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

September 7, 2018 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

Comparing the Usability of an Electronic Bladder Diary and a Paper Bladder Diary: a Two-way Crossover Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The comparability between diary types
Time Frame: 3 days
Number of days with more than one entry
3 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 days
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
6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard Inman, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STH19309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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