<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/NCT02251054</url>
  </required_header>
  <id_info>
    <org_study_id>WS624459</org_study_id>
    <nct_id>NCT02251054</nct_id>
  </id_info>
  <brief_title>Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder</brief_title>
  <acronym>OAB</acronym>
  <official_title>Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miami VA Healthcare System</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Miami VA Healthcare System</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares the efficacy of embedding avatars into an online self-management program&#xD;
      that teaches OAB behavioral therapy on OAB-related quality of life, symptoms, self-efficacy,&#xD;
      and adherence versus the same program without avatars&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</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>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overactive bladder- health related quality of life (OAB HRQOL)</measure>
    <time_frame>Baseline and at one, six, and 12 weeks</time_frame>
    <description>The OAB-q is a 33-item measure to assess impact of OAB symptoms on HRQOL. The OAB-q consists of a symptom bother scale and four HRQOL subscales (coping, concern, sleep, and social interaction). All scale scores are transformed to a 0-to-100-point scale, with higher symptom bother scores indicating greater symptom severity, and lower total and subscale scores indicating improvement in HRQOL.27 A 10-point change in these scales indicates a minimal clinically important difference (MCID). The Cronbach alpha coefficient in this study was 0.88.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perception of Bladder Condition (PPBC)</measure>
    <time_frame>Baseline and at one, six, and 12 weeks</time_frame>
    <description>The PPBC is a single-item, six-point rating scale of participants subjective assessment of their bladder symptoms, with the question &quot;My bladder causes…&quot; me no (1), very minor (2), minor (3), moderate (4), severe (5), or many severe (6) problems. A two-point negative change indicates an MCID.28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overactive bladder symptoms</measure>
    <time_frame>12 weeks duration</time_frame>
    <description>Participants completed daily bladder diaries data for 12 weeks with information on date, beverage, quantity and time of fluid intake, voiding frequency, voiding volume quantified, urge-related episodes with or without urinary incontinence, and the circumstances of each episode. At each visit, research associates would review bladder diaries to ensure that entries were clear and interpretable. A research associate, blinded to group assignment, scored bladder diaries and managed the data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geriatric Self-Efficacy Index for Urinary Incontinence (GSEI)</measure>
    <time_frame>Baseline and at one, six, and 12 weeks</time_frame>
    <description>The GSEI measures older adults' level of confidence in preventing incontinence episodes. Total scores for the GSEI were computed by summing the scores from each of the 16 items (minimum 0, maximum 10 points per item, range 0-160); a minimum 20-point difference suggests an MCID. The Cronbach alpha coefficient in this study was 0.91.29 We also asked participants at baseline and at one, six, and 12 weeks to describe their confidence in doing pelvic floor muscle exercises: &quot;How confident are you in doing pelvic floor muscle exercises?&quot; and their ability to suppress urge: &quot;How confident are you in suppressing the urge?&quot; on a 100 mm visual analog scales (VAS). The 100 mm VAS was in the range of 0, &quot;not at all confident&quot; to 10, &quot;extremely confident.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to Pelvic Floor Muscle Exercises (PFMEs)</measure>
    <time_frame>Baseline and at one, six, and 12 weeks</time_frame>
    <description>Participants were asked how often they had performed PFME in the previous week (0=do not perform, 1=once a week, 2=twice a week once a day, 3=twice a week more than once a day, 4=alternate days once a day, 5= alternate day more than once, 6=every day of the week once a day, 7=every day of the week more than once a day). We also asked about the number of repetitions they did during each exercise session (0=1-2 times, 1=2-4 times, 3=4-6 times, 4=6-8 times, 5=8-10 times, 6=more than 10 times).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Avatar Recognition</measure>
    <time_frame>At 12 weeks</time_frame>
    <description>The research associate asked participants if they recognized the face of the avatars in the tutorials at 12 weeks with a single question: &quot;Who did the avatar look like?&quot;</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>Avatar group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group viewed two avatar coaches: a generic avatar coach (GAC) and a self-avatar, &quot;peer&quot; mentor (SAP).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Avatar group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group version (voice only) observed the identical program, including introductions, question asking, narration of animations, delivery of key points, and summary of each section with identical pre-recorded voices without the avatars.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Avatar group</intervention_name>
    <description>We developed and tested the online program of three multimedia tutorials using the game development and rendering engine (Unity3D, Unity Technologies, San Francisco, CA). This arm saw the tutorials with Avatars.</description>
    <arm_group_label>Avatar group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Avatar group</intervention_name>
    <description>We developed and tested the online program of three multimedia tutorials using the game development and rendering engine (Unity3D, Unity Technologies, San Francisco, CA). This arm saw the tutorials without Avatars.</description>
    <arm_group_label>No Avatar group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 55 or older&#xD;
&#xD;
          -  women living in the community&#xD;
&#xD;
          -  who could read and speak English&#xD;
&#xD;
          -  urgency (≥3 episodes/24 hrs.) ± urge urinary incontinence&#xD;
&#xD;
          -  urinary frequency (≥8 times/24 hrs.)&#xD;
&#xD;
