Ottawa Scale <6Phase 3NCT01911026
The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy
A Phase 3 study testing Reinforcement Nurse Education in people with Ottawa Scale <6, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial summary
Effective bowel preparation is important for examination of the entire colon adequately and for identifying colonic lesions during colonoscopy. However, it is well known that bowel preparation of inpatients is much poorer than that of outpatients. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ottawa Scale <6
- What is being tested?
- Reinforcement Nurse Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Jan 2014
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all inpatients
- age >18
- referred and scheduled for an elective screening colonoscopy
Who cannot join
- outpatients
- pregnancy
- breast feeding
- prior history of surgical large bowel resection
- patients allergic to PEG-ELS based laxatives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy; Randomized Single Blinded Study
Effective bowel preparation is important for examination of the entire colon adequately and for identifying colonic lesions during colonoscopy. However, it is well known that bowel preparation of inpatients is much poorer than that of outpatients. Our goal is to improve bowel preparations with reinforcement of nurse education that explains the steps required for bowel preparation for inpatients undergoing colonoscopies. The education 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. 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 explanation from reinforcement-educated nurse. The investigators hypothesize that patients received a explanation from reinforcement-educated nurses 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 patients' satisfaction for colonoscopy.
- Conditions
- Ottawa Scale <6
- Being tested
- Reinforcement Nurse Education
- Keywords
- Bowel preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinforcement Nurse EducationOther
The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus instructions from reinforcement educated nurse
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus interventional instructions from reinforcement educated nurse such as 'Reinforcement Nurse Education' Receives: Other: Reinforcement Nurse Education |
| Standard preparation instructions | No intervention | The control arm will receive written instructions on preparing for a colonoscopy per standard of care at Keimyung University Dongsan Medical Center |
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 Boston and Ottawa bowel preparation scale
Measured: day 1
Secondary outcomes (4)
Patient compliance
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
Measured: baseline
Colonoscope insertion and withdrawal times
Time from insertion to cecum and time from cecum to anus
Measured: day 1
Patient's willingness to do bowel preparation next time
Patient's willingness to do bowel preparation next time self-reported on a pre-procedure questionnaire
Measured: baseline
Preparation associated side effects
Presence and severity of preparation associated side effects including: bloating, abdominal pain, and nausea/vomiting
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ottawa Scale <6Studies 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
- Investigator
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Eun Soo, Keimyung University Dongsan Medical Center
- Investigators
- Eun Soo Kim, Professor, Principal investigator, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911026
- Sponsor's protocol ID
- 2013-05-049-001
- Status last verified
- Dec 2014
- First submitted
- 22 Jul 2013
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Nurse Education on the Quality of Inpatient Bowel Preparation for Colonoscopy; Randomized Single Blinded Study
- ClinicalTrials.gov ID
- NCT01911026
- Acronym / sponsor ID
- 2013-05-049-001
- Conditions
- Ottawa Scale <6
- Keywords
- Bowel preparation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Jul 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.
Effective bowel preparation is important for examination of the entire colon adequately and for identifying colonic lesions during colonoscopy. However, it is well known that bowel preparation of inpatients is much poorer than that of outpatients. Our goal is to improve bowel preparations with reinforcement of nurse education that explains the steps required for bowel preparation for inpatients undergoing colonoscopies. The education 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. 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 explanation from reinforcement-educated nurse. The investigators hypothesize that patients received a explanation from reinforcement-educated nurses 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 patients' satisfaction for colonoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: Reinforcement Nurse EducationThe investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus interventional instructions from reinforcement educated nurse such as 'Reinforcement Nurse Education' |
| Standard preparation instructions | No intervention | –The control arm will receive written instructions on preparing for a colonoscopy per standard of care at Keimyung University Dongsan Medical Center |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all inpatients
- age >18
- referred and scheduled for an elective screening colonoscopy
Key exclusion criteria (5 listed)
- outpatients
- pregnancy
- breast feeding
- prior history of surgical large bowel resection
- 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 |
|---|---|---|
| Reinforcement Nurse EducationThe investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus instructions from reinforcement educated nurse | Other | Interventional |
Primary outcome
Quality of bowel preparation
Time frame: day 1
The primary outcome will be the endoscopist's assessment of the quality of preparation using Boston and Ottawa bowel preparation scale
4 secondary outcomes
Patient compliance
Time frame: baseline
Colonoscope insertion and withdrawal times
Time frame: day 1
Patient's willingness to do bowel preparation next time
Time frame: baseline
Preparation associated side effects
Time frame: baseline
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 30 Dec 2014.
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.
Eun Soo Kim, Professor principal investigator
Keimyung University Dongsan 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 Reinforcement Nurse Education in people with Ottawa Scale <6, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
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 5 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 30 Dec 2014. 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 South Korea. 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 1). 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 30 Dec 2014.