Comparing the Usability of an Electronic Bladder Diary and a Paper Bladder Diary: a Two-way Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- The comparability between diary types
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with limited verbal and/or written communication problems
研究组 & 干预措施
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
干预措施: bladder diary (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
干预措施: bladder diary (Other)
结局指标
主要结局
The comparability between diary types
时间窗: 3 days
Number of days with more than one entry
次要结局
- 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)