Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder

NCT ID: NCT02251054

Last Updated: 2014-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-31

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

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Avatar group

Intervention group viewed two avatar coaches: a generic avatar coach (GAC) and a self-avatar, "peer" mentor (SAP).

Group Type EXPERIMENTAL

Avatar group

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

No Avatar group

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

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
Minimum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Miami VA Healthcare System

FED

Sponsor Role lead

Responsible Party

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Allen D. Andrade

Staff physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allen D Andrade, MD

Role: PRINCIPAL_INVESTIGATOR

Miami VAHS

Locations

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Miami VA Healthcare System

Miami, Florida, United States

Site Status

Countries

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United States

References

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Andrade AD, Anam R, Karanam C, Downey P, Ruiz JG. An overactive bladder online self-management program with embedded avatars: a randomized controlled trial of efficacy. Urology. 2015 Mar;85(3):561-7. doi: 10.1016/j.urology.2014.11.017. Epub 2015 Jan 10.

Reference Type DERIVED
PMID: 25586473 (View on PubMed)

Other Identifiers

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WS624459

Identifier Type: -

Identifier Source: org_study_id

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