Voiding DysfunctionNCT06404996
Smart-phone Application Versus Conventional Paper for the Documentation of Voiding Dysfunction in Children
A study testing Smart-phone Voiding Diary and Paper voiding diary in people with Voiding Dysfunction and Children, run by King Abdullah International Medical Research Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Voiding Dysfunction, Children
- What is being tested?
- Smart-phone Voiding Diary and Paper voiding diary
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Children less than six (6) years of age
- Participants who do not own a smart-phone
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- Smart-phone Voiding Diary, Paper voiding diary
- Keywords
- voiding dysfunction, bladder, children, voiding diary, smart-phone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart-phone Voiding DiaryDevice
Also called DryDawn
Smart-phone Voiding Diary
Paper voiding diaryDiagnostic test
Conventional Paper voiding diary
| Study group | Role | What they receive |
|---|---|---|
| Smart-phone diary | Experimental | smart-phone voiding diary application Receives: Device: Smart-phone Voiding Diary |
| Paper diary | Active comparator | Conventional paper based voiding diary Receives: Diagnostic Test: Paper voiding diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of diary completion
The percentage/number of patients of each group who will complete the diary and send it on-time.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Aug 2024 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Voiding DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr Hodhod, MD, PhD, Msc, Principal investigator, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404996
- Sponsor's protocol ID
- IRB/0550/24
- Status last verified
- May 2024
- First submitted
- 22 Apr 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because of data ownership policy of our institution, I may not able to share full data unless approved by the ethical committee
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart-phone Application Versus Conventional Paper for the Documentation of Voiding Dysfunction in Children: Which Diary is Most Advantageous
- ClinicalTrials.gov ID
- NCT06404996
- Acronym / sponsor ID
- IRB/0550/24
- Conditions
- Voiding Dysfunction, Children
- Keywords
- voiding dysfunction, bladder, children, voiding diary, smart-phone
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart-phone diary | Experimental | Device: Smart-phone Voiding Diarysmart-phone voiding diary application |
| Paper diary | Active comparator | Diagnostic Test: Paper voiding diaryConventional paper based voiding diary |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Children less than six (6) years of age
- Participants who do not own a smart-phone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart-phone Voiding DiaryAlso: DryDawnSmart-phone Voiding Diary | Device | Smart-phone diary |
| Paper voiding diaryConventional Paper voiding diary | Diagnostic test | Paper diary |
Primary outcome
The percentage of diary completion
Time frame: 1 year
The percentage/number of patients of each group who will complete the diary and send it on-time.
1 secondary outcome
Patient's satisfaction assessment by the Voiding diary Satisfaction Questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No. Because of data ownership policy of our institution, I may not able to share full data unless approved by the ethical committee
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amr Hodhod, MD, PhD, Msc principal investigator
King Abdullah International Medical Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Smart-phone Voiding Diary and Paper voiding diary in people with Voiding Dysfunction and Children, run by King Abdullah International Medical Research Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Hodhod, MD, PhD, Msc (+966118011111 ext. 53316, hodhodam@mngha.med.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of diary completion (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.