Design of a Mobile Application to Improve the Quality of Colonoscopy and Its Implementation in Colorectal Cancer Screening Program: a Randomized Multicenter Study (PrepColon APP Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 470
- 试验地点
- 2
- 主要终点
- Compliance with the diet and intake of laxatives with the use of a mobile application
研究概览
简要总结
Colonoscopy is the gold standard for the diagnosis and resection of preneoplastic lesions, allowing the prevention of colon cancer. A colonoscopy is more efficient with proper preparation of the colon, as it allows for a higher rate of adenoma detection and cecal intubation. In routine practice, up to 30% of colonoscopies are poorly prepared and 11% of patients do not show up for their appointment. Adenomas not visualized in the initial colonoscopy due to poor preparation reached 68% and the rate of undetected cancers was 66.7%. A proper colon cleanse is conditioned by different factors; among them, failure to comply with the diet and take laxatives poses 5 times the risk of having a deficient colon preparation. The purpose of our study is the design and implementation of an app that facilitates the preparation of colonoscopy and evaluates its impact on compliance with diet and laxative intake.
详细描述
STUDY DESIGN AND METHODS
Study Design:
Phase 1: Design of the mobile application (APP): The APP will be designed in a participatory manner by the research team of the project, formed by doctors, nurses, statisticians and telecommunications engineers. The application should be usable with both Android and iOS devices, so we will use the Flutter framework to build apps for different platforms with a single code base.
When arranging a colonoscopy, the patient will install the APP on their mobile phone and indicate the date and time of the test. The APP will be responsible for supporting the preparation of the colon cleansing, for which, in addition to being able to visualize the corresponding information, it will make use of notifications to show diet reminders and laxative intakes.
More specifically, these could be some notifications:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
Patients who agree to participate in the study are randomized by a 1:1 block computer program (an attempt will be made to balance the groups according to the type of laxative) into two groups: group A: control group, which receives the standard information given in writing, and group B: APP group, which receives the standard information together with the mobile application individually adapted to the scheduled colonoscopy appointment and the type of laxative.
Patients scheduled for a screening colonoscopy will be contacted by telephone, those who agree to participate will be scheduled with the nurse, after giving their consent they are randomized. Group B will indicate how to download the APP and its management. The endoscopist performing the examination is blind for randomization and will assess colon cleansing according to the Boston Bowel Scale (Lai EJ. et al Gastroinest Endosc 2009).
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-Subjects between 50-69 years old from the CRC screening program with FIT (>100ng/ml).
- •Informed consent granted in writing
排除标准
- •Refusal to give informed consent.
- •Those who do not have a smartphone with a minimum version of the operating system (Android 4.4 or iOS 14, which cover more than 99% of the terminals in use)
- •Symptomatic patients
- •Subjects at elevated risk of CRC due to family history or inherited polyposis diseases or inflammatory bowel disease
研究组 & 干预措施
Control group
which receives the standard information given in writing,
APP group
Group which receives the standard information together with the mobile application individually adapted to the scheduled colonoscopy appointment and the type of laxative.
干预措施: Mobile application for colonoscopy preparation instructions (Other)
结局指标
主要结局
Compliance with the diet and intake of laxatives with the use of a mobile application
时间窗: at the moment of the procedure
Questionnaire about ASSESSMENT OF DIET COMPLIANCE (number of portions 0-\>2, higher points means worse outcome): Have you followed the diet without fiber the 3 days prior to preparation: YES/ NO * Have you eaten fruits, vegetables and legumes? number of portions 0 1 2 \>2 * Have you eaten whole grain products? number of portions 0 1 2 \>2 * Have you eaten meats and sausages? number of portions 0 1 2 \>2 * Have you eaten blue fish? number of portions 0 1 2 \>2 * Have you eaten nuts? number of portions 0 1 2 \>2 * Have you eaten anything solid in the last 24 hours? yes/ no
Evaluate the quality of colon cleansing with mobile application as an experimental factor
时间窗: at the moment of the procedure
The endoscopy will assess colon cleansing according to the Boston Bowel Scale (BBPS) uses a 4-point rating system (0-3) applied to each of the 3 segments of the colon (right, transverse, left) to assess colon cleanliness during the withdrawal phase of colonoscopy, after all cleaning maneuvers have been performed. (0 worse outcome and 3 best outcome)
Assessment of the usability of the APP
时间窗: at the moment of the procedure
A questionare: System Usability scale (SUS), ten question about usability with Five responses ranging from Strongly Agree to Strongly Disagree
Compliance with the laxative intake with the use of the mobile application
时间窗: At the moment of the procedure
Questionnaire to EVALUATE COMPLIANCE WITH TAKING THE LAXATIVE: questions like at • --Type of laxative: (name): * Colonoscopy appointment (time) Morning / Afternoon * Start of taking the laxative: time: * End of taking the laxative (How many hours ago did you finish taking the laxative before the appointment? * Have you taken all of the laxative? * How much liquid have you drunk? * How many shots have you done it in? How much liquid does each drink?
次要结局
- Assessment of the difficulty of the preparation instructions(at the moment of the procedure)
- Evaluate colonoscopy quality indicators:(at the moment of the procedure and after one month with the histological results)
- Evaluate attendance at the scheduled colonoscopy appointment(at the moment of the colonoscopy)
- Evaluate colonoscopy quality indicators(at the moment of the colonoscopy)
研究者
Mª Henar Núñez Rodriguez, MD PhD
Principal Investigator
Hospital del Rio Hortega