Smart-phone Application Versus Conventional Paper for the Documentation of Voiding Dysfunction in Children

Not Applicable

Not yet recruiting

• Conditions: Voiding Dysfunction; Children
• Interventions: Device: Smart-phone Voiding Diary; Diagnostic Test: Paper voiding diary

• Registration Number: NCT06404996
• Lead Sponsor: King Abdullah International Medical Research Center

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.

Study Timeline

• Study First Submitted: 2024-04-22
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-05
• Study First Posted: 2024-05-08
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Study Start: 2024-08-01
• Primary Completion: 2025-08-01
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart-phone diary	Smart-phone Voiding Diary	smart-phone voiding diary application
Paper diary	Paper voiding diary	Conventional paper based voiding diary

Primary Outcome Measures

Name	Time	Method
The percentage of diary completion	1 year	The percentage/number of patients of each group who will complete the diary and send it on-time.

Secondary Outcome Measures

Name	Time	Method
Patient's satisfaction assessment by the Voiding diary Satisfaction Questionnaire	1 year	Patient satisfaction will be assessed using a Voiding diary Satisfaction Questionnaire that can assess the ease of use of the diary chosen, as well as the compliance of diary completion and submission. The questionnaire consists of 6 subjective questions. Each question has 2-5 different answers with no objective scale.