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Trial record 1 of 1 for:    NCT02251054
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Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder (OAB)

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ClinicalTrials.gov Identifier: NCT02251054
Recruitment Status : Completed
First Posted : September 26, 2014
Last Update Posted : September 26, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Allen D. Andrade, Miami VA Healthcare System

Tracking Information
First Submitted Date  ICMJE September 24, 2014
First Posted Date  ICMJE September 26, 2014
Last Update Posted Date September 26, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2014)
Overactive bladder- health related quality of life (OAB HRQOL) [ Time Frame: Baseline and at one, six, and 12 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2014)
  • Perception of Bladder Condition (PPBC) [ Time Frame: Baseline and at one, six, and 12 weeks ]
    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
  • Overactive bladder symptoms [ Time Frame: 12 weeks duration ]
    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.
  • Geriatric Self-Efficacy Index for Urinary Incontinence (GSEI) [ Time Frame: Baseline and at one, six, and 12 weeks ]
    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."
  • Adherence to Pelvic Floor Muscle Exercises (PFMEs) [ Time Frame: Baseline and at one, six, and 12 weeks ]
    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).
  • Avatar Recognition [ Time Frame: At 12 weeks ]
    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?"
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder
Official Title  ICMJE Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder
Brief Summary 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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Condition  ICMJE Overactive Bladder
Intervention  ICMJE
  • Other: Avatar group
    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.
  • Other: No Avatar group
    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.
Study Arms  ICMJE
  • Experimental: Avatar group
    Intervention group viewed two avatar coaches: a generic avatar coach (GAC) and a self-avatar, "peer" mentor (SAP).
    Intervention: Other: Avatar group
  • Active Comparator: No Avatar group
    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: Other: No Avatar group
Publications * Andrade AD, Anam R, Karanam C, Downey P, Ruiz JG. An overactive bladder online self-management program with embedded avatars: a randomized controlled trial of efficacy. Urology. 2015 Mar;85(3):561-7. doi: 10.1016/j.urology.2014.11.017. Epub 2015 Jan 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2014)
47
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age 55 or older
  • women living in the community
  • who could read and speak English
  • urgency (≥3 episodes/24 hrs.) ± urge urinary incontinence
  • urinary frequency (≥8 times/24 hrs.)
  • nocturia (awakening ≥2 times at night)

Exclusion Criteria:

  • hematuria
  • abdominal pain
  • fever
  • cognitive impairment (Mini-Cog < 3)
  • positive screen for depression (PHQ2 > 3)
  • hearing issues
  • uncorrected visual difficulties
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02251054
Other Study ID Numbers  ICMJE WS624459
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allen D. Andrade, Miami VA Healthcare System
Study Sponsor  ICMJE Miami VA Healthcare System
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Allen D Andrade, MD Miami VAHS
PRS Account Miami VA Healthcare System
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP