Health Knowledge, Attitudes, Practice
Conditions
Brief 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. 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
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.
Interventions
OTHERDigital Pediatric Bladder Health Patient Education Curriculum
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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single Group Longitudinal Study looking at pre- and post- results of the same group of patients.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Participants Recruited | 3 months | Recruitment was measured as the number and percentage of individuals who expressed interest, were screened, and provided consent. |
| Engagement: Video Completion Rate | 3 months | Engagement was measured by assessing the video completion rate (videos watched/total videos) as calculated by the video platform. |
| Post-assessment Completion Rates | 4-weeks and 12-weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Validated Acceptability Survey | Immediately after completing the videos (up to 4 weeks following baseline) | 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). |
| Validated Education Design Survey -- Parents | Immediately after completing the videos (up to 4 weeks following baseline) | 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. |
| Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | baseline, 4-weeks; 12-weeks | 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 |
| Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Immediately after completing the videos (up to 4 weeks following baseline) | 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. |
| Validated Education Design Survey - Children | Immediately after completing the videos (up to 4 weeks following baseline) | 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). |
| Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam | Baseline, Post-lesson (approximately 4 weeks) and 12 weeks post-intervention | 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. |
| Validated Self-efficacy Survey | Baseline and 4 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Parents of children aged 5-10 years with presence of lower urinary tract symptoms (LUTS), defined as dysfunctional voiding scoring system (DVSS) score \> 6 for girls, \>9 for boys, were recruited from our pediatric urology clinic, local pediatric practices and the community. Community recruitment involved flyers posted in public libraries, community and childcare centers and community-based organizations.
Pre-assignment details
268 families met eligibility criteria. 15 families submitted surveys the were found to be fraudulent. 102 families signed informed consent and were assigned to the study arm.
Participants by arm
| Arm | Count |
|---|---|
| Parent-Child Dyad - Parent Participants Each parent-child dyad receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks. | 70 |
| Parent-Child Dyad - Child Participants Each parent-child dyad receives the intervention (digital pediatric bladder health patient education curriculum). The intervention consists of 7 videos that can be viewed over a time period of up to 4 weeks. | 70 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Family (dyad did not have LUTS) who consented but withdrew | 1 |
| Overall Study | Family (dyad) who completed intervention but was lost to follow-up | 7 |
| Overall Study | Family (dyad) who consented but did not complete intervention | 24 |
| Overall Study | Family (dyad with LUTS) who consented but withdrew | 2 |
Baseline characteristics
| Characteristic | Parent-Child Dyad - Parent Participants | Parent-Child Dyad - Child Participants | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 70 Participants | 70 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 0 Participants | 70 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian or Asian American, not Hispanic or Latino | 27 Participants | 21 Participants | 48 Participants |
| Race/Ethnicity, Customized Black or African American, not Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic or Latino/a | 8 Participants | 7 Participants | 15 Participants |
| Race/Ethnicity, Customized Middle Eastern or North African | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White or European, not Hispanic or Latino | 33 Participants | 37 Participants | 70 Participants |
| Region of Enrollment United States | 70 Participants | 70 Participants | 140 Participants |
| Sex: Female, Male Female | 64 Participants | 47 Participants | 111 Participants |
| Sex: Female, Male Male | 6 Participants | 23 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 102 |
| other Total, other adverse events | 0 / 102 | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 | 0 / 102 |
Outcome results
Primary
Engagement: Video Completion Rate
Engagement was measured by assessing the video completion rate (videos watched/total videos) as calculated by the video platform.
Time frame: 3 months
Population: Parent-child dyads who signed informed consent, did not withdraw, and in which the child in the dyad had presence of lower urinary tract symptoms at baseline (DVSS score \> 6 in girls, \> 9 in boys)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parent-Child Dyad | Engagement: Video Completion Rate | Completed 80% - 100% of the curriculum | 50 Participants |
| Parent-Child Dyad | Engagement: Video Completion Rate | Completed 20% - 80% of the curriculum | 2 Participants |
| Parent-Child Dyad | Engagement: Video Completion Rate | Completed 0% - 20% of the curriculum | 18 Participants |
Primary
Number and Percentage of Participants Recruited
Recruitment was measured as the number and percentage of individuals who expressed interest, were screened, and provided consent.
Time frame: 3 months
Population: Parent-child dyads who completed the screening survey.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parent-Child Dyad | Number and Percentage of Participants Recruited | Expressed Interest (submitted survey) - all dyads | 429 Participants |
| Parent-Child Dyad | Number and Percentage of Participants Recruited | Eligible for Participation - dyads with LUTS at baseline | 183 Participants |
| Parent-Child Dyad | Number and Percentage of Participants Recruited | Consented - dyads with LUTS at baseline, excludes withdrawn dyads | 70 Participants |
Primary
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.
