Clinical trial NCT03004859: Opportunistic Screening in Pharmacies for Atrial Fibrillation in Seniors (>65 Years)
Official title: Eine Beobachtungsstudie Zur Erfassung Von (Asymptomatischem)Vorhofflimmern Mittels Eines Gelegenheitsscreenings älteren Menschen ab 65 Jahren
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incidence of Atrial Fibrillation in Adults Aged ≥ 65
Keywords: atrial fibrillation
screening
electrocardiogram
community pharmacy
Germany
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: Apothekerverband Aachen e.V.
name: Pfizer
First posted: 2016-12-29
Enrollment: 7606
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: The subject's behavior change regarding diagnosis and therapy from the ECG measurement at pharmacy at 8 weeks and 12 months.
timeFrame: 8 weeks and 12 Months
measure: Identification and description of new therapeutic measures.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Uniklinium RWTH Aachen
Study officials:
affiliation: Head of the Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine
name: Nikolaus Marx, Professor
role: PRINCIPAL_INVESTIGATOR
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