Smart-phone Application Versus Conventional Paper for the Documentation of Voiding Dysfunction in Children: Which Diary is Most Advantageous
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- The percentage of diary completion
研究概览
简要总结
The objective of the research is to compare the written voiding diary method to the smart-phone diary, DryDawn®, which the investigators selected among several applications using specific criteria appropriate to our population. The investigators aim is to describe the method that proves to be most efficient by assessing which diary provides the best quality and amount of information, and draws the highest level of satisfaction from participants.
Patient satisfaction will be assessed using a questionnaire that was designed for use in this study.
详细描述
The idea of using smart-phone applications for the purpose of medical management is not new, however, results from studies have been variable and few have characterized their use in the management of disease in children. The propose of study is to conduct a a research that involves the use of a smart-phone voiding diary application in children.
The intention of this research is to identify which method of documentation, either a smart-phone voiding diary application or the conventional written diary, is most effective in gathering information from urology patients in the pediatric population.
The investigators will conduct a prospective randomized study to investigate which type of diary is better regarding data collection and patient's satisfaction. Consenting individuals will be informed of the study details and their safety will be assured. Patients/parents will be informed of their right to withdraw from the study at any moment.
The two groups refer to the two methods of documentation (diaries) to which will be randomly assigned .The diaries are the smart-phone diary application, DryDawn ® (The Arabic version), or the conventional pen-and-paper method.
A website (www.randomizer.org) will be used to generate a randomized numbered lists that determine participant allocation to one of two study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New patients who have a voiding dysfunction that necessitates the use of a voiding diary
- •Children ages six (6) to eighteen (18) years
- •Participants must own a smart-phone
排除标准
- •Children less than six (6) years of age
- •Participants who do not own a smart-phone
结局指标
主要结局
The percentage of diary completion
时间窗: 1 year
The percentage/number of patients of each group who will complete the diary and send it on-time.
次要结局
- Patient's satisfaction assessment by the Voiding diary Satisfaction Questionnaire(1 year)