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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007888
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Soonchunhyang University College of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009288

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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