<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/NCT04464928</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00020462</org_study_id>
    <nct_id>NCT04464928</nct_id>
  </id_info>
  <brief_title>Pacific Northwest Female Urinary Incontinence Treatment Digital Awareness Project</brief_title>
  <acronym>PNW-IP</acronym>
  <official_title>Using Digital Media to Increase Population Knowledge of Urinary Incontinence Treatment Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</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 investigators will compare whether advertisements on Google or Facebook are more&#xD;
      effective to reach women in the Pacific Northwest about treatment options for urinary&#xD;
      incontinence through the American Urogynecologic Society's patient education website,&#xD;
      VoicesForPFD.org. The investigators hypothesize there is no difference in the overall&#xD;
      population engagement between these two platforms due to anticipated higher reach through&#xD;
      Facebook based on user characteristics but higher engagement through Google due to higher&#xD;
      user interest on this platform.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a comparative ecological study to compare effectiveness of two&#xD;
      different targeted digital outreach platforms to engage women at risk for urinary&#xD;
      incontinence in the Pacific Northwest. Counties in Oregon, Washington, Idaho will be&#xD;
      randomized to receive advertisements for the American Urogynecologic Society's patient&#xD;
      education website (domain VoicesForPFD.org) via either Google or Facebook. The investigators&#xD;
      will use advertising campaigns developed specifically for this purpose. Through website&#xD;
      analytics measuring advertisement clicks and census population data, the investigators will&#xD;
      estimate utilization rates of the website for each county among the target population of&#xD;
      middle-aged women to determine if one platform is more effective than the other for this&#xD;
      topic and population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2020</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Population website engagement</measure>
    <time_frame>Through study completion, up to 4 months in duration from the start of advertising</time_frame>
    <description>Number of website visits per capita through study advertisements.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impressions due to advertisements</measure>
    <time_frame>Through study completion, up to 4 months in duration from the start of advertising</time_frame>
    <description>Number of advertisement views per capita of the study advertisements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Website users due to advertisements</measure>
    <time_frame>Through study completion, up to 4 months in duration from the start of advertising</time_frame>
    <description>Number of new users per capita coming to the VoicesForPFD.org website through study advertisements.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">119</enrollment>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>User interests</arm_group_label>
    <description>Facebook advertisements arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>User characteristics</arm_group_label>
    <description>Google advertisements arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Facebook Advertisements</intervention_name>
    <description>Counties will receive advertisements to VoicesForPFD.org's webpage on urinary incontinence on Facebook Ads when triggered by user characteristics indicating elevated risk of female urinary incontinence.</description>
    <arm_group_label>User interests</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Google Advertisements</intervention_name>
    <description>Counties will receive advertisements to VoicesForPFD.org's webpage on urinary incontinence on Google Ads when triggered by keywords relevant to female urinary incontinence.</description>
    <arm_group_label>User characteristics</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All internet users in all counties in Oregon, Washington, and Idaho will be eligible to see&#xD;
        advertisements.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Internet user in Idaho, Oregon, or Washington states&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Identified geographic location outside Idaho, Oregon, or Washington states&#xD;
&#xD;
          -  Users identified by the advertising platforms as male.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Non-male users will be targeted based on their gender identification in each platform</gender_description>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>W Gregory, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>W. Thomas Gregory</investigator_full_name>
    <investigator_title>Professor of Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <keyword>female</keyword>
  <keyword>advertising</keyword>
  <keyword>urinary incontinence</keyword>
  <keyword>social media</keyword>
  <keyword>search engine</keyword>
  <keyword>internet</keyword>
  <keyword>quality of life</keyword>
  <keyword>feasibility studies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual participant data will be collected as part of the study.</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/NCT04464928
org study id: STUDY00020462
nct id: NCT04464928
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators will compare whether advertisements on Google or Facebook are more
      effective to reach women in the Pacific Northwest about treatment options for urinary
      incontinence through the American Urogynecologic Society's patient education website,
      VoicesForPFD.org. The investigators hypothesize there is no difference in the overall
      population engagement between these two platforms due to anticipated higher reach through
      Facebook based on user characteristics but higher engagement through Google due to higher
      user interest on this platform.
The investigators will conduct a comparative ecological study to compare effectiveness of two
      different targeted digital outreach platforms to engage women at risk for urinary
      incontinence in the Pacific Northwest. Counties in Oregon, Washington, Idaho will be
      randomized to receive advertisements for the American Urogynecologic Society's patient
      education website (domain VoicesForPFD.org) via either Google or Facebook. The investigators
      will use advertising campaigns developed specifically for this purpose. Through website
      analytics measuring advertisement clicks and census population data, the investigators will
      estimate utilization rates of the website for each county among the target population of
      middle-aged women to determine if one platform is more effective than the other for this
      topic and population.
observational model: Ecologic or Community
time perspective: Prospective
measure: Population website engagement
time frame: Through study completion, up to 4 months in duration from the start of advertising
description: Number of website visits per capita through study advertisements.
measure: Impressions due to advertisements
time frame: Through study completion, up to 4 months in duration from the start of advertising
description: Number of advertisement views per capita of the study advertisements.
measure: Website users due to advertisements
time frame: Through study completion, up to 4 months in duration from the start of advertising
description: Number of new users per capita coming to the VoicesForPFD.org website through study advertisements.
arm group label: User interests
description: Facebook advertisements arm
arm group label: User characteristics
description: Google advertisements arm
intervention type: Other
intervention name: Facebook Advertisements
description: Counties will receive advertisements to VoicesForPFD.org's webpage on urinary incontinence on Facebook Ads when triggered by user characteristics indicating elevated risk of female urinary incontinence.
arm group label: User interests
intervention type: Other
intervention name: Google Advertisements
description: Counties will receive advertisements to VoicesForPFD.org's webpage on urinary incontinence on Google Ads when triggered by keywords relevant to female urinary incontinence.
arm group label: User characteristics
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Non-male users will be targeted based on their gender identification in each platform
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: W Gregory, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: W. Thomas Gregory
investigator title: Professor of Obstetrics and Gynecology
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No
ipd description: No individual participant data will be collected as part of the study.