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

May 7, 2014 updated by: Juhani Airaksinen, University of Turku

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Lieto, Finland, 21420
        • Härkätie community health center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 month control visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At 1 year followup

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 1 year followup visit
EQ5D based evaluation
1 year followup visit
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
5 year control

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Investigators

  • Principal Investigator: Juhani K Airaksinen, Professor, University of Turku

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

October 26, 2012

First Submitted That Met QC Criteria

November 1, 2012

First Posted (Estimate)

November 2, 2012

Study Record Updates

Last Update Posted (Estimate)

May 8, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T31/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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