The Effectiveness of a Customized Mobile Application in Colonoscopy Preparation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Quality of the preparation using the modified Aronshick scale
研究概览
简要总结
Colonoscopy is the preferred procedure to investigate any large-bowel disease in adults and children. In addition, colonoscopy is the current gold standard for colorectal cancer screening due to its high diagnostic capabilities and its unique feature that permits sampling and removal of pathology. For optimal performance and visualization of details, however, an adequate bowel preparation is essential. Inadequate bowel preparation is associated with cancelled procedures, prolonged procedure time, incomplete examination, increased cost and possibly complications, physician frustration and patient anxiety, but most importantly serving to impede colorectal cancer screening and surveillance.
A good bowel preparation would need a solution with a reasonable volume, acceptable taste, minimal diet restrictions, and easy to follow instructions; and would also need patients' adherence to the instructions and diet restrictions. Noncompliance of patients to the diet restrictions, the starting day of diet, the timing of drinking the solution, and other instructions play an important role in rendering the colon preparation inadequate.
Aim: The investigators aim, at assessing the influence of having a reminder mobile application on the compliance and adherence to instructions and diet and consequently on the quality of colon preparation.
Hypothesis: The investigators' hypothesis is that patients having a customized mobile App reminding them systematically about instruction and time of intake of the preparation will have a better adherence to the prep protocol and likely on the quality preparation than those given written and verbal instructions in clinic.
详细描述
This is a randomized controlled trial that will include patients undergoing elective colonoscopy at the American University of Beirut Medical Center. Patients will be randomized into one of two study arms using a computer generated randomization list. 160 patients will be enrolled in total. All patients will be instructed by the study coordinator on the importance of adherence to the protocol in the leaflet emphasizing its importance to the colonoscopy quality. In addition, patients in Arm 2 will be given information about the application features. The application will have push notifications to inform patient on time of start of dietary changes, type of diet, time of preparing the solution, time of drinking the solution, reminder of their appointment, etc. All patients will then be interviewed by the research coordinator to evaluate the adherence to the assigned diet and compliance with the prep protocol as the main outcome and the ease of the application and the patient's attitude towards having such application as secondary outcomes. Based on the results of similar studies that assessed the use of software system to improve compliance, the investigators' sample size was a calculated assuming similar results. Calculations showed that 78 patients per arm will be enough to attain significance. The number 80 was chosen as attrition is presumed to be low. As for the statistical analysis, SPSS version 20.0 will be used for data entry and analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Elective outpatient colonoscopy
- •Consent to the study
- •Owning a smartphone
排除标准
- •Pregnant or lactating women
- •Age less than 18 years
- •Known Inflammatory bowel disease
- •Significant gastroparesis
- •Gastric outlet obstruction
- •Known or suspected bowel obstruction or perforation
- •Phenylketonuria
- •Toxic colitis or megacolon
- •Having a stoma
- •Compromised swallowing reflex or mental status
- •Psychiatric disease or known or suspected poor compliance
- •Severe chronic renal failure (creatinine clearance <30 mL/minute)
- •Severe congestive heart failure (New York Heart Association [NYHA] class III or IV)
- •Dehydration
- •Laxative use or dependency
- •Chronic constipation (<3 spontaneous bm/week)
- •Uncontrolled hypertension (systolic blood pressure ≥170 mm Hg, diastolic blood pressure ≥100 mm Hg)
研究组 & 干预措施
Instruction leaflet
Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed
干预措施: Explanation of paper and application instructions (Other)
Instruction leaflet
Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed
干预措施: Instruction leaflet (Other)
Instruction leaflet
Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed
干预措施: Picoprep solution (Other)
Mobile App
Patients will receive Picoprep solution with an instruction leaflet + Picoprep Mobile App which will be downloaded to their smartphones that has the same information plus a reminder utility
干预措施: Picoprep solution (Other)
Mobile App
Patients will receive Picoprep solution with an instruction leaflet + Picoprep Mobile App which will be downloaded to their smartphones that has the same information plus a reminder utility
干预措施: Instruction leaflet (Other)
Mobile App
Patients will receive Picoprep solution with an instruction leaflet + Picoprep Mobile App which will be downloaded to their smartphones that has the same information plus a reminder utility
干预措施: Mobile App (Other)
Mobile App
Patients will receive Picoprep solution with an instruction leaflet + Picoprep Mobile App which will be downloaded to their smartphones that has the same information plus a reminder utility
干预措施: Explanation of paper and application instructions (Other)
结局指标
主要结局
Quality of the preparation using the modified Aronshick scale
时间窗: Directly after the Colonoscopy
During every colonoscopy a blinded interventionalist will assess the quality of the preparation using the modified Aronshick scale
Questionnaire for adherence to the assigned diet
时间窗: 30 minutes before the Colonoscopy
The research coordinator will ask the patients specific questions to assess their adherence to the assigned diet ( first and second dietary changes)
Questionnaire for compliance with the prep protocol
时间窗: 30 minutes before the Colonoscopy
The research coordinator will ask the patients specific questions to assess their compliance with the prep protocol
次要结局
- Patient satisfaction with the written instructions and mobile application using a visual analogue scale(30 minutes before the Colonoscopy)
- Questionnaire for ease of use of the mobile App(30 minutes before the Colonoscopy)
- Questionnaire for patient willingness to take the same preparation in the future if needed(30 minutes before the Colonoscopy)
研究者
Ala'a Sharara
Professor of Medicine
American University of Beirut Medical Center