<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/NCT02197533</url>
  </required_header>
  <id_info>
    <org_study_id>14-213</org_study_id>
    <nct_id>NCT02197533</nct_id>
  </id_info>
  <brief_title>Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions</brief_title>
  <official_title>Educating Patients on Management of Overactive Bladder: Written Versus Verbal Instructions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Overactive bladder (OAB) is a common condition among postmenopausal women,&#xD;
      requiring a multifaceted treatment approach that requires patient retention of information&#xD;
      given to them in clinic. Recall of recommendations is a key component of compliance.&#xD;
      Supplemental educational tools such as handouts and audiovisual information have been&#xD;
      investigated for their ability to improve patients' recall of information and increase&#xD;
      satisfaction with the clinical encounter.&#xD;
&#xD;
      Objective: To determine if a written list of seven management strategies for overactive&#xD;
      bladder leads to improved immediate and delayed recall of these recommendations in&#xD;
      postmenopausal women presenting with OAB compared to a traditional verbal discussion.&#xD;
&#xD;
      Methods: In this single-blind, randomized controlled trial, patients' immediate and delayed&#xD;
      (2-week) recall of seven OAB management strategies will be compared between two groups. The&#xD;
      intervention group will receive a handwritten list during their verbal discussion of OAB&#xD;
      treatment while the control group will receive standard care (verbal discussion only).&#xD;
      Immediate and delayed recall will be assessed by a member of the study team who has been&#xD;
      blinded to participants' group assignments.&#xD;
&#xD;
      Results: The results of this study may guide clinicians in the most effective mode of&#xD;
      providing treatment recommendations to post-menopausal patients with OAB.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recall</measure>
    <time_frame>0 and 2 weeks</time_frame>
    <description>Mean number of treatment strategies recalled (scored out of seven) immediately and two weeks after the clinic appointment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>Written list</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the intervention group will receive both verbal information and a written supplement (Appendix 1), produced during the discussion by CM or a fellow (not the individual who obtained consent), on treatment recommendations for OAB. They will leave clinic with this written list of recommendations and will be able to take it home with them.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control group will receive the same verbal information on the treatment recommendations for OAB, however, these patients will not receive the written list of management strategies for their condition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Written List</intervention_name>
    <description>Written list of seven management strategies for OAB to be produced during verbal discussion about management.</description>
    <arm_group_label>Written list</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New diagnosis of overactive bladder&#xD;
&#xD;
          -  post-menopausal&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-existing diagnosis of dementia or other cognitive disorders&#xD;
&#xD;
          -  Patients with mixed incontinence&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Patients with contraindications to taking vaginal estrogen or anticholinergic&#xD;
             medications&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colleen McDermott, MD, MSc, FRSCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>December 3, 2019</last_update_submitted>
  <last_update_submitted_qc>December 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 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>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <!-- 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/NCT02197533
org study id: 14-213
nct id: NCT02197533
lead sponsor: 
has dmc: No
Background: Overactive bladder (OAB) is a common condition among postmenopausal women,
      requiring a multifaceted treatment approach that requires patient retention of information
      given to them in clinic. Recall of recommendations is a key component of compliance.
      Supplemental educational tools such as handouts and audiovisual information have been
      investigated for their ability to improve patients' recall of information and increase
      satisfaction with the clinical encounter.

      Objective: To determine if a written list of seven management strategies for overactive
      bladder leads to improved immediate and delayed recall of these recommendations in
      postmenopausal women presenting with OAB compared to a traditional verbal discussion.

      Methods: In this single-blind, randomized controlled trial, patients' immediate and delayed
      (2-week) recall of seven OAB management strategies will be compared between two groups. The
      intervention group will receive a handwritten list during their verbal discussion of OAB
      treatment while the control group will receive standard care (verbal discussion only).
      Immediate and delayed recall will be assessed by a member of the study team who has been
      blinded to participants' group assignments.

      Results: The results of this study may guide clinicians in the most effective mode of
      providing treatment recommendations to post-menopausal patients with OAB.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Recall
time frame: 0 and 2 weeks
description: Mean number of treatment strategies recalled (scored out of seven) immediately and two weeks after the clinic appointment.
arm group label: Written list
arm group type: Experimental
description: Patients in the intervention group will receive both verbal information and a written supplement (Appendix 1), produced during the discussion by CM or a fellow (not the individual who obtained consent), on treatment recommendations for OAB. They will leave clinic with this written list of recommendations and will be able to take it home with them.
arm group label: Control
arm group type: No Intervention
description: Patients in the control group will receive the same verbal information on the treatment recommendations for OAB, however, these patients will not receive the written list of management strategies for their condition.
intervention type: Other
intervention name: Written List
description: Written list of seven management strategies for OAB to be produced during verbal discussion about management.
arm group label: Written list
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Colleen McDermott, MD, MSc, FRSCS
role: Principal Investigator
affiliation: Unity Health Toronto
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive