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Improving Bowel Preparation for Colonoscopy With a Simple Educational Card

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brian Jacobson, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00643682
First received: March 20, 2008
Last updated: August 29, 2012
Last verified: August 2012
History of Changes
Results First Received: July 9, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Colonic Polyps
Colonic Neoplasms
Intervention: Other: Educational card

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Educational Card Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
Control Patients in this arm will be given the standard pre-endoscopy instructions.

Participant Flow:   Overall Study
    Educational Card     Control  
STARTED     999     1001  
COMPLETED     477     492  
NOT COMPLETED     522     509  
did not keep appointment                 522                 509  



  Baseline Characteristics
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Reporting Groups
  Description
Educational Card Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.
Control Patients in this arm will be given the standard pre-endoscopy instructions.
Total Total of all reporting groups

Baseline Measures
    Educational Card     Control     Total  
Number of Participants  
[units: participants]
 		  477     492     969  
Age  
[units: years]
Mean ± Standard Deviation 		  57  ± 8     57  ± 7     57  ± 8  
Gender  
[units: participants]
 		     
Female     279     287     566  
Male     198     205     403  
Region of Enrollment  
[units: participants]
 		     
United States     477     492     969  



  Outcome Measures
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1.  Primary:   Boston Bowel Preparation Scale Score   [ Time Frame: 2 years ]
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2.  Secondary:   Time to Advance Colonoscope From Anus to Tip of Cecum.   [ Time Frame: 2 years ]
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3.  Secondary:   Time to Withdraw Colonoscope From Tip of Cecum to Anus.   [ Time Frame: 2 years ]
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4.  Secondary:   Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.   [ Time Frame: 2 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Brian Jacobson, MD, Principal Investigator
Organization: Boston Medical Center
phone: 6176386563
e-mail: brian.jacobson@bmc.org


No publications provided by Boston Medical Center

Publications automatically indexed to this study:


Responsible Party: Brian Jacobson, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00643682     History of Changes
Other Study ID Numbers: BMC-GI-1
Study First Received: March 20, 2008
Results First Received: July 9, 2012
Last Updated: August 29, 2012
Health Authority: United States: Institutional Review Board