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临床试验/NCT05852353
NCT05852353已完成不适用

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

Stanford University2 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2023年8月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
204
试验地点
2
主要终点
Number and Percentage of Participants Recruited

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Number and Percentage of Participants Recruited

时间窗: 3 months

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

Engagement: Video Completion Rate

时间窗: 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

时间窗: 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.

次要结局

  • Change in Dysfunctional Voiding Symptom Score (DVSS) to Evaluate Bladder Health Clinical Outcomes(baseline, 4-weeks; 12-weeks)
  • Pre-intervention to Post-intervention Knowledge Survey Created by ResearchTeam(Baseline, Post-lesson (approximately 4 weeks) and 12 weeks post-intervention)
  • Validated Self-efficacy Survey(Baseline and 4 weeks)
  • Validated Acceptability Survey(Immediately after completing the videos (up to 4 weeks following baseline))
  • Validated Education Design Survey -- Parents(Immediately after completing the videos (up to 4 weeks following baseline))
  • Validated Education Design Survey - Children(Immediately after completing the videos (up to 4 weeks following baseline))
  • Open-ended Feedback Questions to Measure Acceptability and Feasibility of Education Program(Immediately after completing the videos (up to 4 weeks following baseline))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathleen Kan

CLINICAL ASSISTANT PROFESSOR, UROLOGY

Stanford University

研究点 (2)

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