Computer-assisted Instruction Before Colonoscopy is as Effective as Nurse Counselling, a Controlled Trial
PAVO-E-EDUC
1 other identifier
interventional
385
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 11, 2016
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedJanuary 15, 2016
January 1, 2016
9 months
January 11, 2016
January 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Bowel Cleanliness during colonoscopy measured with the Boston Bowel Preparation Scale
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).
During colonoscopy
Bowel Cleanliness during colonoscopy measured with the Ottowa Bowel Preparation Scale
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).
During colonoscopy
Secondary Outcomes (3)
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
Anxiety was measured in a five-point Likert scale
Multiple time points: in the hour after instruction and one hour before colonoscopy
Knowledge and comprehension prior to colonoscopy was measured in a 10 questions knowledge test
One hour before colonoscopy
Study Arms (2)
Nurse Counseling
NO INTERVENTIONA trained endoscopy nurse provided patients with all information on their scheduled colonoscopy.
Computer Assisted Instruction
EXPERIMENTALThe computer assisted instruction consisted of a platform using video mimicking the patient journey with voice-over supported by photo's, 3D animation and instructive texts. The video was presented in short clips, maximal 45 seconds, to maintain the focus of patient. Patient interaction was ascertained by mandatory mouse-click after each item in the CAI.All elements of informed consent for colonoscopy (risks, alternatives) were included.
Interventions
The computer assisted instruction consisted of a platform using video mimicking the patient journey with voice-over supported by photo's, 3D animation and instructive texts. The video was presented in short clips, maximal 45 seconds, to maintain the focus of patient. Patient interaction was ascertained by mandatory mouse-click after each item in the CAI. All elements of informed consent for colonoscopy (risks, alternatives) were included.
Eligibility Criteria
You may qualify if:
- Patients \>18 years who were referred for colonoscopy
You may not qualify if:
- Illiteracy in Dutch and audiovisual or mental handicaps
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Klemt-Kropp, MD PhD
Medical Centre Alkmaar
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Resident Gastroenterology
Study Record Dates
First Submitted
January 11, 2016
First Posted
January 15, 2016
Study Start
February 1, 2013
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
January 15, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share