<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/NCT03028493</url>
  </required_header>
  <id_info>
    <org_study_id>01633</org_study_id>
    <nct_id>NCT03028493</nct_id>
  </id_info>
  <brief_title>Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision</brief_title>
  <official_title>Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sarah Blaylock</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      This study serves to test a previously evaluated falls prevention intervention recommended by&#xD;
      the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the&#xD;
      Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is&#xD;
      accessible to older adults with low vision receiving services from the Southeastern Blind&#xD;
      Rehabilitation Center (SBRC). This study also serves to pilot a version of the SAFE&#xD;
      intervention that has been adapted to be accessible for individuals with low vision at SBRC.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study serves to compare the comprehension and retention of individuals completing a&#xD;
      version of the SAFE falls prevention intervention adapted for low vision versus individuals&#xD;
      receiving the original intervention. One group of participants will complete the standard&#xD;
      SAFE intervention format while another group will complete the same intervention with written&#xD;
      materials adapted for those with vision loss. One intervention (either standard or adapted&#xD;
      SAFE program) will be delivered at a time. The SAFE intervention is comprised of four,&#xD;
      90-minute group classes that address environmental, behavioral, and physical falls risk&#xD;
      factors. Classes involve lecture and group discussions as well as review of low intensity&#xD;
      exercises. The adapted content is presented in large print with high contrast and has been&#xD;
      rewritten on a lower grade level. A nutritionist, a physical therapist, a physician, 5 older&#xD;
      adults with low vision, 10 low vision occupational therapist, and 5 health literacy experts&#xD;
      provided feedback to strengthen the adapted intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 18, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Three individuals not involved in intervention delivery will complete pre-post measures.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in knowledge of falls prevention</measure>
    <time_frame>Pre and post (2 weeks after start of intervention delivery)</time_frame>
    <description>10 multiple choice questions based on the SAFE intervention content</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Short Physical Performance Battery</measure>
    <time_frame>Pre</time_frame>
    <description>Measures of balance, gait, and sit to stand</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Depression Scale</measure>
    <time_frame>Pre</time_frame>
    <description>Measures depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Participation Scale</measure>
    <time_frame>Pre</time_frame>
    <description>Measures daily participation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Global Health</measure>
    <time_frame>Pre</time_frame>
    <description>Measures general health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>UAB Life-Space Inventory</measure>
    <time_frame>Pre</time_frame>
    <description>Measures places travelled within past month</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Low Vision</condition>
  <condition>Fall</condition>
  <arm_group>
    <arm_group_label>Adapted SAFE Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adapted version of the SAFE Health Behavior and Exercise intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Original SAFE Intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Original version of the SAFE intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Original SAFE Intervention</intervention_name>
    <description>A CDC recommended, evidence-based falls prevention intervention.</description>
    <arm_group_label>Original SAFE Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adapted SAFE Intervention</intervention_name>
    <description>An adapted version of the SAFE intervention meant to target older adults with low vision.</description>
    <arm_group_label>Adapted SAFE Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  60 and older;&#xD;
&#xD;
          -  Visual impairment with some remaining reading ability.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than age 60;&#xD;
&#xD;
          -  Complete blindness;&#xD;
&#xD;
          -  Vertebral osteoporosis.&#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>Cynthia Brown, MD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Birmingham VA and UAB School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Veteran Affairs</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 2, 2018</last_update_submitted>
  <last_update_submitted_qc>January 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Sarah Blaylock</investigator_full_name>
    <investigator_title>Doctoral Candidate Department of Occupational Therapy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vision, Low</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All data serves to fulfill dissertation requirement and will not be shared with additional researchers.</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/NCT03028493
org study id: 01633
nct id: NCT03028493
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study serves to test a previously evaluated falls prevention intervention recommended by
      the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the
      Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is
      accessible to older adults with low vision receiving services from the Southeastern Blind
      Rehabilitation Center (SBRC). This study also serves to pilot a version of the SAFE
      intervention that has been adapted to be accessible for individuals with low vision at SBRC.
This study serves to compare the comprehension and retention of individuals completing a
      version of the SAFE falls prevention intervention adapted for low vision versus individuals
      receiving the original intervention. One group of participants will complete the standard
      SAFE intervention format while another group will complete the same intervention with written
      materials adapted for those with vision loss. One intervention (either standard or adapted
      SAFE program) will be delivered at a time. The SAFE intervention is comprised of four,
      90-minute group classes that address environmental, behavioral, and physical falls risk
      factors. Classes involve lecture and group discussions as well as review of low intensity
      exercises. The adapted content is presented in large print with high contrast and has been
      rewritten on a lower grade level. A nutritionist, a physical therapist, a physician, 5 older
      adults with low vision, 10 low vision occupational therapist, and 5 health literacy experts
      provided feedback to strengthen the adapted intervention.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: Three individuals not involved in intervention delivery will complete pre-post measures.
measure: Change in knowledge of falls prevention
time frame: Pre and post (2 weeks after start of intervention delivery)
description: 10 multiple choice questions based on the SAFE intervention content
measure: Short Physical Performance Battery
time frame: Pre
description: Measures of balance, gait, and sit to stand
measure: PROMIS Depression Scale
time frame: Pre
description: Measures depression
measure: PROMIS Participation Scale
time frame: Pre
description: Measures daily participation
measure: PROMIS Global Health
time frame: Pre
description: Measures general health
measure: UAB Life-Space Inventory
time frame: Pre
description: Measures places travelled within past month
arm group label: Adapted SAFE Intervention
arm group type: Experimental
description: Adapted version of the SAFE Health Behavior and Exercise intervention.
arm group label: Original SAFE Intervention
arm group type: Active Comparator
description: Original version of the SAFE intervention.
intervention type: Behavioral
intervention name: Original SAFE Intervention
description: A CDC recommended, evidence-based falls prevention intervention.
arm group label: Original SAFE Intervention
intervention type: Behavioral
intervention name: Adapted SAFE Intervention
description: An adapted version of the SAFE intervention meant to target older adults with low vision.
arm group label: Adapted SAFE Intervention
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cynthia Brown, MD, MSPH
role: Principal Investigator
affiliation: Birmingham VA and UAB School of Medicine
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Sarah Blaylock
investigator title: Doctoral Candidate Department of Occupational Therapy
mesh term: Vision, Low
sharing ipd: No
ipd description: All data serves to fulfill dissertation requirement and will not be shared with additional researchers.