Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder

Study Overview
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Brief Summary
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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

Official Title
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Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder

Conditions
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Overactive Bladder

Intervention / Treatment
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* Other: Avatar group
* Other: No Avatar group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avatar group<br>Intervention group viewed two avatar coaches: a generic avatar coach (GAC) and a self-avatar, peer mentor (SAP). | Other: Avatar group<br>* 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.<br>|
| Active Comparator: No Avatar group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and at one, six, and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | 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). | 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? | At 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder, Multimedia, Behavioral Therapy