Clinical trial NCT06404996: Smart-phone Application Versus Conventional Paper for the Documentation of Voiding Dysfunction in Children
Official title: Smart-phone Application Versus Conventional Paper for the Documentation of Voiding Dysfunction in Children: Which Diary is Most Advantageous
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Voiding Dysfunction
Children
Keywords: voiding dysfunction
bladder
children
voiding diary
smart-phone
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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.

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 patient/caregiver satisfaction.

If the diary has to be repeated, automatically will switch to the other type of diary. A re-evaluation of the diary satisfaction.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Children less than six (6) years of age
* Participants who do not own a smart-phone

Primary outcomes:
measure: The percentage of diary completion
timeFrame: 1 year
Secondary outcomes:
measure: Patient's satisfaction assessment by the Voiding diary Satisfaction Questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: King Abdullah International Medical Research Center
name: Amr Hodhod, MD, PhD, Msc
role: PRINCIPAL_INVESTIGATOR
References: