Urinary Bladder, Overactive, Urinary Incontinence, Urge
Conditions
Keywords
Prevention, Learning, Clinical trials, randomized
Brief summary
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.
Interventions
OTHEReLearning
Participants in the intervention arms view a website developed by urinary bladder experts that presents information about how to prevent inconvenient urinary urges.
Sponsors
University of Michigan
Kathleen O'Connell
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 64 Years
Healthy volunteers
Yes
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
Exclusion criteria
* NonEnglish speakers/readers * Does not consent to participate * Does not commit to providing thoughtful and honest answers to the surveys
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Confident Bladder Behavior Questionnaire | All respondents complete this questionnaire during the first session and then two weeks later. Respondents in the experimental arms complete the questionnaire prior to the eLearning activity. | A 31-item questionnaire assessing the extent to which respondents engage in behaviors related to maintaining a healthy bladder. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge about Healthy Bladder Behaviors | All respondents complete this test during the first study session. Those in the experimental arms complete it after they view the website. | A 14-item multiple choice test on the information conveyed in the website. |
| Urinary Cues Questionnaire | All respondents complete this in the first study session and two weeks after the eLearning activity.. Those in the experimental arm complete the Urinary Cues Questionnaire before the eLearning activity. | A 21-item survey assessing the extent to which participants recognize that each cue gives them the urge to urinate. |
| Self-efficacy for Performing Healthy Bladder Behaviors | All respondents complete this in the first study session and two weeks after the eLearning activity.. Those in the experimental arm complete the Self-efficacy Questionnaire after the eLearning activity. | a 12-item survey assessing the respondents' confidence that they can carry out healthy bladder behaviors. |
| Evaluation of the Website and the Study | All respondents complete the Evaluation surveys during the first session only. Those in the Experimental groups complete the Evaluation survey after viewing the website. | For Experimental groups, a 14-item questionnaire assessing the respondents' experience with the website and their intention to follow the advice offered by the website. For Control Group, a 4-item questionnaire assessing the respondents' experience with the study and their intention to view the Confident Bladder website after the study. |
Countries
United States
Outcome results
None listed