Clinical trial NCT02978248: ARENA - Project Atrial Fibrilation Rhine-Neckar Region
Official title: Af Register RhEin NeckAr - Projekt Vorhofflimmern Rhein Neckar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 2777
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with atrial fibrilation in the Rhein-Neckar Region in Germany, recruted by their general practitioner or during a hospital stay.

Brief summary: ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.

The study design includes three study arms:

1. ARENA Intervention: This project will examine the effectiveness of population education.
2. ARENA Medication: The aim is to examine the patient's adherence and to analyze whether there are any complications.
3. ARENA Migration: ARENA migration aims to examine whether a targeted population education can improve the care of people with a Turkish migration background.

Detailed description: ARENA aims to inform patients about the symptoms and the risks of atrial fibrilation.

The study design includes three study arms:

1. ARENA Intervention:

   This project will examine the effectiveness of population education and other measures to provide care for patients with atrial fibrillation.

   In the end of the control phase (1 year recruitment of approximately 10,000 patients), there will be a wide publicity, informing about the disease.
2. ARENA Medication:

   ARENA records the patient's complete medication at all survey times (up to two weeks after recruitment and follow up). This allows an accurate assessment of interactions between individual substances.

   In addition, attempts are being made to determine drug concentrations of anticoagulants directly by the blood of the patient. Therefore, patients are provided with kits, which they can use to apply a drop of blood from your fingertip to a filter paper. The aim is to examine the patient's adherence and to analyze whether there are any complications.
3. ARENA Migration:

The Metropolregion Rhein-Neckar is characterized by a high proportion of people with a Turkish migration background. ARENA migration aims to examine whether a targeted population education can improve the care of this patient group.

Eligibility criteria: Inclusion Criteria:

* Willingness to participate
* Atiral fibrilation
* 18 years or older

Exclusion Criteria:

* Not willing to participate

Primary outcomes:
measure: Number of Prevented strokes in participants
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
state: Baden-Württemberg
Study officials:
affiliation: Universitätsmedizin Mannheim
name: Martin Borggrefe, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Heidelberg
name: Walter E. Haefeli, Prof. Dr.
role: STUDY_CHAIR
affiliation: Praxis Merz Sanatci
name: Ömer Sanatci, Dr. med.
role: STUDY_CHAIR
References: