Efficacy of Animated Videos to Foster Healthy Bladder Behaviors in Community Women

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-27

Study Completion Date

2024-10-06

Brief Summary

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In daily life, women are exposed to a wide range of challenging situations that can negatively affect toileting management and long-term bladder health. Research shows that women engage in behaviors that may lead to unfavorable consequences, such as a worrying sense of bladder urgency or an awkward moment of urine leakage. The investigators surmise that consciously or unconsciously adopted behaviors influence lifelong bladder health, toileting management, and sense of self-efficacy in this arena. Adoption of research-supported behaviors that foster bladder well-being for women is dependent on women's access to learning multiple healthy behavioral strategies.

Studies on personal woman-centered strategies for toileting management and adoption of behaviors that foster bladder health are scarce in the scientific literature. The investigators have published encouraging results of an in-person study with a clinical sample using accessible and enjoyable videos about research-based bladder health behaviors, invented by the co-investigator of this study, Janis M. Miller.

We now launch an additional study of 90 community-based women of midlife age using an online survey methodology that incorporates sending study participants to the website. The study has two main objectives:

1. To determine baseline bladder health and toileting management behavior profiles in intervention-naïve community-based women as assessed by the Confident Bladder Behavior Questionnaire
2. To determine at post-intervention whether behavioral profiles of the respondents have significantly changed after being randomized into one of three groups: Group 1: who watch the animated explainer videos within the Confident Bladder website that are predominantly related to daytime conditions, Group 2: who watch the Confident Bladder website's animated explainer videos predominantly related to sleep/wake conditions and the additional tips and tricks section, and Group 3: controls who only receive access to the the Confident Bladder website at study's end after post-intervention assessments.

We will test the following hypothesis:

Viewing the Confident Bladder website will demonstrate an effect size at 2-weeks post intervention of greater than 0.5, as determined by comparing number and percentage of research-based behavioral strategies used by the Control group to the number and percentage of strategies used by the two intervention groups who were assigned to view different parts of the website.

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Detailed Description

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Conditions

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Urinary Bladder, Overactive Urinary Incontinence, Urge

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

This online study administered by Qualtrics Research Services randomly allocates study participants to groups. The participants don't know which group until they are assigned after they complete surveys. The group assignments are masked for the investigators and outcomes assessor until after data collection is completed.

Study Groups

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eLearning Daytime

This group completes pre-intervention surveys and then is assigned to view the part of the website that deals with Daytime Hold Confidence. Participants engage in an elearning activity on how to prevent and deal with urinary urges during daytime activities. Participants in the group complete post-intervention surveys immediately after viewing the website and two weeks after study entry.

Group Type EXPERIMENTAL

eLearning

Intervention Type OTHER

Participants in the intervention arms view a website developed by urinary bladder experts that presents information about how to prevent inconvenient urinary urges.

eLearning Sleep/Wake

This group completes pre-intervention surveys and then is assigned to view the part of the website that deals with Sleep/Wake Confidence. Participants engage in an elearning activity on how to prevent and deal with urinary urges that occur after the participant has fallen asleep and then when they arise in the morning. In addition, this group is assigned to the Tips and Tricks, which covers additional information. Participants in the group complete post-intervention surveys immediately after viewing the website and two weeks after study entry.

Group Type EXPERIMENTAL

eLearning

Intervention Type OTHER

Participants in the intervention arms view a website developed by urinary bladder experts that presents information about how to prevent inconvenient urinary urges.

Control Group

This group completes pre-intervention surveys and then immediately completes the post-intervention surveys. Two weeks after study entry they complete the same surveys completed by members of the other two groups.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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eLearning

Participants in the intervention arms view a website developed by urinary bladder experts that presents information about how to prevent inconvenient urinary urges.

Intervention Type OTHER

Other Intervention Names

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eLearning Daytime

Eligibility Criteria

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Inclusion Criteria

* Must have a U.S. IP Address
* Must be female between age of 40 and 64
* Must be enrolled in a Study Participant Panel accessed by Qualtrics
* Must read and speak English