Bowel DysfunctionNCT02013505
A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy
A study testing Educational video in people with Bowel Dysfunction, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
The investigators hypothesised that a video based patient education will help patients understand the process of colon cleansing prior to a colonoscopy procedure and hence will result in clean colons that will may help physician perform a better quality examination. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Dysfunction
- What is being tested?
- Educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Nov 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Subjects who have the ability to give consent
- Subjects who are scheduled for colonoscopy as out patient
- Subjects consenting to participate in the study
- Subjects who are able to read and understand English
Who cannot join
- < 18 years age
- Subjects from whom consent cannot be obtained for any reason.
- Subjects who are scheduled for colonoscopy as in patient
- Subjects who are scheduled for colonoscopy within a time period or a situation where the educational material cannot be properly delivered to the study participant.
- Subjects who are advised to undergo bowel prep for more than one day.
- Subjects undergoing bowel prep with medications other than Colyte.
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- Subjects who do not have access to equipment to watch the video (TV/CD player)
- Pregnant patients
- Prisoners
- Subjects who are not able to read or understand English.
- (j)Subjects who had bowel resection surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy.
The investigators hypothesised that a video based patient education will help patients understand the process of colon cleansing prior to a colonoscopy procedure and hence will result in clean colons that will may help physician perform a better quality examination.
Read the detailed description
After obtaining consent over phone, the investigators randomly assigned assigned participants to receive either the standard paper based instructions or receive an educational video in addition to the standard paper based instruction. Physicians performing the procedure were blinded to this assignment. The investigators obtained information relating to the cleanliness of the colon as noted during the colonoscopy examination. The investigators obtained this information from the colonoscopy reports. The investigators also obtained information regarding colon polyps,wanting to see if there is any difference in the number of patients in whom adenomatous polyps were detected.
Outcome measures:
Primary Out come:
1.Quality of bowel preparation
Secondary outcome:
- Adenoma detection rate
- Rate of incomplete procedures due to poor bowel prep.
- Conditions
- Bowel Dysfunction
- Being tested
- Educational video
- Keywords
- Colonoscopy
- Medical subject headings
- Intestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
An educational video was developed based on the current paper instructions for bowel preparation. The video included a physician explaining the process, using more images and short clip videos of the example. The script of the video was approved by the patient education department of the University Hospital and language adjusted to 6th grade level.
| Study group | Role | What they receive |
|---|---|---|
| Instructions printed on a paper. | No intervention | There will be no intervention. |
| Paper and video instructions | Experimental | .Instructions printed on paper and a educational video. Receives: Other: Educational video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of bowel preparation
Quality of bowel preparation at the time when the colonoscopy procedure is performed as reported by the physician performing the colonoscopy.
Measured: At the time of colonoscopy
Secondary outcomes (1)
Adenoma detection rate
Number of patients undergoing screening colonoscopy for average risk in whom an adenoma was detected.
Measured: At time of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Study expired; Investigator left facility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dilip Bearelly, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013505
- Sponsor's protocol ID
- 1203774
- Status last verified
- Jul 2023
- First submitted
- 11 Dec 2013
- Last updated
- 28 Jul 2023
- 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 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validated Educational Video Intervention Improves the Quality of Bowel Preparation for Colonoscopy.
- ClinicalTrials.gov ID
- NCT02013505
- Acronym / sponsor ID
- 1203774
- Conditions
- Bowel Dysfunction
- Keywords
- Colonoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study expired; Investigator left facility.
- Enrolment
- 298 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Dec 2013 (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.
The investigators hypothesised that a video based patient education will help patients understand the process of colon cleansing prior to a colonoscopy procedure and hence will result in clean colons that will may help physician perform a better quality examination.
Detailed description
After obtaining consent over phone, the investigators randomly assigned assigned participants to receive either the standard paper based instructions or receive an educational video in addition to the standard paper based instruction. Physicians performing the procedure were blinded to this assignment. The investigators obtained information relating to the cleanliness of the colon as noted during the colonoscopy examination. The investigators obtained this information from the colonoscopy reports. The investigators also obtained information regarding colon polyps,wanting to see if there is any difference in the number of patients in whom adenomatous polyps were detected.
Outcome measures:
Primary Out come:
1.Quality of bowel preparation
Secondary outcome:
- Adenoma detection rate
- Rate of incomplete procedures due to poor bowel prep.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instructions printed on a paper. | No intervention | –There will be no intervention. |
| Paper and video instructions | Experimental | Other: Educational video.Instructions printed on paper and a educational video. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Subjects who have the ability to give consent
- Subjects who are scheduled for colonoscopy as out patient
- Subjects consenting to participate in the study
- Subjects who are able to read and understand English
Key exclusion criteria (11 listed)
- < 18 years age
- Subjects from whom consent cannot be obtained for any reason.
- Subjects who are scheduled for colonoscopy as in patient
- Subjects who are scheduled for colonoscopy within a time period or a situation where the educational material cannot be properly delivered to the study participant.
- Subjects who are advised to undergo bowel prep for more than one day.
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 |
|---|---|---|
| Educational videoAn educational video was developed based on the current paper instructions for bowel preparation. The video included a physician explaining the process, using more images and short clip videos of the example. The script of the video was approved by the patient education department of the University Hospital and language adjusted to 6th grade level. | Other | Paper and video instructions |
Primary outcome
Quality of bowel preparation
Time frame: At the time of colonoscopy
Quality of bowel preparation at the time when the colonoscopy procedure is performed as reported by the physician performing the colonoscopy.
1 secondary outcome
Adenoma detection rate
Time frame: At time of colonoscopy
Results and safety
The study was stopped early (reason given: Study expired; Investigator left facility.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- 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.
Dilip Bearelly, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Bowel Dysfunction, run by University of Missouri-Columbia at 1 site in United States.
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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: Study expired; Investigator left facility.). Results are not available in the source record.
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?
Quality of bowel preparation (time frame: At the time of colonoscopy). 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 28 Jul 2023.