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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Juhani Airaksinen, University of Turku
ClinicalTrials.gov Identifier:
NCT01721005
First received: October 26, 2012
Last updated: May 7, 2014
Last verified: May 2014
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    EQ5D based evaluation

  • New atrial fibrillation at long-term followup [ Time Frame: 5 year control ] [ Designated as safety issue: No ]
    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
Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Juhani Airaksinen, Professor, University of Turku
ClinicalTrials.gov Identifier: NCT01721005     History of Changes
Other Study ID Numbers: T31/2012
Study First Received: October 26, 2012
Last Updated: May 7, 2014
Health Authority: Finland: National Advisory Board on Health Care Ethics

Keywords provided by University of Turku:
atrial fibrillation
thromboembolism
patient education

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on March 03, 2015