Opportunistic Screening in Pharmacies for Atrial Fibrillation in Seniors (>65 Years) (AF-Stroke)

March 10, 2020 updated by: Nikolaus Marx, RWTH Aachen University

Eine Beobachtungsstudie Zur Erfassung Von (Asymptomatischem)Vorhofflimmern Mittels Eines Gelegenheitsscreenings älteren Menschen ab 65 Jahren

Atrial fibrillation (AF) is the most common arrhythmia in Germany and is associated with an increased risk of thromboembolic stroke. The risk to suffer from AF increases with age. Early detection of AF and anticoagulation seem the most effective way of preventing ischaemic stroke in patients at risk. The guidelines of the European Society of Cardiology recommend opportunistic screening for AF by pulse check at each general practitioner visit for all patients aged 65 years or older.

The objective of this study was to test whether an opportunistic AF screening with a hand-held diagnostic tool in a German pharmacy setting is useful in detecting unknown AF among people in the age of 65 and older. Besides a pulse palpation with a hand-held ECG-stick the screening in the pharmacies also includes a questionnaire related to demographics and medical history of the subject as well as several questions concerning the stroke risk stratification (CHA₂DS₂-VASc). Every subject with a positive test result (indication on AF) is insistently asked to make an appointment with his or her general practitioner. The subject receives an information letter for his or her general practitioner that adverts to the positive screening result and the necessity of further diagnostic Investigation.

In order to assess the incidence of unknown AF as well as accomplish the secondary objectives of this study, two follow-ups by means of telephone interviews are performed. First, all subjects with a positive test result are called 8 weeks after the screening in the pharmacies was conducted. The subject is asked several questions concerning personal data/demographics, the stroke risk (CHA₂DS₂-VASc), the medical history regarding to dyspnea and stroke, the bleeding risk (HAS-Bled), the medication, the device, diagnostic, the therapy, the Intervention and the mace. 12 months after the screening in the pharmacies was performed, all participating subjects were called. The list of questions is similar to the one that is used during the first telephone interviews after eight weeks.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

7606

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
      • Aachen, Germany, 52074
        • Uniklinium RWTH Aachen

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

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All pharmacy customers (male and female) of 65 years and above that meet the inclusion criteria and are not affected by the exclusion criteria are allowed to participate in this study.

Description

Inclusion Criteria:

  • At least 65 years or older
  • Signed informed consent
  • Signed subject information

Exclusion Criteria:

  • Insufficient language skills
  • Limited cognitive abilities
  • Limited physical abilities (i.e. tremor)

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

Cohorts and Interventions

Group / Cohort
Adults ≥ 65 with a positive test result
Adults ≥ 65 that are got a positive test result were asked to visit their general practitioner and are called for an interview two times, 8 weeks and 12 months after the screening in the pharmacy. The results of the data collection and screening in the pharmacies as well as of the two telephone interviews are compared to the results of the adults ≥ 65 with a negative test result.
Adults ≥ 65 with a negative test result
Adults ≥ 65 that are got a negative test result are called for an interview 12 months after the screening in the pharmacy. The results of the data collection and screening in the pharmacy as well as of the telephone interview are compared to the results of the adults ≥ 65 with a positive test result.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of newly detected atrial fibrillation in adults from the age of 65 by means of an opportunistic screening with an ECG hand-held diagnostic tool in a pharmacy setting
Time Frame: 12 months
The data is going to be collected in a screening period of two weeks in an urban pharmacy setting and a screening period of two weeks of data collection in a more rural pharmacy setting
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The subject's behavior change regarding diagnosis and therapy from the ECG measurement at pharmacy at 8 weeks and 12 months.
Time Frame: 8 weeks and 12 Months
The subject's behavior change is measured by means of a questionnaire, compiled by the research team. The questionnaire is used during the telephone interviews 8 eight weeks and 12 months. The questionnaire includes questions related to personal data/demographics, the stroke risk (CHA₂DS₂-VASc), the medical history regarding to dyspnea and stroke, the bleeding risk (HAS-Bled), the medication, the device, diagnostic, the therapy, the Intervention and the mace.
8 weeks and 12 Months
Identification and description of new therapeutic measures.
Time Frame: 12 Months
12 Months

Collaborators and Investigators

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

Sponsor

RWTH Aachen University

Collaborators

Pfizer
Apothekerverband Aachen e.V.

Investigators

  • Principal Investigator: Nikolaus Marx, Professor, Head of the Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 1, 2017

Primary Completion (ACTUAL)

August 22, 2018

Study Completion (ACTUAL)

August 22, 2018

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (ESTIMATE)

December 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-073 AF-Stroke

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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