<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/NCT03294447</url>
  </required_header>
  <id_info>
    <org_study_id>15082105-IRB01</org_study_id>
    <nct_id>NCT03294447</nct_id>
  </id_info>
  <brief_title>An Occupational Therapist Fall Prevention Intervention in a Geriatric Primary Care Setting</brief_title>
  <official_title>The Association Between Fear of Falling and Fall Prevention Interventions Offered by an Occupational Therapist in a Geriatric Primary Care Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Western Michigan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rush University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose of the study: To identify if an intervention focused on decreasing fear of falling&#xD;
      (FOF) in a geriatric primary care setting implemented by an occupational therapist (OT) has&#xD;
      the potential to decrease falls and improve physical, psychological and social factors&#xD;
      related to FOF.&#xD;
&#xD;
      The primary research question: Is there an association between fear of falling among&#xD;
      geriatric populations and fall prevention interventions that are offered by occupational&#xD;
      therapist in a geriatric primary care setting?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">December 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change of Falls Efficacy Scale-International (FES-I), standardized measure for fear of falling</measure>
    <time_frame>One Time visit: 30-50 minutes</time_frame>
    <description>The outcome measure is the change between the pre FES-I and post FES-I</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Fall Accident</condition>
  <condition>Fall, Accidental</condition>
  <arm_group>
    <arm_group_label>Fall Prevention Intervention by OT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fall prevention interventions implemented by an OT in a geriatric primary care setting for a client immediately following the provider visit within the office.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fall Prevention by the Occupational Therapist</intervention_name>
    <description>The interventions included education on adaptive equipment for household activities, adaptive equipment for activities of daily living, proper footwear in all environments, proper body mechanics, position changes, home environment set up, high fall risk activities, safety awareness, low vision and home exercises programs. In addition, discussion and education occurred to improve participation in valued occupations.</description>
    <arm_group_label>Fall Prevention Intervention by OT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  cognitively intact with a score of 29/30 or higher on the Orientation Log&#xD;
             (standardized assessment tool)&#xD;
&#xD;
          -  living in the community&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  had a fall or near fall in the past year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  received OT services within the past 2 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lydia Royeen, Masters</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rush University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geriatric Primary Care Clinic</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>May 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>December 11, 2020</last_update_submitted>
  <last_update_submitted_qc>December 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rush University Medical Center</investigator_affiliation>
    <investigator_full_name>Lydia Royeen</investigator_full_name>
    <investigator_title>Senior Occupational Therapist</investigator_title>
  </responsible_party>
  <keyword>Fear of falling</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/NCT03294447
org study id: 15082105-IRB01
nct id: NCT03294447
lead sponsor: 
collaborator: 
has dmc: No
Purpose of the study: To identify if an intervention focused on decreasing fear of falling
      (FOF) in a geriatric primary care setting implemented by an occupational therapist (OT) has
      the potential to decrease falls and improve physical, psychological and social factors
      related to FOF.

      The primary research question: Is there an association between fear of falling among
      geriatric populations and fall prevention interventions that are offered by occupational
      therapist in a geriatric primary care setting?
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Change of Falls Efficacy Scale-International (FES-I), standardized measure for fear of falling
time frame: One Time visit: 30-50 minutes
description: The outcome measure is the change between the pre FES-I and post FES-I
arm group label: Fall Prevention Intervention by OT
arm group type: Experimental
description: Fall prevention interventions implemented by an OT in a geriatric primary care setting for a client immediately following the provider visit within the office.
intervention type: Behavioral
intervention name: Fall Prevention by the Occupational Therapist
description: The interventions included education on adaptive equipment for household activities, adaptive equipment for activities of daily living, proper footwear in all environments, proper body mechanics, position changes, home environment set up, high fall risk activities, safety awareness, low vision and home exercises programs. In addition, discussion and education occurred to improve participation in valued occupations.
arm group label: Fall Prevention Intervention by OT
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lydia Royeen, Masters
role: Principal Investigator
affiliation: Rush University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rush University Medical Center
investigator full name: Lydia Royeen
investigator title: Senior Occupational Therapist
sharing ipd: Undecided