Lower Urinary Tract Symptoms Clinical Trial
Official title:
Comparing the Usability of an Electronic Bladder Diary and a Paper Bladder Diary: a Two-way Crossover Study
NCT number | NCT03249987 |
Other study ID # | STH19309 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 30, 2016 |
Est. completion date | April 30, 2018 |
Verified date | August 2017 |
Source | Sheffield Teaching Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This piece of research is a single centre, two-way cross over, prospective study to compare
the outcomes and experience of patients completing a paper bladder diary and an electronic
version. This project aims to examine whether an electronic bladder diary can improve data
quality compared to a paper bladder diary. Participants will attend an introduction
appointment within the Urology Department at Royal Hallamshire Hospital. The participant will
complete the bladder diaries at home and will then complete a questionnaire at the Royal
Hallamshire Hospital.
Patients who are being sent an appointment for urodynamics (standard or video) will be also
sent a recruitment letter and participant information sheet (PIS), to inform them of the
study. One week later a member of the study team will phone the patient, to see if they are
interested in participating in the study and assess the eligibility criteria. If that patient
is interested and they fulfil the inclusion/exclusion criteria they will be invited to attend
an introduction appointment. This will be conducted 1-2 weeks prior to the urodynamic test,
at which point study details will be discussed and written informed consent will be taken.
The participant will be taught how to use the digital and paper versions of the bladder
diaries
Participants will be asked to complete the electronic diary for three days and the paper
diary for three days. Half of the participants will complete the digital diary first, the
other half will complete the paper diary first, and this will be done by alternating
consecutively. Patients will be asked to record the time and volume of voids, any
incontinence or urgency episodes and sleep-wake times. On the day of their urodynamics
appointment, patients should return with their electronic and paper diaries
Status | Completed |
Enrollment | 18 |
Est. completion date | April 30, 2018 |
Est. primary completion date | April 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must be =18 years old - Patients must speak, read and write English - Willing to participate in the study and able to provide written informed consent Exclusion Criteria: • Patients with limited verbal and/or written communication problems |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Hallamshire Hospital | Sheffield |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The comparability between diary types | Number of days with more than one entry | 3 days | |
Secondary | The comparability of the data values obtained from the electronic bladder diary and the paper bladder diary for Mean daytime frequency of urination | average daytime frequency | 6 days | |
Secondary | Patient satisfaction and preference of the electronic bladder diary against the paper diary. | Whether a patient prefers using the electronic diary over the paper diary as measure by the patient preference questionnaire | 6 days |
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