UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007888 |
|---|---|
| Receipt number | R000009288 |
| Scientific Title | Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy |
| Date of disclosure of the study information | 2012/05/03 |
| Last modified on | 2012/11/19 22:18:17 |
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Basic information
Public title
Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy
Acronym
Impact of patient education with cartoon visual aids on the quality of bowel
preparation for colonoscopy
Scientific Title
Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy
Scientific Title:Acronym
Impact of patient education with cartoon visual aids on the quality of bowel
preparation for colonoscopy
Region
| Asia(except Japan) |
Condition
Condition
screening colonoscopy in health examination center
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of patient education using cartoon visual aids on the quality of bowel
preparation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was the quality of bowel preparation, assessed
using the Boston Bowel Preparation Scale (BBPS).
Key secondary outcomes
Secondary endpoints were the quality of bowel preparation assessed using the Universal Preparation Assessment Scale (UPAS); insertion, withdrawal,and work-up times; and polyp detection rates in the two groups. Logistic regression analysis was performed to determine the factors associated with poor bowel preparation according to BBPS < 5.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
conventional explanation
Interventions/Control_2
visual aids using cartoon
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing a screening
colonoscopy in a health examination center
Key exclusion criteria
Patients with colon diseases (inflammatory bowel disease, colorectal malignancy, or infectious colitis) that required treatment, a history of previous abdominopelvic surgery, a family history of colorectal neoplasia, and/or intestinal symptoms (constipation and/or diarrhea) were excluded.
Target sample size
202
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Su Jin Hong |
Organization
Soonchunhyang University College of Medicine
Division name
Internal medicine
Zip code
Address
Digestive Disease Center,Soonchunhyang University Bucheon Hospital,1174 Jung-Dong, Wonmi-Ku, Bucheon, Gyeonggi-do, 420-767, Korea
TEL
82-32-621-5087
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Soonchunhyang University College of Medicine
Division name
Internal medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Soonchunhyang University College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Soonchunhyang University College of Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 05 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 03 | Day |
Last modified on
| 2012 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009288
