ColonoscopyPAVO-E-EDUCNCT02656602
Computer-assisted Instruction Before Colonoscopy is as Effective as Nurse Counselling, a Controlled Trial
A study testing Computer Assisted Instruction in people with Colonoscopy and Education, Patient, run by Govert Veldhuijzen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy, Education, Patient, eHealth
- What is being tested?
- Computer Assisted Instruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years who were referred for colonoscopy
Who cannot join
- Illiteracy in Dutch and audiovisual or mental handicaps
About this study
Official title: Computer-assisted Instruction Before Colonoscopy is as Effective as Nurse Counselling, a Controlled Trial (PAVO-E-EDUC)
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.
Read the detailed description
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.
Computer assisted instruction As intervention an interactive CAI was designed, according to current best practices, like good accessibility, plain language and engaging the user. Therefore the information was presented stepwise. The CAI consisted of a web-based 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 informative elements, especially mandatory for informed consent for colonoscopy (risks, alternatives) were included.
Outcomes The primary outcome was cleanliness of the colon during examination as assessed by the OBPS and the BBPS. The secondary outcomes were patient comfort, anxiety and knowledge and comprehension.
Statistical analyses The sample size of 350 provides 80% power, with a two-tailed α of 0.05, to detect an increase in the primary outcome measure from 6.0 in the control group to 6.3 in the experimental group.
All analyses were performed using SPSS version 20.0 for Windows (SPSS Inc., Chicago, IL, USA). Descriptive statistics were used to describe baseline information including frequency count, percentage and mean ±standard deviation. Further analyses included the chi-square test, independent t-test and Mann-Whitney. P-values under 0.05 were regarded statistically significant.
Ethical considerations The study was approved by the ethical and executive board of the institute.
- Conditions
- Colonoscopy, Education, Patient, eHealth
- Being tested
- Computer Assisted Instruction
- Keywords
- Computer Assisted Instruction, Patient Counselling, Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Assisted InstructionOther
Also called MEx (Medical Experience)
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.
| Study group | Role | What they receive |
|---|---|---|
| Nurse Counseling | No intervention | A trained endoscopy nurse provided patients with all information on their scheduled colonoscopy. |
| Computer Assisted Instruction | Experimental | 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. Receives: Other: Computer Assisted Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: During colonoscopy
Secondary outcomes (3)
Patient Comfort was measured in a five-point Likert scale
Comfort regarding the colonoscopy was measured in a five-point Likert scale ("How comfortable are you") after the moment of informing (nurse and CAI), prior to colonoscopy and after colonoscopy
Measured: 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
Anxiety regarding the colonoscopy was measured in a five-point Likert scale ("How anxious are you") after the moment of informing (nurse and CAI) and prior to colonoscopy.
Measured: 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
Comprehension before colonoscopy was measured in a 10 questions knowledge test on information prior provided.
Measured: One hour before colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startFeb 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Govert Veldhuijzen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Govert Veldhuijzen, Medical Center Alkmaar
- Investigators
- Michael Klemt-Kropp, MD PhD, Principal investigator, Medical Centre Alkmaar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656602
- Sponsor's protocol ID
- L013-011
- Acronym
- PAVO-E-EDUC
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-assisted Instruction Before Colonoscopy is as Effective as Nurse Counselling, a Controlled Trial (PAVO-E-EDUC)
- ClinicalTrials.gov ID
- NCT02656602
- Acronym / sponsor ID
- PAVO-E-EDUC / L013-011
- Conditions
- Colonoscopy, Education, Patient, eHealth
- Keywords
- Computer Assisted Instruction, Patient Counselling, Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Govert VeldhuijzenUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Computer assisted instruction As intervention an interactive CAI was designed, according to current best practices, like good accessibility, plain language and engaging the user. Therefore the information was presented stepwise. The CAI consisted of a web-based 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 informative elements, especially mandatory for informed consent for colonoscopy (risks, alternatives) were included.
Outcomes The primary outcome was cleanliness of the colon during examination as assessed by the OBPS and the BBPS. The secondary outcomes were patient comfort, anxiety and knowledge and comprehension.
Statistical analyses The sample size of 350 provides 80% power, with a two-tailed α of 0.05, to detect an increase in the primary outcome measure from 6.0 in the control group to 6.3 in the experimental group.
All analyses were performed using SPSS version 20.0 for Windows (SPSS Inc., Chicago, IL, USA). Descriptive statistics were used to describe baseline information including frequency count, percentage and mean ±standard deviation. Further analyses included the chi-square test, independent t-test and Mann-Whitney. P-values under 0.05 were regarded statistically significant.
Ethical considerations The study was approved by the ethical and executive board of the institute.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Counseling | No intervention | –A trained endoscopy nurse provided patients with all information on their scheduled colonoscopy. |
| Computer Assisted Instruction | Experimental | Other: Computer Assisted InstructionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients >18 years who were referred for colonoscopy
Key exclusion criteria (1 listed)
- Illiteracy in Dutch and audiovisual or mental handicaps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer Assisted InstructionAlso: MEx (Medical Experience)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. | Other | Computer Assisted Instruction |
Primary outcome
Bowel Cleanliness during colonoscopy measured with the Boston Bowel Preparation Scale
Time frame: 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).
Bowel Cleanliness during colonoscopy measured with the Ottowa Bowel Preparation Scale
Time frame: 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).
3 secondary outcomes
Patient Comfort was measured in a five-point Likert scale
Time frame: 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
Time frame: 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
Time frame: One hour before colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Klemt-Kropp, MD PhD principal investigator
Medical Centre Alkmaar
Questions about this trial
What is this clinical trial studying?
A study testing Computer Assisted Instruction in people with Colonoscopy and Education, Patient, run by Govert Veldhuijzen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bowel Cleanliness during colonoscopy measured with the Boston Bowel Preparation Scale (time frame: During colonoscopy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2016; AzTrials last refreshed its copy on 31 Oct 2026.