Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404996
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-22
Brief Title:
Smart-phone Application Versus Conventional Paper for the Documentation of Voiding Dysfunction in Children
Sponsor:
King Abdullah International Medical Research Center
Organization:
King Abdullah International Medical Research Center
Study Overview
Official Title:
Smart-phone Application Versus Conventional Paper for the Documentation of Voiding Dysfunction in Children Which Diary is Most Advantageous
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Patient satisfaction will be assessed using a questionnaire that was designed for use in this study
Detailed Description:
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 patients satisfaction Consenting individuals will be informed of the study details and their safety will be assured Patientsparents 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 wwwrandomizerorg will be used to generate a randomized numbered lists that determine participant allocation to one of two study groups
Data collection will include patient demographics the type of diary used as well as the information that participants provide in either of the voiding the diaries and the satisfaction questionnaire The investigators will analyze the data and report on the percentage of participants who complied with their diary completion information provided by patients and caregivers in the diary and the number of participants in the study Moreover a questionnaire Voiding diary Satisfaction Questionnaire will be given to each family evaluating the patientcaregiver satisfaction
If the diary has to be repeated automatically will switch to the other type of diary A re-evaluation of the diary satisfaction
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 patients satisfaction Consenting individuals will be informed of the study details and their safety will be assured Patientsparents 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 wwwrandomizerorg will be used to generate a randomized numbered lists that determine participant allocation to one of two study groups
Data collection will include patient demographics the type of diary used as well as the information that participants provide in either of the voiding the diaries and the satisfaction questionnaire The investigators will analyze the data and report on the percentage of participants who complied with their diary completion information provided by patients and caregivers in the diary and the number of participants in the study Moreover a questionnaire Voiding diary Satisfaction Questionnaire will be given to each family evaluating the patientcaregiver satisfaction
If the diary has to be repeated automatically will switch to the other type of diary A re-evaluation of the diary satisfaction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None