Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder

NCT02251054

Last updated date
Study Location
Miami VA Healthcare System
Miami, Florida, 33125, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
55 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- hematuria


- abdominal pain


- fever


- cognitive impairment (Mini-Cog < 3)


- positive screen for depression (PHQ2 > 3)


- hearing issues


- uncorrected visual difficulties

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Advanced Information
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, MDMiami 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