Development and Validation of a Smartphone App to Improve the Quality of Bowel Preparation for Colonoscopy
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of patients with Ottawa Bowel Preparation Quality Scale Score less than 8.
研究概览
简要总结
This clinical trial is a single-center, single-blind, prospective, randomized, controlled, pilot study comparing the efficacy of a smartphone app and verbal/written patient instructions to evaluate the impact of a mobile software application in reducing the failure rate of outpatient colonoscopy by improving the quality of bowel preparation through enhanced patient adherence. The target sample size is 20 patients. The primary outcome measure will be the percentage of patients with Ottawa Bowel Preparation Quality Scale Score less than 8 during the colonoscopy procedure. The secondary outcome measures will be the overall improvement in adherence according to a specially developed Adherence Score and degree of patient satisfaction with the smartphone app for bowel preparation compared to the standard method of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Outpatient, elective, screening colonoscopy; Age from 20 to 50 years; Having their first colonoscopy; Owning an Android-based smartphone with or without always-on internet connection; Having the ability to download and configure regimen personalization settings and skillfully use the app; Having the ability to read and understand English or Kannada or Malayalam very well; Having and using western-style toilet bowl in their home; Written informed consent.
排除标准
- •Patients with severe comorbidities (congestive heart failure, chronic renal disease, ascites, etc.); History of prior colonoscopies (experience in bowel preparation); Patients taking iron supplements; History of chronic drug use (constipation drugs, laxatives, or anti-diarrheal agents); Pregnancy or lactation; Known inflammatory bowel disease; Presence of psychotic or major mental illness or intellectual faculties insufficient to use a smartphone app; Known or suspected poor compliance; Allergy to the purgative solution; History of colorectal surgery; Patients with planned endoscopic therapy;.
结局指标
主要结局
Percentage of patients with Ottawa Bowel Preparation Quality Scale Score less than 8.
时间窗: At the time of colonoscopy.
次要结局
- Overall improvement in adherence according to a specially developed Adherence Score.(At the time of patient colonoscopy visit.)
- Degree of patient satisfaction with the smartphone app for bowel preparation compared to the standard method of care.(At the time of patient colonoscopy visit.)