NCT00883545

Brief Summary

The purpose of this study is to determine whether women who are offered screening colonoscopy will be more likely to schedule and complete this procedure if they are given the option of a woman endoscopist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
625

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2008

Shorter than P25 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

October 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 7, 2013

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

April 15, 2009

Last Update Submit

January 3, 2013

Conditions

Colonoscopy

Keywords

Adherence to screening colonoscopy in women

Outcome Measures

Primary Outcomes (1)

  • Determine whether the option of a woman endoscopist is associated with increased woman patient willingness to schedule and complete screening colonoscopy.

    6 months

Secondary Outcomes (1)

  • Identify socio-demographic predictors of (a) completing a screening colonoscopy and (b) requesting a woman endoscopist (e.g. race/ethnicity, age, health insurance, marital status).

    6 months

Study Arms (2)

Woman endoscopist

EXPERIMENTAL
Other: Woman endoscopist

Usual care

ACTIVE COMPARATOR
Other: Usual care

Interventions

Woman endoscopistOTHER

This group will receive an invitation to schedule a screening colonoscopy with a woman endoscopist.

Woman endoscopist
Usual careOTHER

This group will receive an invitation to schedule a screening colonoscopy with any available endoscopist.

Usual care

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female gender
  • Age between 50 and 70
  • Receiving primary care at a University Medicine clinic

You may not qualify if:

  • No visit to a University Medicine clinic in 18 months or more
  • Deceased
  • Pregnant
  • Terminal or cancer diagnosis
  • No longer receiving primary care at a University Medicine clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Study Officials

  • Thomas D Denberg, MD, PhD

    University of Colorado Denver Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 17, 2009

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 7, 2013

Record last verified: 2012-09

Locations

US(1)