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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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06404996
Enrollment
100
Registered
2024-05-08
Start date
2024-08-01
Completion date
2026-02-28
Last updated
2024-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children, Voiding Dysfunction

Keywords

voiding dysfunction, bladder, children, voiding diary, smart-phone

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.

Interventions

DEVICESmart-phone Voiding Diary

Smart-phone Voiding Diary

DIAGNOSTIC_TESTPaper voiding diary

Conventional Paper voiding diary

Sponsors

King Abdullah International Medical Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The percentage of diary completion1 yearThe percentage/number of patients of each group who will complete the diary and send it on-time.

Secondary

MeasureTime frameDescription
Patient's satisfaction assessment by the Voiding diary Satisfaction Questionnaire1 yearPatient 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.

Contacts

Primary ContactAmr Hodhod, MD, PhD, Msc
hodhodam@mngha.med.sa+966118011111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026