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

NCT06404996 | Not Yet Recruiting DMC

• 1 other identifier: IRB/0550/24
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Voiding Dysfunction; Children

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient's satisfaction assessment by the Voiding diary Satisfaction Questionnaire

  1 year

Study Arms (2)

Smart-phone diary

EXPERIMENTAL

smart-phone voiding diary application

Device: Smart-phone Voiding Diary

Paper diary

ACTIVE COMPARATOR

Conventional paper based voiding diary

Diagnostic Test: Paper voiding diary

Interventions

Smart-phone Voiding Diary DEVICE

Smart-phone Voiding Diary

Also known as: DryDawn

Smart-phone diary

Paper voiding diary DIAGNOSTIC_TEST

Conventional Paper voiding diary

Paper diary

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead

Study Officials

• Amr Hodhod, MD, PhD, Msc

  King Abdullah International Medical Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr Hodhod, MD, PhD, Msc

CONTACT

+966118011111; hodhodam@mngha.med.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 8, 2024
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: February 28, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share