<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03249987</url>
  </required_header>
  <id_info>
    <org_study_id>STH19309</org_study_id>
    <nct_id>NCT03249987</nct_id>
  </id_info>
  <brief_title>Comparing the Usability of an Electronic Bladder Diary and a Paper Bladder Diary</brief_title>
  <official_title>Comparing the Usability of an Electronic Bladder Diary and a Paper Bladder Diary: a Two-way Crossover Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This piece of research is a single centre, two-way cross over, prospective study to compare&#xD;
      the outcomes and experience of patients completing a paper bladder diary and an electronic&#xD;
      version. This project aims to examine whether an electronic bladder diary can improve data&#xD;
      quality compared to a paper bladder diary. Participants will attend an introduction&#xD;
      appointment within the Urology Department at Royal Hallamshire Hospital. The participant will&#xD;
      complete the bladder diaries at home and will then complete a questionnaire at the Royal&#xD;
      Hallamshire Hospital.&#xD;
&#xD;
      Patients who are being sent an appointment for urodynamics (standard or video) will be also&#xD;
      sent a recruitment letter and participant information sheet (PIS), to inform them of the&#xD;
      study. One week later a member of the study team will phone the patient, to see if they are&#xD;
      interested in participating in the study and assess the eligibility criteria. If that patient&#xD;
      is interested and they fulfil the inclusion/exclusion criteria they will be invited to attend&#xD;
      an introduction appointment. This will be conducted 1-2 weeks prior to the urodynamic test,&#xD;
      at which point study details will be discussed and written informed consent will be taken.&#xD;
      The participant will be taught how to use the digital and paper versions of the bladder&#xD;
      diaries&#xD;
&#xD;
      Participants will be asked to complete the electronic diary for three days and the paper&#xD;
      diary for three days. Half of the participants will complete the digital diary first, the&#xD;
      other half will complete the paper diary first, and this will be done by alternating&#xD;
      consecutively. Patients will be asked to record the time and volume of voids, any&#xD;
      incontinence or urgency episodes and sleep-wake times. On the day of their urodynamics&#xD;
      appointment, patients should return with their electronic and paper diaries&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Micturition time-charts, frequency-volume charts and bladder diaries are inexpensive,&#xD;
      non-invasive tools that allow the assessment of lower urinary tract symptoms (Konstantinidis&#xD;
      et al. 2011); with a large proportion of women giving them low burden scores (Vella et al.&#xD;
      2012).&#xD;
&#xD;
      A micturition time chart records 'the times of micturitions, day and night, for at least 24&#xD;
      hours' (Abrams et al. 2002), whereas frequency-volume charts record 'the volumes voided as&#xD;
      well as the time of each micturition, day and night, for at least 24 hours' (Abrams et al.&#xD;
      2002) and a bladder diary 'records the times of micturitions and voided volumes, incontinence&#xD;
      episodes, pad usage and other information such as fluid intake, the degree of urgency and the&#xD;
      degree of incontinence' (Abrams et al. 2002). However, the three terms are often used&#xD;
      interchangeably in the literature, purely meaning documentation of void time, volume and +/-&#xD;
      urgency.&#xD;
&#xD;
      Frequency-volume charts are used to record patients' symptoms before and after therapeutic&#xD;
      interventions and in bladder training, to assess the success of the treatment (Abrams and&#xD;
      Klevmark, 1996).&#xD;
&#xD;
      NICE (2013) states that men with bothersome lower urinary tract symptoms should complete a&#xD;
      urinary frequency-volume chart as part of their initial assessment. They provide information&#xD;
      on: daytime frequency, nocturia, 24-hour frequency, 24-hour production, polyuria, nocturnal&#xD;
      urine volume, nocturnal polyuria and maximum voided volume (Abrams et al. 2002).&#xD;
      Frequency-volume charts can help to distinguish between nocturnal polyuria and detrusor&#xD;
      overactivity by assessing the volume of urine voided (NICE, 2013).&#xD;
&#xD;
      Frequency-volume charts provide an insight in a patient's voiding patterns in their own&#xD;
      environment and during their usual daily activities (Konstantinidis et al. 2011). A high&#xD;
      test-retest reliability been shown for frequency-volume charts (Jimenez-Cidre et al. 2015;&#xD;
      Yap et al. 2007), demonstrating their dependability.&#xD;
&#xD;
      The use of a frequency-volume chart can reduce recall error (Locker et al. 2001), as when&#xD;
      retrospectively assessed &gt;50% of patients overestimated daytime frequency in comparison to&#xD;
      their frequency-volume chart (Stav et al. 2009).&#xD;
&#xD;
      Electronic diaries have been trailed in other areas of healthcare, most with success.&#xD;
      Electronic diaries used to monitor asthma symptoms (Jiang et al. 2009), pain (Stone et al.&#xD;
