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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249987
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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


Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Other: bladder diary Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparing the Usability of an Electronic Bladder Diary and a Paper Bladder Diary: a Two-way Crossover Study
Actual Study Start Date : August 30, 2016
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Electronic bladder diary
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
electronic diary to be completed for 3 days before crossover onto paper diary for 3 days

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




Primary Outcome Measures :
  1. The comparability between diary types [ Time Frame: 3 days ]
    Number of days with more than one entry


Secondary Outcome Measures :
  1. The comparability of the data values obtained from the electronic bladder diary and the paper bladder diary for Mean daytime frequency of urination [ Time Frame: 6 days ]
    average daytime frequency

  2. Patient satisfaction and preference of the electronic bladder diary against the paper diary. [ Time Frame: 6 days ]
    Whether a patient prefers using the electronic diary over the paper diary as measure by the patient preference questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249987


Locations
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United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2JF
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Richard Inman Sheffield Teaching Hospitals NHS Foundation Trust
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03249987    
Other Study ID Numbers: STH19309
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms