Virtual Avatar Coaches for Behavioral Therapy of Patients With Overactive Bladder

NCT02251054 | Completed DMC

• 1 other identifier: WS624459
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Overactive Bladder

Keywords

Overactive Bladder; Multimedia; Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Perception of Bladder Condition (PPBC)

  Baseline and at one, six, and 12 weeks

• Overactive bladder symptoms

  12 weeks duration

• Geriatric Self-Efficacy Index for Urinary Incontinence (GSEI)

  Baseline and at one, six, and 12 weeks

• Adherence to Pelvic Floor Muscle Exercises (PFMEs)

  Baseline and at one, six, and 12 weeks

• Avatar Recognition

  At 12 weeks

Study Arms (2)

Avatar group

EXPERIMENTAL

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

Other: Avatar group

No Avatar group

ACTIVE COMPARATOR

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

Interventions

Avatar group 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.

Avatar group

No Avatar group 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.

No Avatar group

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• hematuria
• abdominal pain
• fever
• cognitive impairment (Mini-Cog \< 3)
• positive screen for depression (PHQ2 \> 3)
• hearing issues
• uncorrected visual difficulties

Sponsors & Collaborators

• Miami VA Healthcare System: lead
• Pfizer: collaborator

Study Sites (1)

Miami VA Healthcare System

Miami, Florida, 33125, United States

Location

Related Publications (1)

• 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.

  PMID: 25586473 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Allen D Andrade, MD

  Miami VAHS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff physician

Study Record Dates

• First Submitted: September 24, 2014
• First Posted: September 26, 2014
• Study Start: October 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: October 1, 2013
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

US (1)