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临床试验/NCT02656602
NCT02656602已完成不适用

Computer-assisted Instruction Before Colonoscopy is as Effective as Nurse Counselling, a Controlled Trial (PAVO-E-EDUC)

Govert Veldhuijzen0 个研究点目标入组 385 人开始时间: 2013年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
385
主要终点
Bowel Cleanliness during colonoscopy measured with the Ottowa Bowel Preparation Scale

研究概览

简要总结

Better patient education prior to colonoscopy improves adherence to instructions for bowel preparation and leads to cleaner colons. The hypothesis of this trial is that computer assisted instruction (CAI) using video and 3D animations can maximize the effectiveness of nurse counselling and consequently improves bowel cleanliness. Furthermore, CAI will positively influence the patient experience.

Adults referred for colonoscopy were included in a Dutch large volume endoscopy unit. Exclusion criteria were illiteracy in Dutch and audiovisual handicaps. Patients were prospectively divided into two groups, one receiving nurse counselling and one receiving CAI and a nurse contact before colonoscopy. The main outcome, cleanliness of the colon during examination, was measured with the Ottawa Bowel Preparation Scale (OBPS) and the Boston Bowel Preparation Scale (BBPS). Patient comfort and anxiety were assessed at multiple time points: directly after the instruction and one hour before colonoscopy. Comfort was rescored 2 hours after colonoscopy. We also tested knowledge and comprehension one hour before colonoscopy. Statistical analyses included Mann-Whitney.

详细描述

To conduct the study, a prospective single center endoscopist blinded controlled design was used.

Patients Consecutive patients older than 18 years referred for elective colonoscopy were included from March 2013 until November 2013 in a single large volume endoscopy center (over 4000 colonoscopies/year) in the greater Amsterdam Area in the Netherlands. Exclusion criteria were illiteracy in Dutch and audiovisual/mental handicaps.

Study design After informed consent was obtained, patients were divided in two groups: the control group received nurse counselling and the intervention group received computer assisted instruction (CAI). Next, patients scored comfort ("How comfortable are you?") and patient anxiety ("How anxious are you)"on a 5-point Likert scale. (T1) After this, the CAI group had a contact with a trained endoscopy nurse for practical matters like bridging in anticoagulant therapy, insulin dosage calculation and scheduling of the colonoscopy. Next, patients were scheduled for their colonoscopies, maximum 6 weeks after the counselling session.

One hour prior to colonoscopy patients scored comfort and anxiety on the 5-point Likert scale. Also patient knowledge and comprehension was tested in a 10-question survey on the provided counselling information (T2).

Post-colonoscopy, patients re-scored comfort on the 5-point Likert scale (T3). During colonoscopy, the endoscopist assessed the bowel cleanliness with the Boston Bowel Preparation Scale (BBPS). For more subtle differences the Ottawa Bowel Preparation Scale (OBPS) was used.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
Single (Care Provider)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients >18 years who were referred for colonoscopy

排除标准

  • Illiteracy in Dutch and audiovisual or mental handicaps

结局指标

主要结局

Bowel Cleanliness during colonoscopy measured with the Ottowa Bowel Preparation Scale

时间窗: During colonoscopy

Bowel Cleanliness during colonoscopy measured by the endoscopist. The tool used was the Ottowa Bowel Preparation Scale (Cumulative score of three bowel segments, 0 is excellent, 4 is poor. Two points can be added for fluid residue in the complete colon. Total 14-point scale, ranging from 14=completely unprepared, 0=perfect).

Bowel Cleanliness during colonoscopy measured with the Boston Bowel Preparation Scale

时间窗: During colonoscopy

Bowel Cleanliness during colonoscopy measured by the endoscopist. The tool used was the Boston Bowel Preparation Scale (Cumulative score of three bowel segments, graded 0-3. Total 10-point scale, ranging from 0=unsatisfactory, 9=excellent).

次要结局

  • Patient Comfort was measured in a five-point Likert scale(Multiple time points: in the hour after instruction, one hour before colonoscopy and two hours after colonoscopy)
  • Knowledge and comprehension prior to colonoscopy was measured in a 10 questions knowledge test(One hour before colonoscopy)
  • Anxiety was measured in a five-point Likert scale(Multiple time points: in the hour after instruction and one hour before colonoscopy)

研究者

发起方
Govert Veldhuijzen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Govert Veldhuijzen

Resident Gastroenterology

Medical Center Alkmaar

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