<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/NCT03780777</url>
  </required_header>
  <id_info>
    <org_study_id>201811108</org_study_id>
    <secondary_id>MOHHU0040-17</secondary_id>
    <nct_id>NCT03780777</nct_id>
  </id_info>
  <brief_title>Removing Home Hazards for Older Adults in Affordable Housing</brief_title>
  <official_title>Removing Home Hazards for Older Adults in Affordable Housing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>US Department of Housing and Urban Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will conduct a hybrid effectiveness/implementation trial to simultaneously&#xD;
      establish the effectiveness of home hazard removal in affordable housing in order to reduce&#xD;
      falls, and conduct a process evaluation of how the intervention works in the context of&#xD;
      low-income senior apartments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators, in collaboration with the community partner, will offer the program to all&#xD;
      building residents in select low-income senior apartments. The eligibility criteria include a&#xD;
      self-report of one or more falls in the preceding 12 months, a fear of falling, or&#xD;
      unsteadiness while standing or walking. The investigators will screen residents and determine&#xD;
      their risk for falling. Residents who are high risk will be referred to licensed occupational&#xD;
      therapy practitioners for baseline assessments and home hazard removal. Residents will be&#xD;
      re-assessed at 3 months. All assessments will be conducted in the residents' apartment&#xD;
      buildings. Outcomes (falls, program evaluation) will be collected by our community partner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2019</start_date>
  <completion_date type="Actual">June 9, 2021</completion_date>
  <primary_completion_date type="Actual">June 9, 2021</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Resident enrollment in home hazard removal intervention</measure>
    <time_frame>609 days</time_frame>
    <description>Participation measured by percentage of eligible building residents enrolled</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Program fidelity</measure>
    <time_frame>609 days</time_frame>
    <description>Visit-by-visit checklist and calculation of the dose of the intervention received (number of minutes delivered)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of falls</measure>
    <time_frame>609 days</time_frame>
    <description>Prospective monthly reporting of falls using an automated phone system</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost per fall prevented</measure>
    <time_frame>609 days</time_frame>
    <description>Final prescription and invoice (materials)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to home hazard removal intervention recommendations</measure>
    <time_frame>609 days</time_frame>
    <description>Recommendations used/total at 3 months or cause of abandonment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">524</enrollment>
  <condition>Accidental Fall</condition>
  <arm_group>
    <arm_group_label>Home Hazard Removal Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A tailored home-modification (home-hazard removal) intervention for residents with a high fall risk, delivered in the home by occupational therapists over one to two visits and with a booster session at three months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home Hazard Removal</intervention_name>
    <description>Removal of home barriers or hazards</description>
    <arm_group_label>Home Hazard Removal Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residents who live in any of the eligible section 202 low-income senior apartment&#xD;
             units managed by our community partner&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals who do not reside in any of the eligible units&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Stark, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>older adult falls</keyword>
  <keyword>home hazards</keyword>
  <keyword>home barriers</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT03780777
org study id: 201811108
secondary id: MOHHU0040-17
nct id: NCT03780777
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators will conduct a hybrid effectiveness/implementation trial to simultaneously
      establish the effectiveness of home hazard removal in affordable housing in order to reduce
      falls, and conduct a process evaluation of how the intervention works in the context of
      low-income senior apartments.
The investigators, in collaboration with the community partner, will offer the program to all
      building residents in select low-income senior apartments. The eligibility criteria include a
      self-report of one or more falls in the preceding 12 months, a fear of falling, or
      unsteadiness while standing or walking. The investigators will screen residents and determine
      their risk for falling. Residents who are high risk will be referred to licensed occupational
      therapy practitioners for baseline assessments and home hazard removal. Residents will be
      re-assessed at 3 months. All assessments will be conducted in the residents' apartment
      buildings. Outcomes (falls, program evaluation) will be collected by our community partner.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Resident enrollment in home hazard removal intervention
time frame: 609 days
description: Participation measured by percentage of eligible building residents enrolled
measure: Program fidelity
time frame: 609 days
description: Visit-by-visit checklist and calculation of the dose of the intervention received (number of minutes delivered)
measure: Number of falls
time frame: 609 days
description: Prospective monthly reporting of falls using an automated phone system
measure: Cost per fall prevented
time frame: 609 days
description: Final prescription and invoice (materials)
measure: Adherence to home hazard removal intervention recommendations
time frame: 609 days
description: Recommendations used/total at 3 months or cause of abandonment
arm group label: Home Hazard Removal Group
arm group type: Experimental
description: A tailored home-modification (home-hazard removal) intervention for residents with a high fall risk, delivered in the home by occupational therapists over one to two visits and with a booster session at three months.
intervention type: Behavioral
intervention name: Home Hazard Removal
description: Removal of home barriers or hazards
arm group label: Home Hazard Removal Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Stark, PhD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No