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

NCT ID: NCT06404996

Last Updated: 2024-05-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2026-02-28

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.

Conditions

Voiding Dysfunction; Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Smart-phone diary

smart-phone voiding diary application

Group Type: EXPERIMENTAL

Smart-phone Voiding Diary

Intervention Type: DEVICE

Smart-phone Voiding Diary

Paper diary

Conventional paper based voiding diary

Group Type: ACTIVE_COMPARATOR

Paper voiding diary

Intervention Type: DIAGNOSTIC_TEST

Conventional Paper voiding diary

Interventions

Smart-phone Voiding Diary

Smart-phone Voiding Diary

Intervention Type: DEVICE

Paper voiding diary

Conventional Paper voiding diary

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

DryDawn

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Abdullah International Medical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amr Hodhod, MD, PhD, Msc

Role: PRINCIPAL_INVESTIGATOR

King Abdullah International Medical Research Center

Central Contacts

Amr Hodhod, MD, PhD, Msc

Role: CONTACT

hodhodam@mngha.med.sa

+966118011111 ext. 53316

Other Identifiers

IRB/0550/24

Identifier Type: -

Identifier Source: org_study_id