Exploring the Clinical Value of an AI-Assisted Patient Self-Assessment App for Bowel Preparation: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 524
- 主要终点
- Compare the bowel preparation quality between the app group and the control group.
研究概览
简要总结
The quality of bowel preparation hinges on how well patients follow the prep-drug regimen, so intensive education is essential. Phone calls, texts, short videos, and mini-programs have all been shown to boost compliance and improve prep quality. Still, we also need a way to spot-early-those patients who are likely to prep poorly so we can step in with a rescue plan.
In our pilot work the investigators built an AI-assisted mini-program that lets patients photograph their effluent and get an instant quality read-out. The single-center RCT showed excellent performance. Because these findings came from one center, the investigators are now launching a multicenter study to test the tool more broadly. Patients will use the AI mini-program at home; if the algorithm predicts inadequate prep it will prompt them to come in early or alert staff so the investigators can initiate a rescue protocol and, ultimately, improve bowel-cleansing quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Age ≥ 18 years
- •Undergoing colonoscopy at a participating site
- •Able to defecate in a toilet (or in a setting where stool characteristics can be observed) after taking the bowel-prep solution
- •Proficient in using a smartphone
- •Willing to participate voluntarily
排除标准
- •American Society of Anesthesiologists (ASA) class III or IV;
- •Gastric-outlet or intestinal obstruction; ③ Active gastrointestinal bleeding; ④ Enterostomy (colostomy/ileostomy); ⑤ Status post total colectomy.
研究组 & 干预措施
The App group
After taking the bowel-prep solution, patients in the app group are instructed to photograph their final stool in the toilet and upload the image through our smartphone app. The AI algorithm immediately scores the prep quality. If the image is rated "poor" or "inadequate," the app displays an alert advising the patient to come to the hospital early or contact clinical staff; clinical staffs then review the photo and decide whether a rescue preparation is needed. The standard rescue was an additional packet of polyethylene glycol. If the image is rated "adequate," the patient is told the prep is acceptable and should proceed to the appointment, where clinical staffs will use the uploaded photo to confirm eligibility for colonoscopy.
干预措施: The app group (Other)
The control group
The control group followed the conventional procedure: before the examination, clinical staffs asked questions and relied on the patient's verbal description of their stool to judge the adequacy of bowel preparation. If the prep was deemed inadequate, the standard rescue was an additional packet of polyethylene glycol.
结局指标
主要结局
Compare the bowel preparation quality between the app group and the control group.
时间窗: From enrollment to 30 days after the procedure.
The rate of adequate and excellent bowel preparation.
次要结局
- Evaluate the diagnostic performance of the app-based assessment.(From enrollment to 30 days after the procedure.)
- cecal intubation rate(From enrollment to 30 days after the procedure.)
- cecal intubation time(From enrollment to 30 days after the procedure.)
- withdrawal time (excluding polypectomy and biopsy)(From enrollment to 30 days after the procedure.)
- polyp-detection rate (PDR), adenoma-detection rate (ADR), advanced-adenoma-detection rate (aADR)(From enrollment to 30 days after the procedure.)
- use of rescue preparation, rate of rescheduled examinations due to inadequate preparation(From enrollment to 30 days after the procedure.)
- clinical staffs' assessment time(From enrollment to 30 days after the procedure.)
- User satisfaction score(From enrollment to 30 days after the procedure.)
- post-procedural adverse events(From enrollment to 30 days after the procedure.)