Comparing the Usability of an Electronic Bladder Diary and a Paper Bladder Diary

NCT03249987 | Completed

• 1 other identifier: STH19309
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• The comparability between diary types

  Number of days with more than one entry

  3 days

Secondary Outcomes (2)

• The comparability of the data values obtained from the electronic bladder diary and the paper bladder diary for Mean daytime frequency of urination

  6 days

• Patient satisfaction and preference of the electronic bladder diary against the paper diary.

  6 days

Study Arms (2)

Electronic bladder diary

OTHER

Participants will be asked to complete the electronic diary for three days before crossing over to the paper diary. Patients will be asked to record the time and volume of voids, any incontinence or urgency episodes and sleep-wake times. Patients will be asked to complete a short questionnaire regarding their opinions

Other: bladder diary

Paper bladder diary

OTHER

Participants will be asked to complete the paper diary for three days before crossing over to the electronic diary. Patients will be asked to record the time and volume of voids, any incontinence or urgency episodes and sleep-wake times. Patients will be asked to complete a short questionnaire regarding their opinions

Other: bladder diary

Interventions

bladder diary OTHER

electronic diary to be completed for 3 days before crossover onto paper diary for 3 days

Electronic bladder diary; Paper bladder diary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with limited verbal and/or written communication problems

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Inman

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 15, 2017
• Study Start: August 30, 2016
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: September 10, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)