RCT of Mailed Brochure to Boost Adherence to Screening Co... | NCT00308568

Studies
RCT of Mailed Brochure to Boost Adherence to Screening Colonoscopy

NCT00308568

Sponsor

University of Colorado, Denver

Status

Completed

Last Update Posted

May 4, 2017Actual

Enrollment

628

Phase

Not Applicable

Conditions

Colonoscopy
Mass Screening

Interventions

Mailed educational brochure

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MRSG-06-081-01-CPPB-01	Other Identifier

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Mar 2006Actual

Completion Date

Mar 2006Actual

First Submitted Date

Mar 27, 2006

First Submission Date that Met QC Criteria

Mar 27, 2006

First Posted Date

Mar 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2017

Last Update Posted Date

May 4, 2017Actual

Name	Class
The Henry J. Kaiser Family Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the effect of a mailed educational brochure on adherence to referral for screening colonoscopy. The comparison (or control) group receives no mailer, which is usual care.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

628

Name	Type	Description	Arm Group Labels	Other Names
Mailed educational brochure	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of adherence to screening colonoscopy referral within at least three months of receipt of referral.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Referrals for screening colonoscopy; Asymptomatic; age>=50

Exclusion Criteria:

Referrals for diagnostic colonoscopy

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas D. Denberg, MD, PhD	University of Colorado, Denver	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Colorado at Denver and Health Sciences Center		Denver	Colorado	80262	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

only through publication in journals, this is not an applicable clinical trial

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided