<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01721005</url>
  </required_header>
  <id_info>
    <org_study_id>T31/2012</org_study_id>
    <nct_id>NCT01721005</nct_id>
  </id_info>
  <brief_title>Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto</brief_title>
  <acronym>LietoAF</acronym>
  <official_title>Screening Versus Routine Practice in Detection of Atrial Fibrillation in the Elderly Population of Lieto</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turku</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turku</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the feasibility of patient education on feeling the own&#xD;
      pulse irregularity in the elderly population of Lieto.&#xD;
&#xD;
      Prevalence of atrial fibrillation (AF) rises with age. Subjects have often symptoms like&#xD;
      palpitation and discomfort but especially in elderly population there's significant quantity&#xD;
      of persons who don't feel any symptoms and fail to seek for medical care for stroke&#xD;
      prevention.&#xD;
&#xD;
      The main objectives in this study are to find out the prevalence of AF in the elderly&#xD;
      population of Lieto, to assess the feasibility and reability of patient education on feeling&#xD;
      one's pulse irregularity and the affect to the quality of life of the participating subjects&#xD;
      and monitoring the possible increased burden to the public health care system.&#xD;
&#xD;
      The study contains two office visits with specified learning session and long-term phone-call&#xD;
      follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objectives in this study are to find out the prevalence of AF in the elderly&#xD;
      population of Lieto, to assess the feasibility of patient education on feeling one's pulse&#xD;
      irregularity and the affect to the quality of life of the participating subjects and&#xD;
      monitoring the possible increased burden to the public health care system.&#xD;
&#xD;
      The study contains two office visits with specified learning session and long-term phone-call&#xD;
      follow-up. A specially trained nurse will initially give a 10 min education on pulse&#xD;
      palpation to each person and evaluate their capacity to learn pulse palpation. During&#xD;
      followup visits the compliance of the patient and possible new arrhythmias plus quality of&#xD;
      life issues are recorded and their ability of pulse palpation is evaluated by artificial hand&#xD;
      where various kinds of pulses are transmitted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2012</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The willingness to the pulse palpation and competence independently learn to feel own pulse.</measure>
    <time_frame>1 month control visit</time_frame>
    <description>Based on learning session evaluated by nurse and objective evaluation of the learned skills by pulse-arm device and patient's pulse diary</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with new atrial fibrillation detected during the study</measure>
    <time_frame>At 1 year followup</time_frame>
    <description>During the 1 year followup visit information on atrial fibrillation is gathered form the patients records and by interview</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 year followup visit</time_frame>
    <description>EQ5D based evaluation</description>
  </other_outcome>
  <other_outcome>
    <measure>New atrial fibrillation at long-term followup</measure>
    <time_frame>5 year control</time_frame>
    <description>Data on atrial fibrillation and thromboembolic complications is gathered from patient records and patient interview</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Atrial Fibrillation</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>pulse palpation education</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Subject education to pulse palpation</intervention_name>
    <description>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.</description>
    <arm_group_label>pulse palpation education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patient aged 75 or over&#xD;
&#xD;
          -  inhabitant of Lieto&#xD;
&#xD;
          -  willing to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic atrial fibrillation&#xD;
&#xD;
          -  ongoing anticoagulant treatment&#xD;
&#xD;
          -  permanent institutional care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juhani K Airaksinen, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turku</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Härkätie community health center</name>
      <address>
        <city>Lieto</city>
        <zip>21420</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>May 7, 2014</last_update_submitted>
  <last_update_submitted_qc>May 7, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turku</investigator_affiliation>
    <investigator_full_name>Juhani Airaksinen</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>atrial fibrillation</keyword>
  <keyword>thromboembolism</keyword>
  <keyword>patient education</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01721005
org study id: T31/2012
nct id: NCT01721005
lead sponsor: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The willingness to the pulse palpation and competence independently learn to feel own pulse.
time frame: 1 month control visit
description: Based on learning session evaluated by nurse and objective evaluation of the learned skills by pulse-arm device and patient's pulse diary
measure: Number of patients with new atrial fibrillation detected during the study
time frame: At 1 year followup
description: During the 1 year followup visit information on atrial fibrillation is gathered form the patients records and by interview
measure: Quality of life
time frame: 1 year followup visit
description: EQ5D based evaluation
measure: New atrial fibrillation at long-term followup
time frame: 5 year control
description: Data on atrial fibrillation and thromboembolic complications is gathered from patient records and patient interview
arm group label: pulse palpation education
arm group type: Other
description: 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
intervention type: Other
intervention name: Subject education to pulse palpation
description: 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.
arm group label: pulse palpation education
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Juhani K Airaksinen, Professor
role: Principal Investigator
affiliation: University of Turku
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: University of Turku
investigator full name: Juhani Airaksinen
investigator title: Professor
mesh term: Atrial Fibrillation