Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto (LietoAF)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The aim of this study is to evaluate the feasibility of patient education on feeling the own pulse irregularity in the elderly population of Lieto.

Prevalence of atrial fibrillation (AF) rises with age. Subjects have often symptoms like palpitation and discomfort but especially in elderly population there's significant quantity of persons who don't feel any symptoms and fail to seek for medical care for stroke prevention.

The main objectives in this study are to find out the prevalence of AF in the elderly population of Lieto, to assess the feasibility and reability of patient education on feeling one's pulse irregularity and the affect to the quality of life of the participating subjects and monitoring the possible increased burden to the public health care system.

The study contains two office visits with specified learning session and long-term phone-call follow-up.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation; Stroke	Other: Subject education to pulse palpation	Not Applicable

Detailed Description:

The main objectives in this study are to find out the prevalence of AF in the elderly population of Lieto, to assess the feasibility of patient education on feeling one's pulse irregularity and the affect to the quality of life of the participating subjects and monitoring the possible increased burden to the public health care system.

The study contains two office visits with specified learning session and long-term phone-call follow-up. A specially trained nurse will initially give a 10 min education on pulse palpation to each person and evaluate their capacity to learn pulse palpation. During followup visits the compliance of the patient and possible new arrhythmias plus quality of life issues are recorded and their ability of pulse palpation is evaluated by artificial hand where various kinds of pulses are transmitted.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	200 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto
Study Start Date :	April 2012
Estimated Primary Completion Date :	November 2016
Estimated Study Completion Date :	December 2017

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
pulse palpation education; The subject is educated to pulse palpation by registered cardiac nurse. The education time is limited to 10 minutes and done according preplanned education model	Other: Subject education to pulse palpation; The subject is educated to pulse palpation by registered cardiac nurse. The education time is limited to 10 minutes and done according preplanned education model.

Outcome Measures

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Primary Outcome Measures :

1. The willingness to the pulse palpation and competence independently learn to feel own pulse. [ Time Frame: 1 month control visit ]
   Based on learning session evaluated by nurse and objective evaluation of the learned skills by pulse-arm device and patient's pulse diary

Secondary Outcome Measures :

1. Number of patients with new atrial fibrillation detected during the study [ Time Frame: At 1 year followup ]
   During the 1 year followup visit information on atrial fibrillation is gathered form the patients records and by interview

Other Outcome Measures:

1. Quality of life [ Time Frame: 1 year followup visit ]
   EQ5D based evaluation
2. New atrial fibrillation at long-term followup [ Time Frame: 5 year control ]
   Data on atrial fibrillation and thromboembolic complications is gathered from patient records and patient interview

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	75 Years and older (Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• patient aged 75 or over
• inhabitant of Lieto
• willing to participate

Exclusion Criteria:

• chronic atrial fibrillation
• ongoing anticoagulant treatment
• permanent institutional care

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Finland
Härkätie community health center
Lieto, Finland, 21420

Sponsors and Collaborators

University of Turku

Investigators

Principal Investigator:	Juhani K Airaksinen, Professor	University of Turku

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jaakkola J, Virtanen R, Vasankari T, Salminen M, Airaksinen KEJ. Self-detection of atrial fibrillation in an aged population: three-year follow-up of the LietoAF intervention study. BMC Geriatr. 2017 Sep 16;17(1):218. doi: 10.1186/s12877-017-0607-0.

Virtanen R, Kryssi V, Vasankari T, Salminen M, Kivelä SL, Airaksinen KE. Self-detection of atrial fibrillation in an aged population: the LietoAF Study. Eur J Prev Cardiol. 2014 Nov;21(11):1437-42. doi: 10.1177/2047487313494041. Epub 2013 Jun 18.

Responsible Party:	Juhani Airaksinen, Professor, University of Turku
ClinicalTrials.gov Identifier:	NCT01721005 History of Changes
Other Study ID Numbers:	T31/2012
First Posted:	November 2, 2012
Last Update Posted:	May 8, 2014
Last Verified:	May 2014

Keywords provided by Juhani Airaksinen, University of Turku:

atrial fibrillation; thromboembolism; patient education

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes