Effect of the Additional Use of a QR Code for More Effective Patient Education and High-quality Bowel Preparation in the Outpatient Setting
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Polyp detection rate (PDR)
研究概览
简要总结
Patients presenting for colonoscopy at one of the participating centers will be asked to participate in the present study after careful evaluation of inclusion and exclusion criteria. Before inclusion, all patients have to sign the written informed consent. All participating patients will receive PLENVU, a well-known and approved bowel preparation agent. Patients are randomly assigned in two groups. Patients in group 1 are informed in traditional way on how to use the bowel preparation agent. This way includes discussion with the physician and nurse on how to use the bowel preparation agent and a written documentation, highlighting the individual steps again. Patients in group 2 will receive in addition a QR-code referring to an App, available for free in all App stores, explaining to the patient in detail when and how to use the bowel preparation agent. The patient is receiving the same questionnaire (please see attached) in both groups and asked to bring the filled form on the day of the examination. Endoscopy is performed in standard way and effectiveness of the bowel preparation is specifically highlighted by the physician on the documentation report. Finally, data is analyzed regarding effectiveness of the QR code regarding patient satisfaction, acceptability and quality of the bowel preparation.
详细描述
Patient education is of paramount importance for high acceptance and an adequate bowel preparation. Using the QR code directly referring to the App for bowel preparation with PLENVU might accelerate the discussion between the medical doctor and the patient and might also improve the acceptance rate of the patients for the bowel preparation finally leading to a more enhanced and effective bowel-preparation.
Patients undergoing screening or surveillance endoscopy will be prospectively included and randomly assigned to one of the following groups: Group 1: App; Group 2: no-App Study end points addressed below are prospectively assessed and evaluated for any significant changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Screening or surveillance colonoscopy
- •Age 18-85 years
- •Written informed consent
排除标准
- •• Pregnancy or lactating
- •Lower gastrointestinal bleeding with hemodynamic instability
- •Bowel obstruction
- •Not sufficiently corrected anticoagulation disorders
- •Plenvu must not be taken:
- •if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medicine;
- •if you have a blockage (obstruction) in the digestive tract.
- •if you have a breakthrough (perforation) in the wall of the digestive tract;
- •if you suffer from intestinal obstruction (Ileus);
- •if you suffer from a disturbance of gastric emptying (e.g. gastroparesis, gastric retention);
- •if you suffer from phenylketonuria. Phenylketonuria is a congenital metabolic disease in which phenylalanine cannot be processed by your body. Plenvu contains aspartame as a source of phenylalanine;
- •if you suffer from glucose-6-phosphate dehydrogenase deficiency;
- •if you suffer from acute colon enlargement (toxic megacolon).
- •Warnings and precautions
- •o You should tell your doctor about the following circumstances before taking Plenvu:
- •if you have heart problems and/or arrhythmias;
- •if you have kidney problems and/or suffer from dehydration;
- •if you have stomach or intestinal problems, including intestinal inflammation;
- •if you have difficulty or discomfort when swallowing liquids;
- •if you have high or low levels of electrolyte (e.g. sodium, potassium);
- •if you have other diseases (e.g. convulsions).
- •Pregnancy and lactation o There are no data on the use of Plenvu during pregnancy or lactation and is therefore not recommended.
研究组 & 干预措施
QR Code
Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy Guidelines. In Addition, this Group will receive a health app for better preparation and more Information regarding preparation and endoscopy itself.
干预措施: Plenvu (Drug)
no QR Code
Patients will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy Guidelines. This Group will have no app and will have to receive Information in traditional ways.
干预措施: Plenvu (Drug)
结局指标
主要结局
Polyp detection rate (PDR)
时间窗: 1 day
How many polyps will be detected during endoscopy
Adenoma detection rate (ADR)
时间窗: 1 day
How many adenomas will be detected during endoscopy
Boston Bowel Preparation Standard (BBPS)
时间窗: 1 day
Bowel preparation according to international Standard, 1 is bad, 9 is very good, how many patients can Achieve BBPS with 9?
time exposure to explain bowel preparation
时间窗: 1 day
How much time will patients Need for preparation and how much time for discussing with the doctors
次要结局
- Number of patients who are satisfied with preparation(up to 1 month)
- cecal intubation rate(1 day)
- procedure time(3 hours)
- Number of patients who Accept to repeat the examination (surveillance)(up to 1 month)
研究者
Prof. Helmut Neumann
University Professor Dr. med.
Johannes Gutenberg University Mainz