Other Surgical ProceduresNCT02906969
Colonoscopy Educational Video Upon Inner City Population
A study testing Colonoscopy Educational Video in people with Other Surgical Procedures, run by Drexel University.
Trial summary
Background: The investigators assessed the use of a colonoscopy instructional video to improve both bowel preparation and education prior to procedure. Preceding studies have been vague, pinning patient education via diagrams and text as both pivotal and useless for compliance in bowel preparations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Other Surgical Procedures
- What is being tested?
- Colonoscopy Educational Video
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Mar 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-85
- undergoing initial outpatient colonoscopy
- willing to participate in and sign consent for this study
- Morning session of colonoscopy procedure
Who cannot join
- Patients were excluded if they had dementia or
- cognitive impairment or
- if they did not have a pre-procedural office visit.
About this study
Official title: Educational Colonoscopy Video Enhances Bowel Preparation Quality and Comprehension in an Inner City Population
Background:
The investigators assessed the use of a colonoscopy instructional video to improve both bowel preparation and education prior to procedure. Preceding studies have been vague, pinning patient education via diagrams and text as both pivotal and useless for compliance in bowel preparations. These studies however lacked assessment of comprehension prior to procedure.
Read more
Methodology:
This is a prospective study of diverse, inner city outpatient university center, first time colonoscopy patients given 1 of 2 on-site videos and written/verbal instruction. Experimentals saw a 5 min video on the purpose of colonoscopy, bowel preparation, pre-colonoscopy diet, and proper laxative use. Controls saw a 5 min video from the same spokesperson on upper endoscopy; which was trivial. Both groups were given a quiz within 30 days of the colonoscopy on demographics, and 14 test questions about colonoscopy and preparation. Subsequently, endoscopists used the additive Ottawa scale to rate quality of preparation (range 0-14) via: fluid (0=sm,1=mod, 2=lg) and cleanliness in each the right, mid and rectosigmoid colon, (0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate).
- Conditions
- Other Surgical Procedures
- Being tested
- Colonoscopy Educational Video, Placebo Educational Video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy Educational VideoOther
Brief Video utilization to assess comprehension and evaluation bowel preparation quality
Placebo Educational VideoOther
Brief Video utilization to provide placebo information and evaluation bowel preparation quality
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy educational Video | Experimental | Brief educational video of colonoscopy to determine comprehension and quality of bowel preparation. Receives: Other: Colonoscopy Educational Video |
| Control | Placebo comparator | Non-colonoscopy video as a control. Receives: Other: Placebo Educational Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome improvement in adequate bowel preparations
Bowel preparation quality indicator using Ottawa bowel prep scale.
Measured: in 30 days retention from the video
Comprehension of colonoscopy/colorectal cancer screening
Questionnaire
Measured: in 30 days retention from the video
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Other Surgical ProceduresStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906969
- Sponsor's protocol ID
- 1203000992
- Status last verified
- Sep 2016
- First submitted
- 13 Jun 2016
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
PubMed 12135020Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.
PubMed 21483463Pillai A, Menon R, Oustecky D, Ahmad A. Educational Colonoscopy Video Enhances Bowel Preparation Quality and Comprehension in an Inner City Population. J Clin Gastroenterol. 2018 Jul;52(6):515-518. doi: 10.1097/MCG.0000000000000893.
PubMed 28742732
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Colonoscopy Video Enhances Bowel Preparation Quality and Comprehension in an Inner City Population
- ClinicalTrials.gov ID
- NCT02906969
- Acronym / sponsor ID
- 1203000992
- Conditions
- Other Surgical Procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 20 Sep 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.
Background:
The investigators assessed the use of a colonoscopy instructional video to improve both bowel preparation and education prior to procedure. Preceding studies have been vague, pinning patient education via diagrams and text as both pivotal and useless for compliance in bowel preparations. These studies however lacked assessment of comprehension prior to procedure.
Methodology:
This is a prospective study of diverse, inner city outpatient university center, first time colonoscopy patients given 1 of 2 on-site videos and written/verbal instruction. Experimentals saw a 5 min video on the purpose of colonoscopy, bowel preparation, pre-colonoscopy diet, and proper laxative use. Controls saw a 5 min video from the same spokesperson on upper endoscopy; which was trivial. Both groups were given a quiz within 30 days of the colonoscopy on demographics, and 14 test questions about colonoscopy and preparation. Subsequently, endoscopists used the additive Ottawa scale to rate quality of preparation (range 0-14) via: fluid (0=sm,1=mod, 2=lg) and cleanliness in each the right, mid and rectosigmoid colon, (0=excellent, 1=good, 2=fair, 3=poor, 4=inadequate).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy educational Video | Experimental | Other: Colonoscopy Educational VideoBrief educational video of colonoscopy to determine comprehension and quality of bowel preparation. |
| Control | Placebo comparator | Other: Placebo Educational VideoNon-colonoscopy video as a control. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-85
- undergoing initial outpatient colonoscopy
- willing to participate in and sign consent for this study
- Morning session of colonoscopy procedure
Key exclusion criteria (3 listed)
- Patients were excluded if they had dementia or
- cognitive impairment or
- if they did not have a pre-procedural office visit.
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 |
|---|---|---|
| Colonoscopy Educational VideoBrief Video utilization to assess comprehension and evaluation bowel preparation quality | Other | Colonoscopy educational Video |
| Placebo Educational VideoBrief Video utilization to provide placebo information and evaluation bowel preparation quality | Other | Control |
Primary outcome
Primary outcome improvement in adequate bowel preparations
Time frame: in 30 days retention from the video
Bowel preparation quality indicator using Ottawa bowel prep scale.
Comprehension of colonoscopy/colorectal cancer screening
Time frame: in 30 days retention from the video
Questionnaire
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 20 Sep 2016.
- Background: PubMed 12135020Rex DK, Imperiale TF, Latinovich DR, Bratcher LL. Impact of bowel preparation on efficiency and cost of colonoscopy. Am J Gastroenterol. 2002 Jul;97(7):1696-700. doi: 10.1111/j.1572-0241.2002.05827.x.
- Background: PubMed 21483463Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.
- Derived from this study: PubMed 28742732Pillai A, Menon R, Oustecky D, Ahmad A. Educational Colonoscopy Video Enhances Bowel Preparation Quality and Comprehension in an Inner City Population. J Clin Gastroenterol. 2018 Jul;52(6):515-518. doi: 10.1097/MCG.0000000000000893.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy Educational Video in people with Other Surgical Procedures, run by Drexel University.
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 4 inclusion and 3 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 20 Sep 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. Some participants in this study may receive a placebo. 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?
Primary outcome improvement in adequate bowel preparations (time frame: in 30 days retention from the video). 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?
On the ClinicalTrials.gov record for NCT02906969, which also lists 3 linked publications.
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 20 Sep 2016.