Atrial Fibrillation Clinical Trial
Official title:
Non-invasive Monitoring for Early Detection of Atrial Fibrillation
The aim of this project is to recognize the actual frequency of atrial fibrillation in the Polish population as well as to determine the independent risk factors for the occurrence of its clinically symptomatic and asymptomatic forms
The AF Survey is a cross-sectional observational study aimed to assess the prevalence and
control of AF and its correlation with CVD risk factors in Poland, based on a representative
sample of adults aged 65+. The main aim of the survey is to assess the prevalence,
detectability and control of AF, heart failure, vascular diseases, arterial hypertension,
stroke, sedentary lifestyle, smoking, lipid disorders, metabolic syndrome, obesity and
diabetes, as well as other factors related to CVD risk such as chronic kidney and liver
diseases, sleeping disorders, depression and selected psychosocial factors.
The assessment of AF prevalence with use of the monitoring system developed and validated
during the first phase of the project, would be composed of a questionnaire, follow-up data
sheet, blood pressure (BP) measurements and a blood sample collection.
The survey consists of three visits to subjects' homes (day: 1; 10+/-4 days and 30+/-4 days)
and one phone contact one year after first visit and would be performed by trained nurses.
The monitoring system would be installed during the first visit for all patients who sign
informed consent form and returned at the third visit one month later. The main questionnaire
will be completed during the first visit, which included detailed questions about present
health status and history of diseases, hospitalizations, and current medications. The
socioeconomic part of the questionnaire included questions concerning the personal and family
situation, economic status, household structure, leisure activities, hobbies, and social
life. During this visit the Geriatric scale of depression evaluation will be given to the
subject to be self-completed, and will be collected at the second visit. BP readings would be
taken three times during each visit to the patient's home. Anthropometric measurements are
taken twice: at visit one and visit three at the end of the ECG monitoring. Blood samples are
taken from subjects at the second visit after 10 to 12-hour fasting. The follow-up data sheet
would be completed at the initial visit and at the follow-up visit twelve months after
inclusion to the survey. The fieldwork is subcontracted to a company specializing in market
research projects for the private and public sectors. The transportation of biological
material to the Central Laboratory has been subcontracted to a company with expertise in
blood sample transport over long distances. Interviewers will be recruited from among
professionally active nurses. Most of them will be social nurses working within local
communities. All nurses participating in the survey will complete special training prepared
for fieldwork executors of the NOMED-AF project.
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