Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder (OAB)

September 24, 2014 updated by: Allen D. Andrade, Miami VA Healthcare System
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33125
        • Miami VA Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Avatar group
Intervention group viewed two avatar coaches: a generic avatar coach (GAC) and a self-avatar, "peer" mentor (SAP).
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.
Active Comparator: No 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 without Avatars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overactive bladder- health related quality of life (OAB HRQOL)
Time Frame: 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.
Baseline and at one, six, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of Bladder Condition (PPBC)
Time Frame: Baseline and at one, six, and 12 weeks
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
Time Frame: 12 weeks duration
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)
Time Frame: Baseline and at one, six, and 12 weeks
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)
Time Frame: Baseline and at one, six, and 12 weeks
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
Time Frame: At 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Miami VA Healthcare System

Collaborators

Pfizer

Investigators

  • Principal Investigator: Allen D Andrade, MD, Miami VAHS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

September 26, 2014

Last Update Submitted That Met QC Criteria

September 24, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WS624459

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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