Evaluation of Improvement of Colonoscopy Preparation by Using a SPA
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Quality of Bowel preparation
研究概览
简要总结
This study evaluates the impact of a SPA on Quality of bowel preparation for colonoscopy. Half of the patients receive regular paper based information on colonoscopy preparation (control), while the other half will use an additional SPA for colonoscopy preparation (coloprAPP).
详细描述
Preparation for colonoscopy is perceived as a major impediment to participate in CRC screening colonoscopy. Hence, inadequate bowel preparation is reported in up to 25% of all patients undergoing colonoscopy.
Although the quality of bowel preparation is influenced by various factors, it largely depends on patient´s compliance regarding instructions on purgatives and diet. Therefore reinforced education and guidance is a valuable tool to improve bowel preparation.
A rapidly increasing number of individuals worldwide use smartphones in their daily life. Application of this new technology into patient education could facilitate and empower the patient guidance. In this study patients either receive regular information on colonoscopy preparation (paper-based) or download a SPA for reinforced reminding of the steps of colonoscopy preparation. Objective of this study is to measure the impact of a SPA on quality of bowel preparation.
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
- Double (Care Provider, Investigator)
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
- •smartphone
- •outpatient appointment for colonoscopy
- •CRC Screening, surveillance
排除标准
- •no smartphone
- •>ASA 3 (no possibility for outpatient colonoscopy)
研究组 & 干预措施
Control group
Regular colonoscopy preparation paper based information provided
ColoprAPP group
Regular colonoscopy preparation paper based information provided plus usage of a downloaded SPA (ColoprAPP) as a reminder system for colonoscopy preparation
干预措施: ColoprAPP (Device)
结局指标
主要结局
Quality of Bowel preparation
时间窗: During colonoscopy procedure
Measurement of bowel cleanliness by Boston Bowel preparation Scale (BBPS) with special regard on percentage of insufficient results of bowel preparation
次要结局
- Adenoma detection rate(histological analysis after colonoscopy up to 10 days (d10))
- Acceptance of patients towards bowel preparation procedure(at colonoscopy appointment (day 0))
研究者
Alexander Meining
Head of Endoscopy department
University of Ulm