Effect of Individualized Patient Education Including Drinking Advice Using an App
2019年12月4日 更新者：Maastricht University Medical Center
Study evaluating the effect of a personalized smart phone application in addition to standard care on bowel preparation scores, compared to standard care alone.
研究概览
详细说明
Picoprep is a low-volume bowel preparation used to optimize visualization of the colonic mucosa during colonoscopy.
Patients referred for a colonoscopy will be scheduled for an intake.
During this intake patients receive education about Picoprep and will be asked about their health condition (medical history, medication use).
Standard a face-to-face education is given by an intake nurse or doctor.
The producers of Picoprep, Ferring BV designed an app including a drinking schedule adapted to the timing of the coloscopy, aiming a lag time between intake of the last Picoprep dose and the scopy of 2-4 hours.
We hypothesize that the Boston Bowel Preparation Scale and patient satisfaction will be higher in patients receiving standard education plus using the bowel preparation app versus patients receiving single standard education.
研究类型
介入性
注册 (实际的)
180
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Limburg
-
Maastricht、Limburg、荷兰、6202AZ
- Maastricht University Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients refered to our clinic for colonoscopy by general practitioner, colorectal cancer screening programme or outpatient clinic
- Use of regular sodium picosulfate bowel preparation scheme
- Possession of an Android or iOS smart phone
Exclusion Criteria:
- Emergency colonoscopy
- Hospitalized patients
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：Control
patients receiving standard care (verbal and written instructions) before colonoscopy
|
|
|
实验性的：Intervention
Patients instructed to use a smart phone patient education app in addition standard care
|
Smart phone patient education application including a personalized colonoscopy preparation scheme and information about the procedure.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Boston Bowel Preparation Score
大体时间：During colonoscopy
|
Boston Bowel Preparation Score (BBPS) is a validated scale for scoring bowel preparation.
Each colonic segment (ascending, transverse, descending) is scored on a scale ranging from 0 to 3, in which a higher value means a cleaner bowel segment.
The total score is the sum of the three segment scores (total range 0-9).
|
During colonoscopy
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient satisfaction questionnaire
大体时间：end of preparation procedure
|
Patient satisfaction questionnaire.
Several questions in our PSQ (patient satisfaction questionnaire) are based on the PSQ-18.
We transformed items from the PSQ-18 to bowel preparation education purposes.
The PSQ-18 yields separate scores for each of seven different subscales: General Satisfaction; Technical Quality; Interpersonal Manner; Communication; Financial Aspects; Time Spent with Doctor and Accessibility and Convenience (8, 9).
Our PSQ contains items for General Satisfaction (items 3 and 6), Technical Quality (items 8 and 9), Communication (items 1 and 2), Time spent on education (item 7) and Convenience (items 4 and 5).
Second, general questions are asked to determine if this was the first time patient received bowel preparation education.
And last, for the app users we want to know how they rate the use of the app.
|
end of preparation procedure
|
|
Caecal intubation rate
大体时间：during colonoscopy
|
Total time from insertion of the endoscope to intubation of the caecum.
|
during colonoscopy
|
|
Adenoma detection rate
大体时间：during colonoscopy
|
percentage of patient in each group in which one or more adenoma(s) are detected.
|
during colonoscopy
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：A.A.M. Masclee, Prof. MD、Maastricht University Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年9月14日
初级完成 (实际的)
2019年11月28日
研究完成 (实际的)
2019年11月28日
研究注册日期
首次提交
2018年9月14日
首先提交符合 QC 标准的
2018年9月17日
首次发布 (实际的)
2018年9月19日
研究记录更新
最后更新发布 (实际的)
2019年12月5日
上次提交的符合 QC 标准的更新
2019年12月4日
最后验证
2019年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.