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

Smart-phone Application Versus Conventional Paper for the Documentation of Voiding Dysfunction in Children: Which Diary is Most Advantageous

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Children; Voiding Dysfunction
• Intervention / Treatment: Device: Smart-phone Voiding Diary; Diagnostic test: Paper voiding diary

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amr Hodhod, MD, PhD, Msc; Phone Number: 53316 +966118011111; Email: hodhodam@mngha.med.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Paper diary; Conventional paper based voiding diary	Diagnostic test: Paper voiding diary; Conventional Paper voiding diary
Experimental: Smart-phone diary; smart-phone voiding diary application	Device: Smart-phone Voiding Diary; Smart-phone Voiding Diary; Other Names: DryDawn

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's satisfaction assessment by the Voiding diary Satisfaction Questionnaire	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.	1 year

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Investigators: Principal Investigator: Amr Hodhod, MD, PhD, Msc, King Abdullah International Medical Research Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: children; bladder; voiding dysfunction; smart-phone; voiding diary
• Other Study ID Numbers: IRB/0550/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because of data ownership policy of our institution, I may not able to share full data unless approved by the ethical committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No