205 Participants Needed

Digital Bladder Health Education for Improving Children's Health Literacy

(Bladder Basics Trial)

CL
Overseen ByChenxi Liu, MEd
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment Digital Pediatric Bladder Health Patient Education Curriculum?

Research shows that better health literacy, which can be improved through education, is linked to better compliance with treatment protocols in bladder cancer patients. This suggests that educational programs like the Digital Pediatric Bladder Health Patient Education Curriculum could help improve health outcomes by enhancing children's understanding of their condition.12345

Is the Digital Bladder Health Education program safe for children?

There is no specific safety data available for the Digital Bladder Health Education program, but general studies on pediatric patient safety highlight common issues like medication errors and electronic health record challenges, which are not directly related to this educational program.678910

How is the Digital Pediatric Bladder Health Patient Education Curriculum different from other treatments for children's bladder health?

This treatment is unique because it focuses on improving children's health literacy through digital education, empowering them to understand and manage their bladder health better. Unlike traditional treatments that may focus on medication or physical interventions, this approach uses digital tools to enhance knowledge and decision-making skills.1112131415

Research Team

KK

Kathleen Kan, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Exclusion Criteria

Does not meet inclusion criteria
I am under 18 years old.

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Single arm longitudinal assessmentExperimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Findings from Research

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.
Health literacy in pediatric otolaryngology: A scoping review.Aaronson, NL., Joshua, CL., Boss, EF.[2018]
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.
Adverse events and preventable adverse events in children.Woods, D., Thomas, E., Holl, J., et al.[2007]
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.
Safe Care for Pediatric Patients: A Scoping Review Across Multiple Health Care Settings.Stang, A., Thomson, D., Hartling, L., et al.[2017]

References

Websites on Bladder Cancer: an Appropriate Source of Patient Information? [2020]
An analysis of the readability of patient information materials for common urological conditions. [2020]
Evaluation of the relationship between compliance with the follow-up and treatment protocol and health literacy in bladder tumor patients. [2020]
Readability analysis of online health information about overactive bladder. [2021]
Health literacy in pediatric otolaryngology: A scoping review. [2018]
Adverse events and preventable adverse events in children. [2007]
Safe Care for Pediatric Patients: A Scoping Review Across Multiple Health Care Settings. [2017]
Identifying Electronic Health Record Usability And Safety Challenges In Pediatric Settings. [2019]
CareTrack Kids-part 3. Adverse events in children's healthcare in Australia: study protocol for a retrospective medical record review. [2019]
Adverse drug events and medication errors in Japanese paediatric inpatients: a retrospective cohort study. [2022]
[Digital health literacy-conceptual contextualization, measurement, and promotion]. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Health literacy in adolescents: an integrative review. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Evaluation of a web portal for improving public access to evidence-based health information and health literacy skills: a pragmatic trial. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Validation of the Rapid Estimate for Adolescent Literacy in Medicine Short Form (REALM-TeenS). [2023]
Generic health literacy measurement instruments for children and adolescents: a systematic review of the literature. [2023]
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