Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder

Miami VA Healthcare System47 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Overactive Bladder

Interventions

Avatar groupOTHER

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.

No Avatar groupOTHER

Eligibility

Sex: FEMALEMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Miami VA Healthcare System

Miami, Florida, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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."

Data from ClinicalTrials.gov

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