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Health Knowledge, Attitudes, PracticeBladder BasicsNCT05852353

Impact, Feasibility, and Acceptability of Bladder Basics

A study testing Digital Pediatric Bladder Health Patient Education Curriculum in people with Health Knowledge, Attitudes, Practice, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

PLUTS remains a common childhood condition despite effective treatment options. It is important to improve delivery of UT at the clinical level, with future studies that shift pediatric bladder health into a broader community context. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Health Knowledge, Attitudes, Practice
What is being tested?
Digital Pediatric Bladder Health Patient Education Curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
204 participants
Where
1 siteUnited States
Study dates
22 Aug 2023to 10 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Parents or guardians >= 18 years of age
  • involved in the care of a child 5-10 years old with bladder problems
  • English speaking

Who cannot join

  • Individuals <18 years old.
  • Does not meet inclusion criteria

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Stanford University School of Medicine

    Stanford, California, 94305

Other trials in United States

About this study

Official title: Impact, Feasibility, and Acceptability of a Digital Health Intervention for Healthy Children With Pediatric Lower Urinary Tract Symptoms (pLUTS)

PLUTS remains a common childhood condition despite effective treatment options. It is important to improve delivery of UT at the clinical level, with future studies that shift pediatric bladder health into a broader community context. This change in contextual setting and scale can impact access to care and disease incidence beyond our current treatment paradigms. Therefore, the overall objective is to measure the early impact and feasibility of a digital health intervention, Bladder Basics. To complete this aim, we will measure clinical and education outcomes pre- and post- intervention and our assessment of acceptability and feasibility will consider framework-based barriers to implementation. Since there is limited existing data with which to build a future intervention, these variables have been carefully considered based on requirements for a future school-based intervention.

Read the detailed description

The investigators will use a longitudinal pre-post intervention study design to pilot test the acceptability, feasibility, and preliminary educational and clinical outcomes of a novel digital health intervention, Bladder Basics. The primary outcome was the feasibility of recruiting participants to complete BB, which was assessed through metrics on recruitment, engagement, and rates of post-assessment completion. Secondary outcomes included changes in bladder symptoms (both clinical and subjective improvements), bladder health knowledge, and self-efficacy, guided by social cognitive theory. For this pilot study, no control group will be offered. Benefits of this study design include simplicity and ease of administration. As this intervention is virtual, all screening, consent procedures, and study orientation will be conducted using Zoom. Target recruitment numbers will be weighted towards Q2 and Q3 when children are more likely to be in school. The intervention consists of a 7-video curriculum that can be watched on a tablet device, computer, or phone. The videos will be watched in order at the family's convenience within a 4-week period.

Families can pause and restart the course at any time. Their learning progress will be automatically saved and synced across different devices by the online learning platform. The intervention includes 10 activities that include matching, labeling, and revealing hidden information concepts.

Timed surveys with automatic reminders will be administered and stored via a REDCap database. Pre-intervention surveys will be collected prior to obtaining access to the course and will include baseline demographics, knowledge, DVSS, and self-efficacy measures. After watching each lesson, participants will fill out a post-lesson survey to assess their ability to meet the educational objectives which will count as our short-term knowledge measure. After watching the entire course, participants will have up to 4 weeks from the start of the course to complete the first post-intervention survey. This will include a repeat measure of DVSS and self-efficacy, as well as a new assessment of acceptability, education design, and open-ended feedback questions on perceived structural barriers to adopting bladder health practices and areas for program improvement. A second post-intervention survey will be distributed at 3-months from the start of the course (long-term), and will include a repeat measure of DVSS and knowledge of bladder health practices. The time difference in measuring educational and clinical outcomes reflect the theory that the investigators would expect some degree of time to transpire between knowledge acquisition and repeated practices leading to subjective improvement. Screening, consent, study orientation procedures, and RedCap database management will be managed by a research assistant consistent with prior studies. The investigator will conduct the descriptive and quantitative data analysis portion of the study. Quantitative analysis will be performed using SPSS. The primary investigator will lead overall study completion and address any study-related obstacles or concerns. Alternative approaches include qualitative analysis of open-ended feedback questions using an iterative team-based approach to thematic analysis with myself, 1 research assistant, and 1 medical student who have both been previously trained in this method.

Expected outcomes: The investigators hypothesize that this study will demonstrate that Bladder Basics is a feasible and acceptable program for families facing pLUTS. The investigators expect robust study recruitment based on prior community interest and studies. Information obtained for this study will be used to 1) improve our existing intervention to help families awaiting pLUTS care and 2) design a school-based intervention. Data from this proposal will be submitted for presentation at academic conferences and to relevant journals for manuscript publication.

Being tested
Digital Pediatric Bladder Health Patient Education Curriculum
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Pediatric Bladder Health Patient Education CurriculumOther

    Bladder Basics is designed to be a digital health intervention to improve knowledge of healthy bladder practices. It is a video-based bladder health curriculum based on 1) principles of Urotherapy 2) stakeholder need for a gold-standard resource 3) behavioral change theory 4) education design standards for inclusion as a comprehensive school health program (CSHP).

    The overall mission of the course is to teach children and their families about pediatric bladder health. The development of the course has followed the NIH's Clear \& Simple standards for patient education. The 7 video lesson plan spans 60 minutes total. The course is designed to support families awaiting medical care, which would provide the continued support. In addition, one lesson shares solutions to common home and school-based barriers to behavioral change. The 4 healthy bladder practices that are promoted are- 1) pee every 3 hours 2) drinking water 3) daily poop without straining 4) toilet postures.

Study groups in NCT05852353
Study groupRoleWhat they receive
Single arm longitudinal assessmentExperimentalSingle arm longitudinal assessment of the feasibility of a digital pediatric bladder health patient education curriculum. The intervention consists of 7 videos that can be viewed over a 4-week time period. Impact on the study objectives will be measured using a longitudinal pre-post intervention study design.
Receives: Other: Digital Pediatric Bladder Health Patient Education Curriculum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number and Percentage of Participants Recruited

    Recruitment was measured as the number and percentage of individuals who expressed interest, were screened, and provided consent.

    Measured: 3 months

  2. Engagement: Video Completion Rate

    Engagement was measured by assessing the video completion rate (videos watched/total videos) as calculated by the video platform.

    Measured: 3 months

  3. Post-assessment Completion Rates

    Post-assessment completion was measured as the percentage of participants who completed surveys following the Bladder Basics videos. After completing the videos, participants completed surveys to test knowledge, and collect data regarding user feedback and symptom improvement. The 2 post-intervention surveys were sent at 4-weeks and 12-weeks post-baseline.

    Measured: 4-weeks and 12-weeks

Secondary outcomes (7)
  1. Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes

    To evaluate the impact of Bladder Basics on short- and long-term bladder health clinical outcomes by comparing baseline and post-intervention Dysfunctional Voiding Symptom Score (DVSS) questionnaire results in healthy children ages 5-10 years old with pediatric lower urinary tract symptoms. The survey consists of 10 questions, each scored from 0 to 3 (0 = Almost Never; 1 = Less Than Half the Time; 2 = About Half the Time; 3 = Almost Every Time). Scores were summed to create the overall score (0 to 30). Children with a higher DVSS score have more frequent symptoms and/or behavioral problems

    Measured: baseline, 4-weeks; 12-weeks

  2. Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam

    To evaluate the impact of Bladder Basics on improving knowledge of pediatric bladder health practices by comparing baseline pre-intervention to post-intervention survey results in parents of healthy children ages 5-10 years old with pediatric lower urinary tract symptoms. Knowledge surveys will be created by study team. The survey consists of 11 questions. Correct answers are scored as 1, incorrect answers are scored as 0. Question scores were summed to create an overall score of 0 to 11, with higher scores corresponding to better knowledge about bladder health.

    Measured: Baseline, Post-lesson (approximately 4 weeks) and 12 weeks post-intervention

  3. Validated Self-efficacy Survey

    To measure the acceptability and feasibility of the Bladder Basics education program.

    The self-efficacy survey is adapted from Parents Patient Activation Measure-13 (PPAM-13). Participants answered questions as strongly disagree, disagree, agree, strongly agree, and NA. Raw scores were transformed to an overall scale of 0 to 100. Higher scores indicate higher levels of self-efficacy.

    Measured: Baseline and 4 weeks

  4. Validated Acceptability Survey

    To measure the acceptability and feasibility of the Bladder Basics education program.

    The acceptability survey is developed based on the Technology Acceptance Theory. The survey contains 13 questions assessing perceived usefulness, perceived ease of use, attitude towards intervention, and behavioral intention for future use. Each question is assessed on a 5-point Likert scale, each with a range from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and averaged to create the overall score, with a range of 1 to 5 (higher scores indicate better acceptability).

    Measured: Immediately after completing the videos (up to 4 weeks following baseline)

  5. Validated Education Design Survey -- Parents

    To measure the acceptability and feasibility of the Bladder Basics education program.

    This survey is adapted from the Attention, Relevance, Confidence, and Satisfaction (ARCS) questionnaire. Each question is scored on a 5-point Likert scale ranging from 1 (not true) to 5 (very true). Scores are summed and averaged to create overall score (range: 1 to 5). Higher scores indicate better education design.

    Measured: Immediately after completing the videos (up to 4 weeks following baseline)

  6. Validated Education Design Survey - Children

    To measure the acceptability and feasibility of the Bladder Basics education program.

    This survey is adapted from the Attention, Relevance, Confidence, and Satisfaction (ARCS) questionnaire. Each question is scored on a 5-point Likert scale ranging from 1 (not true) to 5 (very true).

    Measured: Immediately after completing the videos (up to 4 weeks following baseline)

  7. Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program

    Number of excerpted items obtained from participant feedback according to topic area.

    To measure acceptability and feasibility of Bladder Basics with consideration of stakeholder, educational design, and behavioral change theory barriers.

    Open-ended feedback questions were used to characterize the intervention's ability to be used as a population-level intervention. Feedback was coded according to topic area.

    Measured: Immediately after completing the videos (up to 4 weeks following baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2023
  2. Study start22 Aug 2023
  3. Primary completion10 Nov 2024
  4. Study completion10 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Longitudinal Study looking at pre- and post- results of the same group of patients.
Masking
None (open label)
Enrolment
204 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05852353
Sponsor's protocol ID
67807
Other IDs
K12DK137162
Acronym
Bladder Basics
Status last verified
Dec 2025
First submitted
27 Mar 2023
Last updated
19 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to make individual participant data (IPD) available to other researchers.

Publications

  • Liu C, Chu J, Hughes T, Follis C, Kan KM. Empowering Bladder Health Education for Children: Integrating Situated Learning Theory and the ARCS Model in Online Program Design. J Pediatr Health Care. 2026 Jan-Feb;40(1):112-127. doi: 10.1016/j.pedhc.2025.09.005. Epub 2025 Oct 9.

    PubMed 41065601
  • Liu C, Chu J, Kan KM. Effectiveness of an Online Health Education Program for Pediatric Lower Urinary Tract Symptoms. Urology. 2025 Oct;204:171-178. doi: 10.1016/j.urology.2025.05.058. Epub 2025 May 31.

    PubMed 40456454

Questions about this trial

What is this clinical trial studying?

A study testing Digital Pediatric Bladder Health Patient Education Curriculum in people with Health Knowledge, Attitudes, Practice, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and Percentage of Participants Recruited (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05852353, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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