Time frame: 4-weeks and 12-weeks
Population: Parent-child dyads who completed the Bladder Basics video (based on parent's self-report) and completed initial post-lesson survey, and in which the child in the dyad had presence of lower urinary tract symptoms at baseline (DVSS score \> 6 in girls, \> 9 in boys)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parent-Child Dyad | Post-assessment Completion Rates | Completed 4-week survey | 51 Participants |
| Parent-Child Dyad | Post-assessment Completion Rates | Completed 12-week survey | 47 Participants |
Secondary
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
Time frame: baseline, 4-weeks; 12-weeks
Population: Children with LUTS at baseline and who completed the 4-week and 12-week surveys, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | baseline score - 4-week survey completers (both genders) | 11.51 score on a scale | Standard Deviation 3.12 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | 4-weeks score - 4-week survey completers (both genders) | 8.47 score on a scale | Standard Deviation 4.61 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | baseline score - 4-week survey completers (girls) | 11.38 score on a scale | Standard Deviation 3.41 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | 4-weeks score - 4-week survey completers (girls) | 8.30 score on a scale | Standard Deviation 4.37 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | baseline score - 4-week survey completers (boys) | 11.86 score on a scale | Standard Deviation 2.25 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | 4-weeks score - 4-week survey completers (boys) | 8.93 score on a scale | Standard Deviation 5.34 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | baseline score - 12-week survey completers (both genders) | 11.53 score on a scale | Standard Deviation 3.17 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | 12-weeks score - 12-week survey completers (both genders) | 6.62 score on a scale | Standard Deviation 3.87 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | baseline score - 12-week survey completers (girls) | 11.40 score on a scale | Standard Deviation 3.43 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | 12-weeks score - 12-week survey completers (girls) | 6.80 score on a scale | Standard Deviation 3.95 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | baseline score - 12-week survey completers (boys) | 11.92 score on a scale | Standard Deviation 2.35 |
| Parent-Child Dyad | Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes | 12-weeks score - 12-week survey completers (boys) | 6.08 score on a scale | Standard Deviation 3.73 |
Secondary
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.
Time frame: Immediately after completing the videos (up to 4 weeks following baseline)
Population: The Overall Number of Participants Analyzed represents the number of parent-child dyads who completed the Bladder Basics video (based on parent's self-report) and who completed initial post-intervention survey, and in which the child in the dyad had presence of lower urinary tract symptoms at baseline (DVSS score \> 6 in girls, \> 9 in boys).
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Affective attitude | 48 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Age appropriateness | 10 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Burden | 90 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Course content: Educational topics | 15 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Course content: Presentation format | 43 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Future content: Epidemiology of pediatric bladder health | 3 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Future content: Bathroom use best practices | 8 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Future content: Bathroom pathology content | 28 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Future content: Dietary Information and Bowel habits | 9 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Future content: Format suggestions | 10 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Future content: No changes needed | 24 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | General acceptability | 6 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Intervention coherence | 6 Excerpts |
| Parent-Child Dyad | Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program | Perceived effectiveness | 12 Excerpts |
Secondary
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.
Time frame: Baseline, Post-lesson (approximately 4 weeks) and 12 weeks post-intervention
Population: Parents of children with LUTS at baseline and who completed immediate post-video survey and 12-week survey, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Parent-Child Dyad | Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam | Baseline - post-lesson survey completers | 10 score on a scale |
| Parent-Child Dyad | Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam | Post-lesson score - post-lesson survey completers | 11 score on a scale |
| Parent-Child Dyad | Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam | Baseline - 12-week survey completers | 10 score on a scale |
| Parent-Child Dyad | Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam | 12-week score - 12-week survey completers | 11 score on a scale |
Secondary
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).
Time frame: Immediately after completing the videos (up to 4 weeks following baseline)
Population: Parents of children with LUTS at baseline who completed the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent-Child Dyad | Validated Acceptability Survey | 4.306 score on a scale | Standard Deviation 0.49 |
Secondary
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).
Time frame: Immediately after completing the videos (up to 4 weeks following baseline)
Population: Children with LUTS at baseline who completed the intervention.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Parent-Child Dyad | Validated Education Design Survey - Children | Fun | Strongly disagree | 1 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Fun | Disagree | 1 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Fun | Neither agree or disagree | 4 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Fun | Agree | 15 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Fun | Strongly agree | 31 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Important | Strongly disagree | 1 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Important | Disagree | 1 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Important | Neither agree or disagree | 2 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Important | Agree | 12 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Important | Strongly agree | 36 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Easy | Strongly disagree | 0 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Easy | Disagree | 1 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Easy | Neither agree or disagree | 7 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Easy | Agree | 20 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Easy | Strongly agree | 24 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Enjoyable | Strongly disagree | 3 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Enjoyable | Disagree | 1 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Enjoyable | Neither agree or disagree | 2 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Enjoyable | Agree | 16 Participants |
| Parent-Child Dyad | Validated Education Design Survey - Children | Enjoyable | Strongly agree | 30 Participants |
Secondary
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.
Time frame: Immediately after completing the videos (up to 4 weeks following baseline)
Population: Parents of children with LUTS at baseline who completed the intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parent-Child Dyad | Validated Education Design Survey -- Parents | 4.31 score on a scale | Standard Deviation 0.49 |
Secondary
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.
Time frame: Baseline and 4 weeks
Population: Parents of children with LUTS at baseline and who completed the baseline and 4-week surveys.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parent-Child Dyad | Validated Self-efficacy Survey | Baseline | 63.12 score on a scale | Standard Deviation 16.82 |
| Parent-Child Dyad | Validated Self-efficacy Survey | 4-weeks | 70.84 score on a scale | Standard Deviation 17.16 |