          -  nocturia (awakening ≥2 times at night)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  hematuria&#xD;
&#xD;
          -  abdominal pain&#xD;
&#xD;
          -  fever&#xD;
&#xD;
          -  cognitive impairment (Mini-Cog &lt; 3)&#xD;
&#xD;
          -  positive screen for depression (PHQ2 &gt; 3)&#xD;
&#xD;
          -  hearing issues&#xD;
&#xD;
          -  uncorrected visual difficulties&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allen D Andrade, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Miami VAHS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Miami VA Healthcare System</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>September 24, 2014</last_update_submitted>
  <last_update_submitted_qc>September 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Miami VA Healthcare System</investigator_affiliation>
    <investigator_full_name>Allen D. Andrade</investigator_full_name>
    <investigator_title>Staff physician</investigator_title>
  </responsible_party>
  <keyword>Overactive Bladder</keyword>
  <keyword>Multimedia</keyword>
  <keyword>Behavioral Therapy</keyword>
  <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/NCT02251054
org study id: WS624459
nct id: NCT02251054
lead sponsor: 
collaborator: 
has dmc: Yes
This study compares the efficacy of embedding avatars into an online self-management program
      that teaches OAB behavioral therapy on OAB-related quality of life, symptoms, self-efficacy,
      and adherence versus the same program without avatars
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Outcomes Assessor)
measure: Overactive bladder- health related quality of life (OAB HRQOL)
time frame: Baseline and at one, six, and 12 weeks
description: The OAB-q is a 33-item measure to assess impact of OAB symptoms on HRQOL. The OAB-q consists of a symptom bother scale and four HRQOL subscales (coping, concern, sleep, and social interaction). All scale scores are transformed to a 0-to-100-point scale, with higher symptom bother scores indicating greater symptom severity, and lower total and subscale scores indicating improvement in HRQOL.27 A 10-point change in these scales indicates a minimal clinically important difference (MCID). The Cronbach alpha coefficient in this study was 0.88.
measure: Perception of Bladder Condition (PPBC)
time frame: Baseline and at one, six, and 12 weeks
description: The PPBC is a single-item, six-point rating scale of participants subjective assessment of their bladder symptoms, with the question "My bladder causes…" me no (1), very minor (2), minor (3), moderate (4), severe (5), or many severe (6) problems. A two-point negative change indicates an MCID.28
measure: Overactive bladder symptoms
time frame: 12 weeks duration
description: Participants completed daily bladder diaries data for 12 weeks with information on date, beverage, quantity and time of fluid intake, voiding frequency, voiding volume quantified, urge-related episodes with or without urinary incontinence, and the circumstances of each episode. At each visit, research associates would review bladder diaries to ensure that entries were clear and interpretable. A research associate, blinded to group assignment, scored bladder diaries and managed the data.
measure: Geriatric Self-Efficacy Index for Urinary Incontinence (GSEI)
time frame: Baseline and at one, six, and 12 weeks
description: The GSEI measures older adults' level of confidence in preventing incontinence episodes. Total scores for the GSEI were computed by summing the scores from each of the 16 items (minimum 0, maximum 10 points per item, range 0-160); a minimum 20-point difference suggests an MCID. The Cronbach alpha coefficient in this study was 0.91.29 We also asked participants at baseline and at one, six, and 12 weeks to describe their confidence in doing pelvic floor muscle exercises: "How confident are you in doing pelvic floor muscle exercises?" and their ability to suppress urge: "How confident are you in suppressing the urge?" on a 100 mm visual analog scales (VAS). The 100 mm VAS was in the range of 0, "not at all confident" to 10, "extremely confident."
measure: Adherence to Pelvic Floor Muscle Exercises (PFMEs)
time frame: Baseline and at one, six, and 12 weeks
description: Participants were asked how often they had performed PFME in the previous week (0=do not perform, 1=once a week, 2=twice a week once a day, 3=twice a week more than once a day, 4=alternate days once a day, 5= alternate day more than once, 6=every day of the week once a day, 7=every day of the week more than once a day). We also asked about the number of repetitions they did during each exercise session (0=1-2 times, 1=2-4 times, 3=4-6 times, 4=6-8 times, 5=8-10 times, 6=more than 10 times).
measure: Avatar Recognition
time frame: At 12 weeks
description: The research associate asked participants if they recognized the face of the avatars in the tutorials at 12 weeks with a single question: "Who did the avatar look like?"
arm group label: Avatar group
arm group type: Experimental
description: Intervention group viewed two avatar coaches: a generic avatar coach (GAC) and a self-avatar, "peer" mentor (SAP).
arm group label: No Avatar group
arm group type: Active Comparator
description: The control group version (voice only) observed the identical program, including introductions, question asking, narration of animations, delivery of key points, and summary of each section with identical pre-recorded voices without the avatars.
intervention type: Other
intervention name: Avatar group
description: We developed and tested the online program of three multimedia tutorials using the game development and rendering engine (Unity3D, Unity Technologies, San Francisco, CA). This arm saw the tutorials with Avatars.
arm group label: Avatar group
intervention type: Other
intervention name: No Avatar group
description: We developed and tested the online program of three multimedia tutorials using the game development and rendering engine (Unity3D, Unity Technologies, San Francisco, CA). This arm saw the tutorials without Avatars.
arm group label: No Avatar group
criteria: 
gender: Female
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Allen D Andrade, MD
role: Principal Investigator
affiliation: Miami VAHS
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Miami VA Healthcare System
investigator full name: Allen D. Andrade
investigator title: Staff physician
mesh term: Urinary Bladder, Overactive