      2003), headaches (Allena et al. 2012), amongst others showed to have a higher compliance&#xD;
      compared to paper diaries.&#xD;
&#xD;
      Stone et al. (2003) compared the completion of a paper and electronic pain diary. The paper&#xD;
      diary was fitted with a hidden device to track the opening and closing of the binder, to help&#xD;
      monitor completion. It was found that on 32% of study days the paper diary was not opened,&#xD;
      yet the compliance for these days was &gt;90%. This suggests there has been backfilling of data,&#xD;
      questioning the reliability of the data. This is further confirmed by Gaertner et al. (2004)&#xD;
      who demonstrated more retrospective fabrication of data in the paper diary.&#xD;
&#xD;
      Broderick (2008) suggested that the time taken for data analysis is significantly reduced&#xD;
      when using an electronic diary compared to a paper diary. However, the time for software&#xD;
      installation and training should be taken into consideration.&#xD;
&#xD;
      A pain monitoring study showed that electronic diaries had a higher rate of compliance and&#xD;
      less back dating of information (Stone et al. 2003).&#xD;
&#xD;
      Despite a number of patients lacking experience in the use of computers, patient satisfaction&#xD;
      was higher for the electronic diary in a number of studies (Gaertner et al. 2004; Broderick,&#xD;
      2008), with many saying it was easy to understand and to use (Allena et al. 2012)&#xD;
&#xD;
      This is a single centre, two-way cross over, prospective study to compare the outcomes and&#xD;
      experience of patients completing a paper bladder diary and an electronic&#xD;
      version.Participants will attend an introduction appointment within the Urology Department at&#xD;
      Royal Hallamshire Hospital. The room will ensure privacy for the patient. The participant&#xD;
      will complete the bladder diaries at home. The participant will complete the questionnaire at&#xD;
      the Royal Hallamshire hospital, in private.Participants will be asked to complete the&#xD;
      electronic diary for three days and the paper diary for three days. Half of the participants&#xD;
      will complete the digital diary first, the other half will complete the paper diary first,&#xD;
      and this will be done by alternating consecutively.&#xD;
&#xD;
      Patients will be asked to record the time and volume of voids, any incontinence or urgency&#xD;
      episodes and sleep-wake times. Patients return one week later with their electronic and paper&#xD;
      diaries. Patients will be asked to complete a short questionnaire regarding their opinions.&#xD;
      Clinicians should analyse the data as usual. Introduction and follow-up appointments will try&#xD;
      to be arranged around patients' hospital appointments to avoid additional visits. Patients&#xD;
      will be provided with an ELAROS electronic bladder diary as the electronic diary.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2016</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The comparability between diary types</measure>
    <time_frame>3 days</time_frame>
    <description>Number of days with more than one entry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The comparability of the data values obtained from the electronic bladder diary and the paper bladder diary for Mean daytime frequency of urination</measure>
    <time_frame>6 days</time_frame>
    <description>average daytime frequency</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction and preference of the electronic bladder diary against the paper diary.</measure>
    <time_frame>6 days</time_frame>
    <description>Whether a patient prefers using the electronic diary over the paper diary as measure by the patient preference questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>Electronic bladder diary</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paper bladder diary</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>bladder diary</intervention_name>
    <description>electronic diary to be completed for 3 days before crossover onto paper diary for 3 days</description>
    <arm_group_label>Electronic bladder diary</arm_group_label>
    <arm_group_label>Paper bladder diary</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be ≥18 years old&#xD;
&#xD;
          -  Patients must speak, read and write English&#xD;
&#xD;
          -  Willing to participate in the study and able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients with limited verbal and/or written communication problems&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Inman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>September 7, 2018</last_update_submitted>
  <last_update_submitted_qc>September 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan to share IPD</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03249987
org study id: STH19309
nct id: NCT03249987
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
Micturition time-charts, frequency-volume charts and bladder diaries are inexpensive,
      non-invasive tools that allow the assessment of lower urinary tract symptoms (Konstantinidis
      et al. 2011); with a large proportion of women giving them low burden scores (Vella et al.
      2012).

