Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients

NCT ID: NCT01928121

Last Updated: 2013-08-26

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this study is to assess the effectiveness of a newly developed interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a prospective, pragmatic clustered randomized controlled trial will be performed in general practices.

Detailed Description

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Conditions

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Atrial Fibrillation

Keywords

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nurse expert program primary care implementation interdisciplinary effectiveness disease management system

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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AF expert program

Care provided by the interdisciplinary, nurse-coordinated AF expert program

Group Type EXPERIMENTAL

Care provided by AF expert program

Intervention Type OTHER

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Care provided by AF expert program

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Every newly diagnosed AF patient.
* Every AF patient who is not seen by a cardiologist or electrophysiologist in the past 2 years before inclusion.
* AF must be confirmed on electrocardiogram.
* Capable of providing written informed consent.
* Dutch speaking and verbally testable, without cognitive impairment.

Exclusion Criteria

* AF patients who once received an arrhythmologic consult about AF prior to the start of the study.
* AF patients who have a systematic follow-up at a cardiologist prior to the start of the study.
* Terminally ill AF patients
* Participation in another clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Prof Heidbuchel

Prof. Hein Heidbuchel, MD, PHD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UZ Leuven

Leuven, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

Central Contacts

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Dana Berti

Role: CONTACT

Phone: 0032-479-845016

Email: [email protected]

Hein Heidbuchel

Role: CONTACT

Phone: 0032-16-344248

Email: [email protected]

Facility Contacts

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Dana Berti

Role: primary

Hein Heidbuchel

Role: backup

Other Identifiers

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not yet applicable

Identifier Type: -

Identifier Source: org_study_id