<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/NCT03255161</url>
  </required_header>
  <id_info>
    <org_study_id>UArizona1</org_study_id>
    <secondary_id>R33DC013681</secondary_id>
    <nct_id>NCT03255161</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial of a Community Health Worker Program on Hearing Loss (Oyendo Bien)</brief_title>
  <official_title>Oyendo Bien: Reducing Disparities in Access to Hearing Health Care on the U.S.-Mexico Border</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Deafness and Other Communication Disorders (NIDCD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Arizona</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 study is to test the effectiveness of a community health worker&#xD;
      intervention to expand access to hearing health care among older adults facing health&#xD;
      disparities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 19, 2015</start_date>
  <completion_date type="Anticipated">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 23, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean frequency of communication strategy use as measured at eight weeks post baseline for each of a series of study-specific strategies taught in the intervention</measure>
    <time_frame>8 weeks</time_frame>
    <description>Participants rate the frequency of use of each communication strategy on a five-point Likert scale. Communication strategies include such things as discussing hearing loss, talking face-to-face, and speaking slowly and clearly.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean number of hearing health actions taken and number of people who took each hearing health action at eight weeks post baseline</measure>
    <time_frame>8 weeks</time_frame>
    <description>Questionnaire includes 7 possible actions for managing hearing health or accessing hearing health care services (discussed with family, discussed with doctor, discussed with specialist, had a hearing test, used an assistive device, used a hearing aid, used hearing protection).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mean value for hearing-specific health-related quality of life at eight weeks post baseline as measured by a series of study-specific questions, some of which are adapted from the Self Assessment of Communication</measure>
    <time_frame>8 weeks</time_frame>
    <description>Participants rate the impact of hearing loss on various aspects of their lives, such as their emotional state and enjoyment of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Communication function with partner: Mean frequency and severity of communication-related challenges as measured by a series of study-specific questions at eight weeks post baseline</measure>
    <time_frame>8 weeks</time_frame>
    <description>Frequency and difficulty of communication-related challenges resulting from hearing loss.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean confidence in communication management at eight weeks post baseline as measured by a series of study-specific questions</measure>
    <time_frame>8 weeks</time_frame>
    <description>Participants rate their confidence in being able to manage their hearing loss and communication with family and other communication partners.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Hearing Loss</condition>
  <arm_group>
    <arm_group_label>Immediate communication education and support group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>community health worker-audiologist communication education and support group</intervention_name>
    <description>A 5-week educational program on hearing loss, communication strategies, and peer support facilitated by community health workers supervised by an audiologist.</description>
    <arm_group_label>Immediate communication education and support group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Minimum age: 50 years&#xD;
&#xD;
          -  Audiometrically-confirmed hearing loss&#xD;
&#xD;
          -  Availability of a communication partner to attend the program with the participant&#xD;
&#xD;
          -  Be Spanish speaking and able to sign written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole Marrone, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Arizona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mariposa Community Health Center</name>
      <address>
        <city>Nogales</city>
        <state>Arizona</state>
        <zip>85621-1063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>October 3, 2019</last_update_submitted>
  <last_update_submitted_qc>October 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hearing Loss</mesh_term>
    <mesh_term>Deafness</mesh_term>
  </condition_browse>
  <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/NCT03255161
org study id: UArizona1
secondary id: R33DC013681
nct id: NCT03255161
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to test the effectiveness of a community health worker
      intervention to expand access to hearing health care among older adults facing health
      disparities.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Single (Investigator)
measure: Mean frequency of communication strategy use as measured at eight weeks post baseline for each of a series of study-specific strategies taught in the intervention
time frame: 8 weeks
description: Participants rate the frequency of use of each communication strategy on a five-point Likert scale. Communication strategies include such things as discussing hearing loss, talking face-to-face, and speaking slowly and clearly.
measure: Mean number of hearing health actions taken and number of people who took each hearing health action at eight weeks post baseline
time frame: 8 weeks
description: Questionnaire includes 7 possible actions for managing hearing health or accessing hearing health care services (discussed with family, discussed with doctor, discussed with specialist, had a hearing test, used an assistive device, used a hearing aid, used hearing protection).
measure: Mean value for hearing-specific health-related quality of life at eight weeks post baseline as measured by a series of study-specific questions, some of which are adapted from the Self Assessment of Communication
time frame: 8 weeks
description: Participants rate the impact of hearing loss on various aspects of their lives, such as their emotional state and enjoyment of life.
measure: Communication function with partner: Mean frequency and severity of communication-related challenges as measured by a series of study-specific questions at eight weeks post baseline
time frame: 8 weeks
description: Frequency and difficulty of communication-related challenges resulting from hearing loss.
measure: Mean confidence in communication management at eight weeks post baseline as measured by a series of study-specific questions
time frame: 8 weeks
description: Participants rate their confidence in being able to manage their hearing loss and communication with family and other communication partners.
arm group label: Immediate communication education and support group
arm group type: Experimental
arm group label: Waitlist
arm group type: No Intervention
intervention type: Behavioral
intervention name: community health worker-audiologist communication education and support group
description: A 5-week educational program on hearing loss, communication strategies, and peer support facilitated by community health workers supervised by an audiologist.
arm group label: Immediate communication education and support group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nicole Marrone, PhD
role: Principal Investigator
affiliation: University of Arizona
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hearing Loss
mesh term: Deafness
sharing ipd: No