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

NCT03004859

Last updated date
Study Location
Uniklinium RWTH Aachen
Aachen, , 52074, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Incidence of Atrial Fibrillation in Adults Aged ≥ 65
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- At least 65 years or older

- Signed informed consent

- Signed subject information

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Insufficient language skills


- Limited cognitive abilities


- Limited physical abilities (i.e. tremor)

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Incidence of Atrial Fibrillation in Adults Aged ≥ 65Opportunistic Screening in Pharmacies for Atrial Fibrillation in Seniors (>65 Years)
NCT03004859
  1. Aachen,
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title 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
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 (CHA?DS?-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 (CHA?DS?-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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
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.
Condition Incidence of Atrial Fibrillation in Adults Aged ? 65
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 14, 2017)
7606
Original Estimated Enrollment
 (submitted: December 22, 2016)
6000
Actual Study Completion Date August 22, 2018
Actual Primary Completion Date August 22, 2018   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study:All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03004859
Other Study ID Numbers 15-073 AF-Stroke
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:Undecided
Responsible Party Nikolaus Marx, RWTH Aachen University
Study Sponsor RWTH Aachen University
Collaborators
  • Apothekerverband Aachen e.V.
  • Pfizer
Investigators
Principal Investigator:Nikolaus Marx, ProfessorHead of the Clinic for Cardiology, Pneumology, Angiology and Internal Intensive Medicine
PRS Account RWTH Aachen University
Verification Date April 2018