• Phase: N/A
• First received: September 15, 2008
• Last updated: April 19, 2010
• Start date: June 2006
• Est. completion date: January 2010

Study information

• Verified date: April 2010
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Newly diagnosed atrial fibrillation

Exclusion Criteria:

• Age < 18 years

• unwillingness to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Netherlands	Martini Hospital Groningen	Groningen
Netherlands	MaastrichtUMC	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of heart failure, thromboembolic complications, bleeding, severe adverse effects of drugs and death from cardiovascular causes.		minimum of 1 year	No
Secondary	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	No