Comparison of a Paper and Automated Bladder Diary in Pediatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Universiteit Antwerpen
- Enrollment
- 60
- Locations
- 5
- Primary Endpoint
- Level of agreement average daytime volume (ml)
Study Overview
Brief Summary
The purpose of this study is to compare an automated bladder diary (autoBD) to a paper bladder diary (pBD) on their level of agreement, patient compliance and satisfaction. It is a mixed methods, randomized 2x2 crossover trial. Pediatric patients (6 to 12 years) presenting to the clinic and identified as requiring a bladder diary will be recruited. Participants will be randomized either to group 1, where they complete the paper bladder diary (pBD) and then the automated bladder diary (autoBD), or to group 2, where they complete the autoBD and then the pBD. Both diaries are kept for at least 2 consecutive days with a wash-out period of 2 to 6 days between the two diaries. Mean differences and the level of agreement between the pBD and autoBD will be analysed using Bland Altman plots for key diary parameters.
After completion of each diary format, participants will complete a short online survey regarding compliance, satisfaction and their preference, if any. Finally, a selection of participants and their parents will be invited for an open-ended interview.
The participating healthcare professionals will be asked to score each pBD and autoBD on patient compliance when processing the diary. Furthermore, surveys and open-ended interviews will be conducted to assess their overall satisfaction of each diary type and their preference, if any.
Detailed Description
For some time now, patient compliance with paper bladder diaries is being questioned. Paper bladder diaries are often incomplete, unreliable and/or of low quality. Multiple electronic bladder diaries have been developed to overcome some of the limitations associated with paper bladder diaries. However, based on several comparison studies between paper and electronic bladder diaries, it is not clear whether an electronic format alone is truly superior to the paper format. The investigators want to introduce and evaluate the feasibility of a new type of bladder diary: an automated bladder diary. In contrast to an electronic diary, an automated diary automatically registers voiding data using a connected measuring device. An electronic diary simply eliminates the use of paper, but the patient still needs to measure the voided volumes with a urinary container and manually enter them in the electronic diary. The investigators believe an automated diary may lead to improved patient compliance by reducing the required efforts from the patient and instead provide guidance and prompts.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Pediatric patients presenting to the clinic and identified as requiring a bladder diary
- •Age: 6 to 12 years
- •Sex: male or female
- •Child and/or parent own and are able to operate a smartphone and/or tablet
Exclusion Criteria
- •Change in urologic treatment during the data collection period
- •Inability to hold the Diary Pod while urinating
- •Inability to speak, read and write Dutch
Arms & Interventions
Paper bladder diary (pBD)
Patients will complete the paper bladder diary at home for at least 2 consecutive days.
Intervention: Paper bladder diary (Other)
Automated bladder diary (autoBD)
Patients will complete the automated bladder diary (Minze Diary Pod) at home for at least 2 consecutive days.
Intervention: Minze Diary Pod (Device)
Outcomes
Primary Outcomes
Level of agreement average daytime volume (ml)
Time Frame: Through study completion, an average of 1.5 year
What are the mean differences and the limits of agreement between the pBD and autoBD for average daytime volume (ml).
Secondary Outcomes
- Level of agreement nighttime voided volume versus 24h voided volume (%)(Through study completion, an average of 1.5 year)
- Level of agreement nighttime voided volume versus daytime voiding frequency(Through study completion, an average of 1.5 year)
- Patient compliance reported by patient(Through study completion, an average of 1.5 year)
- Patient compliance reported by healthcare provided(Through study completion, an average of 1.5 year)
- Level of agreement nighttime voided volume (ml)(Through study completion, an average of 1.5 year)
- Level of agreement maximum voided volume versus age expected bladder capacity (%)(Through study completion, an average of 1.5 year)
- Level of agreement nighttime voided volume versus age expected bladder capacity (%)(Through study completion, an average of 1.5 year)
- Level of agreement nighttime voided volume versus nighttime voiding frequency(Through study completion, an average of 1.5 year)
- Level of agreement average daytime volume versus age expected bladder capacity (%)(Through study completion, an average of 1.5 year)
- Level of agreement maximum voided volume (ml)(Through study completion, an average of 1.5 year)
- Level of agreement 24h voided volume (ml)(Through study completion, an average of 1.5 year)
- Patient satisfaction(Through study completion, an average of 1.5 year)
- Healthcare professional satisfaction(Through study completion, an average of 1.5 year)
Investigators
Lola Bladt
Sub-Investigator
Universiteit Antwerpen