<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/NCT03253419</url>
  </required_header>
  <id_info>
    <org_study_id>Pro48620</org_study_id>
    <nct_id>NCT03253419</nct_id>
  </id_info>
  <brief_title>HotShOT: Home Safety Occupational Therapy</brief_title>
  <acronym>HotShOT</acronym>
  <official_title>Exploration of Home Safety Application Impact on Perceived Risk of Falling and Actual Falls Post Hospital Discharge</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Home for Life Design</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</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 purpose of this research study is to examine home safety and fall risk for patients who&#xD;
      have undergone hip replacement surgery. The investigators want to know whether evaluating&#xD;
      home safety impacts perceived and real risk of falls at home. The study will utilize a fall&#xD;
      risk assessment which is a questionnaire that focuses on perceived and real risk of falls at&#xD;
      home, as well as a home safety assessment application, the Home for Life App. The participant&#xD;
      will be asked about the home environment, including areas of the home such as the entrance,&#xD;
      bedroom, and bathroom, and modification recommendations will be made to potentially increase&#xD;
      safety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the Centers for Disease Control (CDC), 2.8 million older adults were treated in&#xD;
      the emergency department for fall related injuries. Most falls are caused by a combination of&#xD;
      risk factors, with more risk factors leading to an increased risk for falling.&#xD;
&#xD;
      People undergoing a total hip replacement can be seen as having an increased risk of falling.&#xD;
      Once an individual discharges home from the hospital, it is during this continued&#xD;
      post-operative period where pain and weakness continues to effect their walking ability.&#xD;
      Additionally, if the patient has a history of falling, has a fear of falling, has visual&#xD;
      deficits, and/or neuropathy, risk of falling increases.&#xD;
&#xD;
      Evaluating a patient's fear of falling and educating patient's regarding home safety may lead&#xD;
      to a patient feeling increased confidence when completing daily activities with increased&#xD;
      safety awareness.&#xD;
&#xD;
      The purpose of this study is to evaluate the use of the Home for Life mobile application to&#xD;
      examine home safety and fall risk for patients who have undergone hip replacement surgery and&#xD;
      are being discharged to their home.&#xD;
&#xD;
      Study Aims:&#xD;
&#xD;
        1. The first aim of this study is to assess whether completion of a home safety assessment&#xD;
           within an acute care setting will facilitate carryover and reduce a person's actual and&#xD;
           perceived risk of falling. The Home Safety Assessment tool will be used to make&#xD;
           adaptation recommendations to a person's home setting based on their real and perceived&#xD;
           risk of falling in different rooms within the home (entrance, bedroom, bathroom at a&#xD;
           minimum). A home safety assessment is a standard in the clinical care provided by&#xD;
           occupational therapist (OT). The use of the home safety application being an alternative&#xD;
           method of gathering the information is for research purposes in this study and is not&#xD;
           currently used in daily operations. During the initial evaluation, the occupational&#xD;
           therapist will bring a tablet into the room. The tablet will have the downloaded&#xD;
           user-friendly application. The therapist will guide the client through the components of&#xD;
           the application, identifying different rooms in their home and asking questions&#xD;
           pertaining to their real and perceived risk of falling within these rooms. Information&#xD;
           obtained during this process will then be stored on RedCap.&#xD;
&#xD;
        2. The second aim of this study will be to determine if recommended adaptations in home&#xD;
           safety impacted perceived risk of falling.&#xD;
&#xD;
        3. The third aim of this study will be to determine if the patient had a fall within two&#xD;
           weeks post discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Change in staffing and not able to do study&#xD;
  </why_stopped>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</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>
    <intervention_model_description>To evaluate the use of the Home for Life mobile application to examine home safety and perceived fall risk and actual falls within 2 weeks of hospital discharge for participants who have undergone hip replacement surgery.</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Relationship of Use of Home safety assessment and Perceived Risk of Falling</measure>
    <time_frame>Identified during Initial evaluation</time_frame>
    <description>Number of participants who identified perceived risk of falling and number of participants who used of home safety application</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Actual Fall and Use of application/adaptations</measure>
    <time_frame>2 weeks of hospital discharge</time_frame>
    <description>Relationship of participant actual fall within 2 weeks of hospital discharge and use of home safety application/adaptations. Number of participants who utilized home safety application/adaptation and number of participants who had an actual fall</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Hip Replacement</condition>
  <arm_group>
    <arm_group_label>Home Safety Application</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Use of Home Safety application as part of assessment for home safety. The only intervention is the use of the home safety application and identification of home safety issues by the patient using this application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home for Life mobile application</intervention_name>
    <description>Utilize home application to provide the participant with an understanding and recommendations to potentially decrease home hazards that may lead to risk of falls in their home.</description>
    <arm_group_label>Home Safety Application</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective total hip arthroplasty&#xD;
&#xD;
          -  Discharge destination from acute care hospital is to home&#xD;
&#xD;
          -  ≥ 65 years old&#xD;
&#xD;
          -  Prior to admission, independent in activities of daily living&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hip replacement due to trauma&#xD;
&#xD;
          -  Discharge plan to skilled nursing facility, long term care hospital or inpatient&#xD;
             rehabilitation facility&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Riggs, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Cedars-Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cedars-Sinai Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90048</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>February 28, 2020</last_update_submitted>
  <last_update_submitted_qc>February 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Pamela Roberts</investigator_full_name>
    <investigator_title>Director and Professor</investigator_title>
  </responsible_party>
  <keyword>Falls</keyword>
  <keyword>Hip Replacement</keyword>
  <keyword>Home Safety</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans to share IPD at this time</ipd_description>
  </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/NCT03253419
org study id: Pro48620
nct id: NCT03253419
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to examine home safety and fall risk for patients who
      have undergone hip replacement surgery. The investigators want to know whether evaluating
      home safety impacts perceived and real risk of falls at home. The study will utilize a fall
      risk assessment which is a questionnaire that focuses on perceived and real risk of falls at
      home, as well as a home safety assessment application, the Home for Life App. The participant
      will be asked about the home environment, including areas of the home such as the entrance,
      bedroom, and bathroom, and modification recommendations will be made to potentially increase
      safety.
According to the Centers for Disease Control (CDC), 2.8 million older adults were treated in
      the emergency department for fall related injuries. Most falls are caused by a combination of
      risk factors, with more risk factors leading to an increased risk for falling.

