Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder
NCT02251054
ABOUT THIS STUDY
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- 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)
- hematuria
- abdominal pain
- fever
- cognitive impairment (Mini-Cog < 3)
- positive screen for depression (PHQ2 > 3)
- hearing issues
- uncorrected visual difficulties
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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |