Digital Bladder Health Education for Improving Children's Health Literacy

(Bladder Basics Trial)

Overseen By Chenxi Liu, MEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Under 18, Does not meet criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a digital education program called Bladder Basics, designed to help children with bladder issues. The program focuses on teaching kids and their caregivers about bladder health through seven videos over four weeks. Researchers will assess the program's effectiveness and its potential for easy implementation in schools. This trial suits parents or guardians of English-speaking children aged 5 to 10 with bladder problems. As an unphased trial, it offers families a unique opportunity to contribute to innovative educational solutions for children's bladder health.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this digital health intervention is safe for children?

Research has shown that digital health education programs, such as the Digital Pediatric Bladder Health Patient Education Curriculum, are generally safe. However, specific safety data for this exact program is not available. Studies on digital tools for managing children's urinary incontinence suggest they effectively teach and manage these conditions without known harmful effects. Since this program uses educational videos, it is unlikely to cause physical harm. The main goal is to teach healthy bladder habits, so the content must be clear and engaging for kids. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the digital pediatric bladder health patient education curriculum because it offers a fresh and engaging way to improve children's understanding of bladder health. Unlike traditional methods that might involve pamphlets or in-person consultations, this digital approach uses seven videos that kids can watch at their own pace over four weeks. This method not only makes learning about bladder health more interactive and accessible but also has the potential to reach a wider audience, including those who might not have easy access to healthcare professionals. By improving health literacy in a fun and flexible way, this curriculum could empower children to take better care of their bladder health from an early age.

What evidence suggests that this digital education curriculum is effective for improving children's bladder health literacy?

Research has shown that the Digital Pediatric Bladder Health Patient Education Curriculum improves bladder health in children. In one study, children's symptoms improved by 32% after four weeks and by 42% after twelve weeks. Additionally, 39% of children with bladder issues showed improvements. Parents also noticed significant changes, with 85% and 93% reporting better symptoms at four and twelve weeks, respectively. Furthermore, the percentage of parents who felt their child no longer needed clinic visits rose from 45% to 69% after four weeks. Overall, the program is well-received and encourages active participation. ^{2 6 7 8 9}

Who Is on the Research Team?

Kathleen Kan, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for parents or guardians over 18 years old who take care of a child aged 5-10 with bladder issues and can communicate in English. It's not open to those under 18 or anyone not responsible for a child with these health concerns.

Inclusion Criteria

English speaking

I am over 18 and care for a child aged 5-10 with bladder issues.

Exclusion Criteria

Does not meet inclusion criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Virtual screening via Zoom

Intervention

Participants engage with the Bladder Basics digital health intervention, consisting of a 7-video curriculum and 10 activities over a 4-week period.

4 weeks

Self-paced virtual engagement

Short-term Follow-up

Participants complete a post-intervention survey to assess short-term knowledge and clinical outcomes.

4 weeks

Virtual survey completion

Long-term Follow-up

Participants complete a second post-intervention survey at 3 months to assess long-term knowledge retention and clinical outcomes.

3 months

Virtual survey completion

What Are the Treatments Tested in This Trial?

Interventions

• Digital Pediatric Bladder Health Patient Education Curriculum

Trial Overview The study is testing 'Bladder Basics,' a digital education program aimed at improving pediatric bladder health. The impact and ease of use will be evaluated by comparing clinical outcomes and educational measures before and after the program.

How Is the Trial Designed?

Group I: Single arm longitudinal assessment Experimental Treatment 1 Intervention

Single 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

This study aims to assess the frequency and types of adverse events in Australian pediatric care by reviewing 6000-8000 medical records of children under 16 years from various healthcare settings during 2012 and 2013.

The research will utilize a modified version of the Global Trigger Tool for data collection, which is a systematic approach to identifying potential safety issues in healthcare, highlighting the importance of improving patient safety in children's healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CareTrack Kids-part 3. Adverse events in children's healthcare in Australia: study protocol for a retrospective medical record review. Hibbert, PD., Hallahan, AR., Muething, SE., et al.[2019]

Adverse events occurred in 1% of pediatric hospitalizations, with 0.6% being preventable, indicating that a significant number of children experience harm due to medical management rather than their underlying conditions.

The most common types of preventable adverse events were birth-related (32.2%) and diagnostic-related (30.4%), highlighting the need for targeted research and interventions in these areas to improve patient safety in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events and preventable adverse events in children. Woods, D., Thomas, E., Holl, J., et al.[2007]

Out of 9,000 patient safety reports analyzed from 2012 to 2017, 36% identified usability issues related to electronic health records (EHRs) that contributed to medication events, highlighting significant safety concerns in pediatric care.

Among the usability issues, the most frequent problems were related to system feedback and visual display, with improper dosing being the most common medication error, indicating critical areas for improvement in EHR design to enhance safety for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Electronic Health Record Usability And Safety Challenges In Pediatric Settings. Ratwani, RM., Savage, E., Will, A., et al.[2019]

A scoping review of 388 studies from 1991 to 2012 revealed that children are particularly vulnerable to patient safety issues, with medication errors being the most common concern, identified in 48.7% of the studies.

The review highlighted the need for improved definitions and consistency in patient safety research to better compare and analyze results, emphasizing the importance of addressing both healthcare systems and caregiver perspectives in enhancing safety for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe Care for Pediatric Patients: A Scoping Review Across Multiple Health Care Settings. Stang, A., Thomson, D., Hartling, L., et al.[2017]

A review of 20 studies in pediatric otolaryngology revealed that much of the educational material is written at a reading level too high for effective public health communication, which may hinder understanding.

Parents often struggle to recall information provided during informed consent, but incorporating visual and multimodal elements into education significantly enhances their comprehension and retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health literacy in pediatric otolaryngology: A scoping review. Aaronson, NL., Joshua, CL., Boss, EF.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40456454/

Effectiveness of an Online Health Education Program for ... Symptom scores improved significantly: 32% at 4 weeks and 42% at 12 weeks. Of children initially screening positive for bladder symptoms, 39% ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0891524525002676

Integrating Situated Learning Theory and the ARCS Model ... Bladder Basics was well-accepted and demonstrated high motivational appeal. Participants reported positive attitudes, strong engagement, and ...

3. goldjournal.net goldjournal.net/article/S0090-4295(25)00518-7/abstract

Effectiveness of an Online Health Education Program for ... 85% and 93% of parents reported child symptom improvements at 4 and 12 weeks. Parents reporting no need for clinic visits increased from 45% to 69% at 4 weeks.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05852353

Impact, Feasibility, and Acceptability of Bladder Basics Single arm longitudinal assessment of the feasibility of a digital pediatric bladder health patient education curriculum. The intervention consists of 7 videos ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12089871/

Innovative, Technology-Driven, Digital Tools for Managing ... This scoping review aimed to identify and map innovative, technology-driven, digital tools for managing pediatric urinary incontinence.

6. withpower.com withpower.com/trial/digital-bladder-health-education-for-improving-childrens-health-literacy-8a103

Digital Bladder Health Education for Improving Children's ... Is the Digital Bladder Health Education program safe for children? There is no specific safety data available for the Digital Bladder Health Education program, ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/josh.13456

Parental Knowledge, Beliefs, Practices, and Barriers ... We propose that a bladder health education curriculum include content on (1) healthy bladder behaviors (ie, timed voiding, toileting behaviors ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1477513123000712

“We the BE”: An educational mobile health application for ... “We the BE” is the first MHA developed for a rare disease, BEEC. It has been published in a downloadable format for the general public at no cost.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9940805

Need for Public Health Messaging Related to Bladder Health ... The purpose of this analysis was to explore adolescent and adult women's interest in public health messaging around bladder health using focus group data from ...