      People undergoing a total hip replacement can be seen as having an increased risk of falling.
      Once an individual discharges home from the hospital, it is during this continued
      post-operative period where pain and weakness continues to effect their walking ability.
      Additionally, if the patient has a history of falling, has a fear of falling, has visual
      deficits, and/or neuropathy, risk of falling increases.

      Evaluating a patient's fear of falling and educating patient's regarding home safety may lead
      to a patient feeling increased confidence when completing daily activities with increased
      safety awareness.

      The purpose of this study is to evaluate the use of the Home for Life mobile application to
      examine home safety and fall risk for patients who have undergone hip replacement surgery and
      are being discharged to their home.

      Study Aims:

        1. The first aim of this study is to assess whether completion of a home safety assessment
           within an acute care setting will facilitate carryover and reduce a person's actual and
           perceived risk of falling. The Home Safety Assessment tool will be used to make
           adaptation recommendations to a person's home setting based on their real and perceived
           risk of falling in different rooms within the home (entrance, bedroom, bathroom at a
           minimum). A home safety assessment is a standard in the clinical care provided by
           occupational therapist (OT). The use of the home safety application being an alternative
           method of gathering the information is for research purposes in this study and is not
           currently used in daily operations. During the initial evaluation, the occupational
           therapist will bring a tablet into the room. The tablet will have the downloaded
           user-friendly application. The therapist will guide the client through the components of
           the application, identifying different rooms in their home and asking questions
           pertaining to their real and perceived risk of falling within these rooms. Information
           obtained during this process will then be stored on RedCap.

        2. The second aim of this study will be to determine if recommended adaptations in home
           safety impacted perceived risk of falling.

        3. The third aim of this study will be to determine if the patient had a fall within two
           weeks post discharge.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: To evaluate the use of the Home for Life mobile application to examine home safety and perceived fall risk and actual falls within 2 weeks of hospital discharge for participants who have undergone hip replacement surgery.
primary purpose: Health Services Research
masking: None (Open Label)
measure: Relationship of Use of Home safety assessment and Perceived Risk of Falling
time frame: Identified during Initial evaluation
description: Number of participants who identified perceived risk of falling and number of participants who used of home safety application
measure: Actual Fall and Use of application/adaptations
time frame: 2 weeks of hospital discharge
description: Relationship of participant actual fall within 2 weeks of hospital discharge and use of home safety application/adaptations. Number of participants who utilized home safety application/adaptation and number of participants who had an actual fall
arm group label: Home Safety Application
arm group type: Other
description: Use of Home Safety application as part of assessment for home safety. The only intervention is the use of the home safety application and identification of home safety issues by the patient using this application.
intervention type: Other
intervention name: Home for Life mobile application
description: Utilize home application to provide the participant with an understanding and recommendations to potentially decrease home hazards that may lead to risk of falls in their home.
arm group label: Home Safety Application
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Riggs, MD
role: Study Chair
affiliation: Cedars-Sinai
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Pamela Roberts
investigator title: Director and Professor
sharing ipd: No
ipd description: No plans to share IPD at this time