A Novel Smart Phone Application for Patients Undergoing COLOnoscopic Bowel PREParation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Quality of Bowel Preparation
研究概览
简要总结
This is a randomized controlled trial designed to assess the efficacy of a novel smartphone application as an automated reminder tool in improving the quality of bowel preparation for patients undergoing outpatient colonoscopies. The investigators will be comparing the smartphone application to traditional instructions for bowel preparation. The quality of bowel preparation will be assessed using the Ottawa and Aronchick bowel preparation scales.
详细描述
This is a randomized controlled trial designed to assess the efficacy of a novel smartphone application as an automated reminder tool in improving the quality of bowel preparation for patients undergoing outpatient colonoscopies at an academic teaching hospital in Kingston, Ontario.
The intervention under investigation is the use of a novel smart phone application which serves as an automated reminder system for patients undergoing outpatient colonoscopies. The application requires the patients to enter the date and time of the colonoscopy appointment and automatically populates the patients' phones with calendar reminders as well as pre-recorded messages regarding cessation of solid food intake, the need for clear fluid intake, as well as timing of their bowel regimens starting 7 days prior.
The design of this study is a prospective, randomized controlled trial with single blinding (endoscopist). Eligible participants will be randomized into either the control (routine paper instructions) or the intervention group (smart phone application). Those who are randomized into the intervention group will be provided with specific instructions to download and setup the smart phone application at least 7 days prior to their scheduled appointment. Upon arrival to their appointment, participants in both groups will be asked to complete a survey confirming the adherence to either paper instructions or instructions provided by the smart phone application.
The primary outcome of this study is the adequacy of the bowel preparation, as assessed by using the Ottawa and Aronchick bowel preparation scales, which have been previously validated and are in common usage for colonoscopy procedures. Secondary outcomes include rate of polyp detection, rate of cecal intubation, and patient reported ease of use and adherence to the bowel regimen instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients will be aware of the arm they were assigned to. Colonoscopist performing the colonoscopy will be masked to the intervention and will be providing the assessment of the quality of bowel preparation.
The investigators will be masked to the assignment.
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
- •Access to smart phone with the ability to download smart phone application
- •Outpatient screening colonoscopy
排除标准
- •Patient refusal
- •Bowel preparation other than pico-salax or GoLytely
- •Urgent/Emergent Colonoscopy
- •Patient requiring combined upper and lower endoscopic evaluation
- •No access to smart phone or inability to download smart phone application
- •Surveillance colonoscopy for previously resected cancer
- •Inflammatory bowel disease
结局指标
主要结局
Quality of Bowel Preparation
时间窗: At time of colonoscopy
The quality of bowel preparation as assessed by the validated Boston and Aronchick bowel preparation scales
次要结局
- Patient reported adherence to bowel preparation instructions(At time of colonoscopy)
- Adenomatous polyp detection(At time of colonoscopy)
- Cecal Intubation(At time of colonoscopy)
研究者
Sunil Patel
Assistant Professor and Attending Surgeon
Queen's University
