Impact, Feasibility, and Acceptability of Bladder Basics

Study Overview
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Brief Summary
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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

Detailed Description
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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 dependent variables measured are short- and long-term parental bladder health knowledge and child LUTS before and after exposure to the independent variable, Bladder Basics. The investigators will obtain information on a comprehensive range of secondary outcomes as potential covariates that inform feasibility and will be considered in future design. 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.

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

Conditions
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Health Knowledge, Attitudes, Practice

Intervention / Treatment
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* Other: Digital Pediatric Bladder Health Patient Education Curriculum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents or guardians >= 18 years of age involved in the care of a child 5-10 years old with bladder problems English speaking Exclusion Criteria: Individuals <18 years old. Does not meet inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Single Group Longitudinal Study looking at pre- and post- results of the same group of patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm longitudinal assessment<br>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. | Other: Digital Pediatric Bladder Health Patient Education Curriculum<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 scale is defined using the following five levels: Almost Never - Less Than Half the Time - About Half the Time - Almost Every Time - Not available. Children with a higher DVSS score have more frequent symptoms and/or behavioral problems | 3 months | 
| Pre-intervention to post-intervention knowledge survey created by research team | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. It's a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate better acceptability. | 1 month | 
| 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). This scale uses the following five levels: strongly disagree, disagree, agree, strongly agree, and NA. Higher scores indicate higher levels of self-efficacy. | 1 month | 
| Validated education design survey | 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. It's a 5-point Likert scale ranging from 1 (not true) to 5 (very true). Higher scores indicate better education design. | 1 month | 
| Learning progress and completion rate assessed by learning modules completion rate. | The data will help to measure the acceptability and feasibility of the Bladder Basics program. The data will be collected by the learning management system used to deliver Bladder Basics. The data will be reported in an aggregated format without any identifiable information. | 1 month | 
| Learning progress and completion rate assessed by time spend on each course | The data will help to measure the acceptability and feasibility of the Bladder Basics program. The data will be collected by the learning management system used to deliver Bladder Basics. The data will be reported in an aggregated format without any identifiable information. | 1 month | 
| Open-ended feedback questions to measure acceptability and feasibility of education program | To measure acceptability and feasibility of Bladder Basics with consideration of stakeholder, educational design, and behavioral change theory barriers. Open-ended feedback questions will be used to characterize the intervention's ability to be used as a population-level intervention. | 1 month |