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

Study Overview
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Brief Summary
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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.

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

Conditions
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Incidence of Atrial Fibrillation in Adults Aged ≥ 65

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults ≥ 65 with a positive test result<br>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<br>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?
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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 | 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. | 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. |  | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, screening, electrocardiogram, community pharmacy, Germany