      A micturition time chart records 'the times of micturitions, day and night, for at least 24
      hours' (Abrams et al. 2002), whereas frequency-volume charts record 'the volumes voided as
      well as the time of each micturition, day and night, for at least 24 hours' (Abrams et al.
      2002) and a bladder diary 'records the times of micturitions and voided volumes, incontinence
      episodes, pad usage and other information such as fluid intake, the degree of urgency and the
      degree of incontinence' (Abrams et al. 2002). However, the three terms are often used
      interchangeably in the literature, purely meaning documentation of void time, volume and +/-
      urgency.

      Frequency-volume charts are used to record patients' symptoms before and after therapeutic
      interventions and in bladder training, to assess the success of the treatment (Abrams and
      Klevmark, 1996).

      NICE (2013) states that men with bothersome lower urinary tract symptoms should complete a
      urinary frequency-volume chart as part of their initial assessment. They provide information
      on: daytime frequency, nocturia, 24-hour frequency, 24-hour production, polyuria, nocturnal
      urine volume, nocturnal polyuria and maximum voided volume (Abrams et al. 2002).
      Frequency-volume charts can help to distinguish between nocturnal polyuria and detrusor
      overactivity by assessing the volume of urine voided (NICE, 2013).

      Frequency-volume charts provide an insight in a patient's voiding patterns in their own
      environment and during their usual daily activities (Konstantinidis et al. 2011). A high
      test-retest reliability been shown for frequency-volume charts (Jimenez-Cidre et al. 2015;
      Yap et al. 2007), demonstrating their dependability.

      The use of a frequency-volume chart can reduce recall error (Locker et al. 2001), as when
      retrospectively assessed >50% of patients overestimated daytime frequency in comparison to
      their frequency-volume chart (Stav et al. 2009).

      Electronic diaries have been trailed in other areas of healthcare, most with success.
      Electronic diaries used to monitor asthma symptoms (Jiang et al. 2009), pain (Stone et al.
      2003), headaches (Allena et al. 2012), amongst others showed to have a higher compliance
      compared to paper diaries.

      Stone et al. (2003) compared the completion of a paper and electronic pain diary. The paper
      diary was fitted with a hidden device to track the opening and closing of the binder, to help
      monitor completion. It was found that on 32% of study days the paper diary was not opened,
      yet the compliance for these days was >90%. This suggests there has been backfilling of data,
      questioning the reliability of the data. This is further confirmed by Gaertner et al. (2004)
      who demonstrated more retrospective fabrication of data in the paper diary.

      Broderick (2008) suggested that the time taken for data analysis is significantly reduced
      when using an electronic diary compared to a paper diary. However, the time for software
      installation and training should be taken into consideration.

      A pain monitoring study showed that electronic diaries had a higher rate of compliance and
      less back dating of information (Stone et al. 2003).

      Despite a number of patients lacking experience in the use of computers, patient satisfaction
      was higher for the electronic diary in a number of studies (Gaertner et al. 2004; Broderick,
      2008), with many saying it was easy to understand and to use (Allena et al. 2012)

      This 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.Participants will attend an introduction appointment within the Urology Department at
      Royal Hallamshire Hospital. The room will ensure privacy for the patient. The participant
      will complete the bladder diaries at home. The participant will complete the questionnaire at
      the Royal Hallamshire hospital, in private.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. Patients return one week later with their electronic and paper
      diaries. Patients will be asked to complete a short questionnaire regarding their opinions.
      Clinicians should analyse the data as usual. Introduction and follow-up appointments will try
      to be arranged around patients' hospital appointments to avoid additional visits. Patients
      will be provided with an ELAROS electronic bladder diary as the electronic diary.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The comparability between diary types
time frame: 3 days
description: Number of days with more than one entry
measure: 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
description: average daytime frequency
measure: Patient satisfaction and preference of the electronic bladder diary against the paper diary.
time frame: 6 days
description: Whether a patient prefers using the electronic diary over the paper diary as measure by the patient preference questionnaire
arm group label: Electronic bladder diary
arm group type: Other
description: 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
arm group label: Paper bladder diary
arm group type: Other
description: 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
intervention type: Other
intervention name: bladder diary
description: electronic diary to be completed for 3 days before crossover onto paper diary for 3 days
arm group label: Electronic bladder diary
arm group label: Paper bladder diary
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard Inman
role: Principal Investigator
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lower Urinary Tract Symptoms
sharing ipd: No
ipd description: no plan to share IPD