Bowel PreparationPhase 3NCT01099553
Improving Bowel Preparation With an Educational Video
A Phase 3 study testing Educational video and Written instructions in people with Bowel Preparation, run by Boston Medical Center at 1 site in United States.
Trial summary
The investigators goal is to improve bowel preparations with an educational video on the Center for Digestive Disorders (CDD) website that explains the steps required for bowel preparation for those patients undergoing screening colonoscopies. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Educational video and Written instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 2011
- Phase
- Phase 3
- 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
- all outpatients
- age >18
- referred and scheduled for an elective screening colonoscopy
Who cannot join
- inpatients
- prisoners
- patients allergic to PEG-ELS based laxatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Bowel Preparation With an Education Video
The investigators goal is to improve bowel preparations with an educational video on the Center for Digestive Disorders (CDD) website that explains the steps required for bowel preparation for those patients undergoing screening colonoscopies. The video will focus on explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the pre-colonoscopy diet, and the instructions for completing the laxative. In a randomized fashion, patients in the control group will receive the standard written bowel preparation instructions, while patients in the intervention group will receive standard written instructions plus a link to watch the instructional video. The investigators hypothesize that an educational tool that provides visual examples of a good and poor preparation, examples of the pre-colonoscopy diet, and an explanation of how to administer the laxative will lead to improved patient compliance and a better bowel preparation. In addition, the investigators hypothesize that a better quality bowel preparation will improve detection of colonic polyps and fewer recommendations for repeat colonoscopy based solely on inadequate bowel preparation.
- Conditions
- Bowel Preparation
- Being tested
- Educational video, Written instructions
- Keywords
- Educational video, colonoscopy, bowel preparation, Bowel preparation for colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoOther
Instructions to view an educational video about preparing for a colonoscopy
Written instructionsOther
Written instructions on preparing for a colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Standard preparation instructions | Other | The control arm will receive written instructions on preparing for a colonoscopy per standard of care at Boston Medical Center Receives: Other: Written instructions |
| Interventional | Experimental | The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus instructions asking them to watch an educational video on the Center for Digestive Disorders website 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
The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale
Measured: Day of colonoscopy only
Secondary outcomes (6)
Histology of polyp
number of adenomatous polyps
Measured: one week after colonoscopy
Colonoscope insertion and withdrawal times
time from insertion to cecum and time from cecum to anus
Measured: Day of colonoscopy only
Patient compliance
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
Measured: Day of colonoscopy only
Preparation associated side effects
Presence and severity of preparation associated side effects including: blaoting, abdominal pain, and nausea/vomiting
Measured: Day of colonoscopy only
Patient satisfaction
patient's perception of the helpfulness of the video as self-reported on a pre-procedure questionnaire.
Measured: Day of colonoscopy only
Number of repeat colonoscopies due to inadequate bowel preparation
Blinded endoscopist's assesment about the need for a repeat colonoscopy due to inadequate bowel preparation
Measured: Day of colonoscopy only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Jacobson, Boston Medical Center
- Investigators
- Brian C Jacobson, MD, MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01099553
- Sponsor's protocol ID
- H-29152
- Status last verified
- Aug 2012
- First submitted
- 2 Apr 2010
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Bowel Preparation With an Education Video
- ClinicalTrials.gov ID
- NCT01099553
- Acronym / sponsor ID
- H-29152
- Conditions
- Bowel Preparation
- Keywords
- Educational video, colonoscopy, bowel preparation, Bowel preparation for colonoscopy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Apr 2010 (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 goal is to improve bowel preparations with an educational video on the Center for Digestive Disorders (CDD) website that explains the steps required for bowel preparation for those patients undergoing screening colonoscopies. The video will focus on explaining the purpose of a screening colonoscopy, the rationale for bowel preparation, the pre-colonoscopy diet, and the instructions for completing the laxative. In a randomized fashion, patients in the control group will receive the standard written bowel preparation instructions, while patients in the intervention group will receive standard written instructions plus a link to watch the instructional video. The investigators hypothesize that an educational tool that provides visual examples of a good and poor preparation, examples of the pre-colonoscopy diet, and an explanation of how to administer the laxative will lead to improved patient compliance and a better bowel preparation. In addition, the investigators hypothesize that a better quality bowel preparation will improve detection of colonic polyps and fewer recommendations for repeat colonoscopy based solely on inadequate bowel preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard preparation instructions | Other | Other: Written instructionsThe control arm will receive written instructions on preparing for a colonoscopy per standard of care at Boston Medical Center |
| Interventional | Experimental | Other: Educational videoThe investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus instructions asking them to watch an educational video on the Center for Digestive Disorders website |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all outpatients
- age >18
- referred and scheduled for an elective screening colonoscopy
Key exclusion criteria (3 listed)
- inpatients
- prisoners
- patients allergic to PEG-ELS based laxatives
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 videoInstructions to view an educational video about preparing for a colonoscopy | Other | Interventional |
| Written instructionsWritten instructions on preparing for a colonoscopy | Other | Standard preparation instructions |
Primary outcome
Quality of bowel preparation
Time frame: Day of colonoscopy only
The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale
6 secondary outcomes
Histology of polyp
Time frame: one week after colonoscopy
Colonoscope insertion and withdrawal times
Time frame: Day of colonoscopy only
Patient compliance
Time frame: Day of colonoscopy only
Preparation associated side effects
Time frame: Day of colonoscopy only
Patient satisfaction
Time frame: Day of colonoscopy only
Number of repeat colonoscopies due to inadequate bowel preparation
Time frame: Day of colonoscopy only
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 31 Aug 2012.
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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.
Brian C Jacobson, MD, MPH principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Educational video and Written instructions in people with Bowel Preparation, run by Boston Medical Center 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 3 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 31 Aug 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of bowel preparation (time frame: Day of colonoscopy only). 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 31 Aug 2012.