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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2014 by Juhani Airaksinen, University of Turku.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01721005
First Posted: November 2, 2012
Last Update Posted: May 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juhani Airaksinen, University of Turku
  Purpose

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 Intervention
Atrial Fibrillation Stroke Other: Subject education to pulse palpation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Juhani Airaksinen, University of Turku:

Primary Outcome Measures:
  • 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:
  • 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:
  • Quality of life [ Time Frame: 1 year followup visit ]
    EQ5D based evaluation

  • 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


Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721005


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juhani Airaksinen, Professor, University of Turku
ClinicalTrials.gov Identifier: NCT01721005     History of Changes
Other Study ID Numbers: T31/2012
First Submitted: October 26, 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