Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder

Overactive Bladder Clinical Trial

— OAB  

Official title:

Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251054
• Other study ID #: WS624459
• Status: Completed
• Phase: N/A
• First received: September 24, 2014
• Last updated: September 24, 2014
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: September 2014
• Source: Miami VA Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Other:
• 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.
• 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 without Avatars.

Locations

Country	Name	City	State
United States	Miami VA Healthcare System	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Miami VA Healthcare System	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No