ARENA - Project Atrial Fibrilation Rhine-Neckar Region (ARENA)

April 11, 2023 updated by: Stiftung Institut fuer Herzinfarktforschung

Af Register RhEin NeckAr - Projekt Vorhofflimmern Rhein Neckar

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

2777

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69120
        • Universitätsklinikum Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Not willing to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Prevented strokes in participants
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stiftung Institut fuer Herzinfarktforschung

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

July 19, 2021

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 28, 2016

First Posted (Estimate)

November 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARENA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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