<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/NCT02995317</url>
  </required_header>
  <id_info>
    <org_study_id>FOU-UU-006</org_study_id>
    <nct_id>NCT02995317</nct_id>
  </id_info>
  <brief_title>Who is Falling? - Fall Risk Prediction Among Community Dwelling Elderly.</brief_title>
  <acronym>NOCfao</acronym>
  <official_title>The ≥65 Years NOrthern Jutland Cohort of Fall Risk Assessment With Objective Measurements (the NOCfao Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College of Northern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aalborg Municipality, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aalborg University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College of Northern Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate if the level of physical activity, selected&#xD;
      physical and psychological risk factors can predict risk of falling in older (≥65) community&#xD;
      dwellers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported number of falls confirmed by monthly phone calls</measure>
    <time_frame>One year follow-up</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Accidental Fall</condition>
  <arm_group>
    <arm_group_label>Fall accidents</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Number of falls based on an one year follow-up</intervention_name>
    <arm_group_label>Fall accidents</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will be undertaken in Aalborg Municipality at different activity-centers and&#xD;
        nursing homes in collaboration with care workers, nurses and staff at the activity centers,&#xD;
        all employed at the Department of Elderly and Health. Furthermore the project manager&#xD;
        arranges briefing meetings with groups of employees in order to provide clarification of&#xD;
        the project and encourage support of the recruitment of the study-population. Participants&#xD;
        satisfying the inclusion and exclusion criteria is contacted by the project group, to&#xD;
        ensure that they fully understand what it takes to participate. Subsequently, an&#xD;
        appointment for completion of the baseline data is made.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Home dwelling&#xD;
&#xD;
          -  Manage body transfer independently&#xD;
&#xD;
          -  Walking ability for at least 10 meters with or without assistive devices&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Progressive neurological or rheumatologically illness&#xD;
&#xD;
          -  Diagnosed vestibular problems&#xD;
&#xD;
          -  Experienced pain in a substantial degree, limiting or obstructing everyday living&#xD;
&#xD;
          -  Known uncorrected visual or hearing problems.&#xD;
&#xD;
          -  Serious difficulties in speaking, understanding or reading Danish.&#xD;
&#xD;
          -  Cognitive impairment equivalent to Mini Mental State Examination &lt; 23&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bo Grarup</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College of Northern Denmark</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bo Grarup</last_name>
    <phone>+4572690953</phone>
    <email>bog@ucn.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>University College of Northern Denmark</name>
      <address>
        <city>Aalborg</city>
        <zip>9220</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bo Grarup, Lecturer</last_name>
      <phone>+4572690953</phone>
      <email>bog@ucn.dk</email>
    </contact>
    <contact_backup>
      <last_name>Rogerio Pessoto Hirata, PhD</last_name>
      <phone>+4599409838</phone>
      <email>rirata@hst.aau.dk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>April 14, 2020</last_update_submitted>
  <last_update_submitted_qc>April 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Aged</keyword>
  <keyword>Gait</keyword>
  <keyword>Postural Balance</keyword>
  <keyword>Accelerometry</keyword>
  <keyword>Physical Activity</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02995317
org study id: FOU-UU-006
nct id: NCT02995317
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The purpose of this study is to investigate if the level of physical activity, selected
      physical and psychological risk factors can predict risk of falling in older (≥65) community
      dwellers.
observational model: Cohort
time perspective: Prospective
measure: Self-reported number of falls confirmed by monthly phone calls
time frame: One year follow-up
arm group label: Fall accidents
intervention type: Other
intervention name: Number of falls based on an one year follow-up
arm group label: Fall accidents
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bo Grarup
role: Principal Investigator
affiliation: University College of Northern Denmark
last name: Bo Grarup
phone: +4572690953
email: bog@ucn.dk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Denmark
responsible party type: Sponsor
sharing ipd: Undecided