NCT02656602

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Status
completed

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

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

9 months

First QC Date

January 11, 2016

Last Update Submit

January 14, 2016

Conditions

Keywords

Computer Assisted InstructionPatient CounsellingEndoscopy

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 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.

Other: Computer Assisted Instruction

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.

Also known as: MEx (Medical Experience)
Computer Assisted Instruction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

  • Michael Klemt-Kropp, MD PhD

    Medical Centre Alkmaar

    PRINCIPAL INVESTIGATOR

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