Efficacy of Enhanced Focused Education and Counseling on Adequacy of Mechanical Bowel Preparation Among High-Risk Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Boston Bowel Preparation Scale (BBPS) Total Score
研究概览
简要总结
The goal of this clinical trial is to learn whether enhanced education and counseling can improve bowel preparation before colonoscopy in high-risk patients. The main questions it aims to answer are:
Does enhanced education lead to better bowel cleansing as measured by the Boston Bowel Preparation Scale (BBPS)?
Does it improve patient satisfaction, compliance with instructions, and procedure efficiency?
Researchers will compare an enhanced education program (including counseling, video, booklet, and mobile app) to standard written instructions typically given before colonoscopy.
Participants will:
Be randomly assigned to either the enhanced education group or the standard instruction group
Undergo routine colonoscopy after following the assigned preparation method
Complete short questionnaires about their experience, satisfaction, and willingness to repeat the process
This study is being done at two hospitals in Palestine.
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
- Single (Outcomes Assessor)
盲法说明
Endoscopists scoring bowel preparation using the Boston Bowel Preparation Scale (BBPS) were blinded to the participant's group assignment. Participants and care providers were not masked due to the nature of the intervention.
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
- •Age 18 years or older
- •Undergoing elective colonoscopy
- •Considered high-risk for inadequate bowel preparation, including at least one of the following:
- •Prior abdominal or pelvic surgery
- •Chronic constipation (fewer than 3 bowel movements per week)
- •Use of constipating medications (e.g., opioids, tricyclic antidepressants, calcium channel blockers)
- •Age >65 years
- •Multiple comorbidities (e.g., diabetes, neurologic disorders affecting motility)
- •---------------------------------------------------
排除标准
- •Known allergy or intolerance to bowel preparation agents
- •Severe comorbidities (e.g., decompensated liver disease, severe heart failure)
- •Cognitive impairment or illiteracy preventing understanding of instructions
- •Emergency colonoscopy or known obstructive colorectal disease
研究组 & 干预措施
Enhanced Education Group
Participants in this group received enhanced bowel preparation education. The intervention included:
Face-to-face counseling by trained staff about the importance of bowel prep and how to follow instructions; A 6-minute instructional video explaining dietary restrictions, purgative usage, and procedure timeline; A printed booklet with illustrated step-by-step instructions; and Access to a smartphone app with automated reminders, preparation tracking, and guidance.
All participants used the same bowel cleansing agent (polyethylene glycol-based preparation).
干预措施: Enhanced Education Package for Bowel Preparation (Behavioral)
Enhanced Education Group
Participants in this group received enhanced bowel preparation education. The intervention included:
Face-to-face counseling by trained staff about the importance of bowel prep and how to follow instructions; A 6-minute instructional video explaining dietary restrictions, purgative usage, and procedure timeline; A printed booklet with illustrated step-by-step instructions; and Access to a smartphone app with automated reminders, preparation tracking, and guidance.
All participants used the same bowel cleansing agent (polyethylene glycol-based preparation).
干预措施: Standard Education Leaflet (Other)
Standard Education Group
Participants in this group received standard bowel preparation instructions in the form of a hospital-issued informational leaflet. This leaflet included basic written instructions about dietary restrictions, timing and method of laxative use, and preparation day logistics.
No counseling, video, or app-based support was provided. The same bowel cleansing agent was used in both arms.
干预措施: Standard Education Leaflet (Other)
结局指标
主要结局
Boston Bowel Preparation Scale (BBPS) Total Score
时间窗: During the procedure itself
The BBPS is a validated scoring system to assess bowel cleanliness during colonoscopy. It ranges from 0-9, with three sub-scores (right, transverse, left colon) each scored 0-3. Higher scores indicate better bowel preparation quality. Total BBPS score will be compared between groups.
次要结局
- Cecal Intubation Time(During the procedure itself)
- Patient Satisfaction Score(Within 24 hours after colonoscopy)
- Willingness to Repeat Preparation(Within 24 hours after colonoscopy)
研究者
Mohammed M. H. Hajhamad
MB, BCH (Egypt) DoS (Malaysia) Consultant Surgeon and Endoscopist Head of Department of Continuous Medical Education and Clinical Research - Rafidia Surgical Hospital
An-Najah National University