ColonoscopyNCT00308568
RCT of Mailed Brochure to Boost Adherence to Screening Colonoscopy
A study testing Mailed educational brochure in people with Colonoscopy and Mass Screening, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Colonoscopy, Mass Screening
- What is being tested?
- Mailed educational brochure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 628 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Referrals for screening colonoscopy; Asymptomatic; age>=50
Who cannot join
- Referrals for diagnostic colonoscopy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver and Health Sciences Center
Denver, Colorado, 80262
About this study
Official title: Randomized Controlled Trial of a Mailed Brochure to Increase Adherence to Referrals for Screening Colonoscopy
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.
- Conditions
- Colonoscopy, Mass Screening
- Being tested
- Mailed educational brochure
- Keywords
- screening colonoscopy, adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed educational brochureBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adherence to screening colonoscopy referral within at least three months of receipt of referral.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 628 participants
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- The Henry J. Kaiser Family Foundation
- Responsible party
- Sponsor
- Investigators
- Thomas D. Denberg, MD, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308568
- Sponsor's protocol ID
- 05-0038
- Other IDs
- MRSG-06-081-01-CPPB-01
- Status last verified
- May 2017
- First submitted
- 27 Mar 2006
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only through publication in journals, this is not an applicable clinical trial
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Mailed Brochure to Increase Adherence to Referrals for Screening Colonoscopy
- ClinicalTrials.gov ID
- NCT00308568
- Acronym / sponsor ID
- 05-0038
- Conditions
- Colonoscopy, Mass Screening
- Keywords
- screening colonoscopy, adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 628 participants
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- The Henry J. Kaiser Family Foundation
- Study start
- Feb 2006
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 29 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Referrals for screening colonoscopy; Asymptomatic; age>=50
Key exclusion criteria (1 listed)
- Referrals for diagnostic colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mailed educational brochure | Behavioural | – |
Primary outcome
Rate of adherence to screening colonoscopy referral within at least three months of receipt of referral.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: No. only through publication in journals, this is not an applicable clinical trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas D. Denberg, MD, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mailed educational brochure in people with Colonoscopy and Mass Screening, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of adherence to screening colonoscopy referral within at least three months of receipt of referral.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.