Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Overactive bladder- health related quality of life (OAB HRQOL)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •hematuria
- •abdominal pain
- •cognitive impairment (Mini-Cog < 3)
- •positive screen for depression (PHQ2 > 3)
- •hearing issues
- •uncorrected visual difficulties
结局指标
主要结局
Overactive bladder- health related quality of life (OAB HRQOL)
时间窗: Baseline and at one, six, and 12 weeks
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.
次要结局
- Overactive bladder symptoms(12 weeks duration)
- Adherence to Pelvic Floor Muscle Exercises (PFMEs)(Baseline and at one, six, and 12 weeks)
- Avatar Recognition(At 12 weeks)
- Perception of Bladder Condition (PPBC)(Baseline and at one, six, and 12 weeks)
- Geriatric Self-Efficacy Index for Urinary Incontinence (GSEI)(Baseline and at one, six, and 12 weeks)
研究者
Allen D. Andrade
Staff physician
Miami VA Healthcare System