An interventional study of Avatar group and No Avatar group in Overactive Bladder, sponsored by Miami VA Healthcare System. Completed at 1 site in United States. Open to female participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2014-09-26.
Sponsored by Miami VA Healthcare System · Not applicable and Interventional
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
864 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.
This study's enrollment of 47 is below the median of 70 across 660 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Miami VA Healthcare System is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Intervention group viewed two avatar coaches: a generic avatar coach (GAC) and a self-avatar, "peer" mentor (SAP).
Other: 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.
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 with Avatars.
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.
Overactive bladder- health related quality of life (OAB HRQOL)
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.
Time frame: Baseline and at one, six, and 12 weeks
Perception of Bladder Condition (PPBC)
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
Time frame: Baseline and at one, six, and 12 weeks
Overactive bladder symptoms
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.
Time frame: 12 weeks duration
Geriatric Self-Efficacy Index for Urinary Incontinence (GSEI)
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."
Time frame: Baseline and at one, six, and 12 weeks
Adherence to Pelvic Floor Muscle Exercises (PFMEs)
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).
Time frame: Baseline and at one, six, and 12 weeks
Avatar Recognition
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?"
Time frame: At 12 weeks
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Miami VA Healthcare System