NCT00643682

Brief Summary

The purpose of this study is to determine whether adding a simple educational card to standard pre-procedure instructions improves the quality of bowel preparation for colonoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3 years until next milestone

Results Posted

Study results publicly available

October 1, 2012

Completed
Last Updated

October 1, 2012

Status Verified

August 1, 2012

Enrollment Period

2.3 years

First QC Date

March 20, 2008

Results QC Date

July 9, 2012

Last Update Submit

August 29, 2012

Conditions

Colonic PolypsColonic Neoplasms

Keywords

colonoscopybowel preparationpatient educationpolyp detection

Outcome Measures

Primary Outcomes (1)

  • Boston Bowel Preparation Scale Score

    An ordinal scale. 0=fully unprepared colon and 9=perfectly clean colon. Higher values represent a better outcome. For reference please see: Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC. The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointestinal Endoscopy 2009;69:620-625. PMCID: PMC2763922

    2 years

Secondary Outcomes (3)

  • Time to Advance Colonoscope From Anus to Tip of Cecum.

    2 years

  • Time to Withdraw Colonoscope From Tip of Cecum to Anus.

    2 years

  • Number of Repeat Procedures Recommended Due to Inadequate Bowel Preparation.

    2 years

Study Arms (2)

A

EXPERIMENTAL

Patients in this arm will be given an educational card in addition to the standard pre-endoscopy instructions.

Other: Educational card

B

NO INTERVENTION

Patients in this arm will be given the standard pre-endoscopy instructions.

Interventions

Educational cardOTHER

A 4x6 inch educational card containing a photo of an unprepared colon and a clean colon with the caption: "Drinking all the bowel cleaning medicine as described in the enclosed instructions lets the doctor see your colon better during your colonoscopy."

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Outpatients
  • years old or older
  • Referred and scheduled for an elective screening colonoscopy

You may not qualify if:

  • Inpatients
  • Prisoners
  • Cognitively impaired patients
  • Legally blind patients
  • Patients allergic to polyethylene glycol electrolyte lavage solution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • Calderwood AH, Lai EJ, Fix OK, Jacobson BC. An endoscopist-blinded, randomized, controlled trial of a simple visual aid to improve bowel preparation for screening colonoscopy. Gastrointest Endosc. 2011 Feb;73(2):307-14. doi: 10.1016/j.gie.2010.10.013. Epub 2010 Dec 18.

    PMID: 21168840DERIVED

MeSH Terms

Conditions

Colonic PolypsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Brian Jacobson, MD, Principal Investigator
Organization
Boston Medical Center
brian.jacobson@bmc.org
6176386563

Study Officials

  • Brian C Jacobson, MD, MPH

    Boston University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

February 1, 2006

Primary Completion

June 1, 2008

Study Completion

October 1, 2009

Last Updated

October 1, 2012

Results First Posted

October 1, 2012

Record last verified: 2012-08

Locations

US(1)