跳至主要内容
临床试验/NCT05509738
NCT05509738终止不适用

Feasibility of A Text Message-Based Healthcare Assistant in Pediatric Lower Urinary Tract Symptoms Care

Stanford University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2022年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Usefulness and Acceptability of the Text4US program

研究概览

简要总结

Pediatric Lower Urinary Tract Symptoms (pLUTS) is common in school-age children and can negatively impact the quality of their life. Although at least 50% of children with pLUTS can improve through behavioral changes, how to support parents in helping their children adopt healthy bladder behaviors remains unrevealed. To solve this problem, the investigators developed an early model of a text message-based healthcare assistant. The aim of this study is to examine the feasibility of the text message-based healthcare assistant in pLUTS care.

详细描述

In this study, an early model of a text message-based healthcare assistant will be configured. The service provided by the proposed healthcare assistant includes (1) daily message reminders, and (2) daily achievement reflection. By employing the text message-based healthcare assistant in pLUTS care, the investigators hope to learn:

  1. If the text message-based healthcare assistant could support parents of children with pLUTS in helping their children adopt healthy bladder behaviors?
  2. What is parents' experience with the text message-based healthcare assistant in pLUTS care?
  3. How to improve the text-message-based healthcare assistant in the future?

To date, these questions have not been answered in the existing literature on digital health. The study findings will deepen the understanding of treatment options for pLUTS and provide an opportunity to optimize pediatric urology practice by integrating digital technology.

The study aims to evaluate the feasibility of using a text message-based healthcare assistant to support parents of children with LUTS in helping their children adopt healthy bladder behaviors. Therefore, the involvement of human subjects is necessary.

Parents/guardians of children (5-18 years old) who present to the pediatric urology outpatient clinic for the first visit for pLUTS or attend a clinic program called Bladder Bootcamp (a one-hour Zoom urotherapy education session in a non-medical, group setting) will be identified. Clinic staff or Bladder Bootcamp instructors will introduce the research staff to potential participants during the waiting time. A research team member will neutrally invite potential participants to participate in the study by briefly describing it. For those who are not interested, the research team member will thank them for their time and not proceed forward. For those who are interested, the research team member will provide them with further study details, screen their eligibility, and review the consent form with those who are eligible. The consent form will emphasize that:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
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/guardians (above the age of 18) of children (5-18 years old) who have completed potty training with pLUTS.
  • Parents/patients that have never completed a bladder/food diary before
  • Fluent in English
  • Able to receive text messages on a mobile device
  • Referred with a diagnosis of LUTS in our outpatient clinic

排除标准

  • Parents/guardians of children with
  • neurogenic bladder
  • Genitourinary (GU) abnormalities
  • Detrusor sphincter dyssynergia (DSD)
  • renal transplant patients (pre and post)
  • abdominal or spinal surgeries within one year
  • other chronic illness that is known to affect LUTS
  • currently on immunosuppression of any kind
  • younger than 5 years old or older than 18 years old
  • Younger than 18 years old
  • Not fluent in English
  • Not able to receive text messages
  • filled out a bladder and/or food diary before

结局指标

主要结局

Usefulness and Acceptability of the Text4US program

时间窗: 3 years

The usefulness and acceptability of the Text4US program as assessed by post-surveys adapted from Agyapong et al. (2013) with questions focusing on participants' engagement, satisfaction, experience, and intention to use. The responses differences between post-surveys of bladder and food diaries (control condition) and the Text4US program (intervention condition) will be examined. Besides, open-ended questions in post-surveys asking for participants' suggestions about the Text4US program will also be qualitatively analyzed.

Effectiveness of the Text4US program

时间窗: 3 years

The effectiveness of the Text4US program as assessed by: 1. participants' self-efficacy: one 5-point Likert Scale question focusing on participants' self-efficacy in healthy bladder behavior adoption, changes from baseline to the end of bladder \& food diaries phase (control condition), and the end of the Text4US phase (intervention condition) 2. participants' perceived effects: differences in participants' perceived effects of bladder and food diaries (control condition) and the Test4US program (intervention condition) on bladder health. Assessment questions are adapted from Agyapong et al. (2013) and presented in post-surveys. 3. children's healthy bladder behavior: differences in participant's self-reported healthy bladder behavior between bladder and food diaries (control condition) and reflection surveys (intervention condition).

Feasibility of Text-Messaging System

时间窗: 3 years

The feasibility of the Text4US program as assessed by: 1. study recruitment and retention rates 2. time required to recruit target participants 3. cost associated with developing the Text4US program and maintaining the program until the completion of data collection 4. participants' mobile/cell phone usage and preferred healthcare tools (assessed in pre-survey) 5. differences in completion rates between bladder and food diaries (control condition) and reflection surveys (intervention condition).

次要结局

未报告次要终点

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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