ComplianceNCT02464618
Using Patients' Social Contact to Improve Out-Patient Endoscopy Among Blacks
A study testing Social contact intervention in people with Compliance and Colon Cancer, run by Howard University at 1 site in United States.
Trial summary
Non-attendance to out-patient endoscopic procedures is high among underserved blacks. The overall goal of this proposal is to evaluate the effect of directly involving a social contact (chosen by the patient) on completion and quality of out-patient endoscopy recommended for the patient by his/her primary care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compliance, Colon Cancer
- What is being tested?
- Social contact intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2014to 7 Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for out-patient colonoscopy by primary care physicians
- Patients scheduled for out-patient screening colonoscopy
- Patients scheduled for out-patient upper endoscopy
Who cannot join
- Patients who were referred for colorectal cancer (CRC) screening as in-patients
- Patients with personal history of familial adenomatous polyposis syndrome (FAP)
- Patients with family history of Hereditary non-polyposis colorectal cancer syndrome (HNPCC)
- Patients with inflammatory bowel disease
- Patients with Crohn's disease
- Patients with ulcerative colitis
- Patients with personal history of CRC
- Patients who have had colonic resection
Trial locations and contacts
1 site in 1 country.
United States1 site
Howard University
Washington D.C., District of Columbia, 20060
About this study
Official title: Improving Attendance to Outpatient Endoscopy Among Blacks
Non-attendance to out-patient endoscopic procedures is high among underserved blacks. The overall goal of this proposal is to evaluate the effect of directly involving a social contact (chosen by the patient) on completion and quality of out-patient endoscopy recommended for the patient by his/her primary care physician, or after scheduling by the gastrointestinal endoscopist.
Improved adherence and better quality of procedures are postulated with involvement of social contacts.
Read the detailed description
The overarching goal of this proposal is to determine whether directly involving a social contact, chosen by the patient, will improve the completion and quality of scheduled out-patient endoscopy among blacks.
These are three sub-projects:
Project 1: Involves recruiting 400 patients referred for colonoscopy by their primary care physicians
Project 2: Involves recruiting 400 patients scheduled for colonoscopy by their endoscopist
Project 3: Involves recruiting 200 patients scheduled for upper endoscopy by their endoscopists
- Conditions
- Compliance, Colon Cancer
- Being tested
- Social contact intervention
- Keywords
- Colonoscopy, Upper endoscopy, Adherence, Disparities
- Medical subject headings
- Patient Compliance, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social contact interventionBehavioural
The social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | The social contact of patients in this arm will not be contacted |
| Social contact intervention | Active comparator | The social contact of patients in this arm will be contacted and asked to facilitate the endoscopy care plan of the patient Receives: Behavioral: Social contact intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with appointment and colonoscopy
For primary care subjects: Making appointment with Gastrointestinal endoscopist within 3 months and completing colonoscopy within 6 months of enrolment
Measured: 6 months
Compliance with scheduled upper endoscopy and colonoscopy
For specialty subjects: Completing scheduled upper endoscopy or colonoscopy
Measured: Scheduled procedure time, an average of 8 weeks
Secondary outcomes (1)
Bowel preparation quality
Adequacy of bowel preparation with ratings of good to excellent on Aronchick scale
Measured: At scheduled colonoscopy, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start26 Jun 2014
- Primary completion7 Mar 2017
- Study completion7 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ComplianceStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Howard University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adeyinka O Laiyemo, MD, MPH, Principal investigator, Howard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464618
- Sponsor's protocol ID
- IRB-14-MED-11
- Status last verified
- Jun 2018
- First submitted
- 2 Jun 2015
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Laiyemo AO, Williams CD, Burnside C, Moghadam S, Sanasi-Bhola KD, Kwagyan J, Brim H, Ashktorab H, Scott VF, Smoot DT. Factors associated with attendance to scheduled outpatient endoscopy. Postgrad Med J. 2014 Oct;90(1068):571-5. doi: 10.1136/postgradmedj-2012-131650. Epub 2014 Sep 1.
PubMed 25180285Tammana VS, Laiyemo AO. Colorectal cancer disparities: issues, controversies and solutions. World J Gastroenterol. 2014 Jan 28;20(4):869-76. doi: 10.3748/wjg.v20.i4.869.
PubMed 24574761Badurdeen DS, Umar NA, Begum R, Sanderson AK 2nd, Jack M, Mekasha G, Kwagyan J, Smoot DT, Laiyemo AO. Timing of procedure and compliance with outpatient endoscopy among an underserved population in an inner-city tertiary institution. Ann Epidemiol. 2012 Jul;22(7):531-5. doi: 10.1016/j.annepidem.2012.04.013. Epub 2012 May 8.
PubMed 22571991Laiyemo AO. In search of a perfect solution to ensure that "no colon is left behind". Dig Dis Sci. 2012 Feb;57(2):263-5. doi: 10.1007/s10620-011-2010-6. Epub 2011 Dec 20. No abstract available.
PubMed 22183821Laiyemo AO, Kwagyan J, Williams CD, Rogers J, Kibreab A, Jack MA, Lee EE, Brim H, Ashktorab H, Howell CD, Smoot DT, Platz EA. Using Patients' Social Network to Improve Compliance to Outpatient Screening Colonoscopy Appointments Among Blacks: A Randomized Clinical Trial. Am J Gastroenterol. 2019 Oct;114(10):1671-1677. doi: 10.14309/ajg.0000000000000387.
PubMed 31478919
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Attendance to Outpatient Endoscopy Among Blacks
- ClinicalTrials.gov ID
- NCT02464618
- Acronym / sponsor ID
- IRB-14-MED-11
- Conditions
- Compliance, Colon Cancer
- Keywords
- Colonoscopy, Upper endoscopy, Adherence, Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Howard UniversityUniversity, hospital or other
- Study start
- 26 Jun 2014 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 7 Mar 2017 (actual)
- First posted
- 8 Jun 2015 (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.
Non-attendance to out-patient endoscopic procedures is high among underserved blacks. The overall goal of this proposal is to evaluate the effect of directly involving a social contact (chosen by the patient) on completion and quality of out-patient endoscopy recommended for the patient by his/her primary care physician, or after scheduling by the gastrointestinal endoscopist.
Improved adherence and better quality of procedures are postulated with involvement of social contacts.
Detailed description
The overarching goal of this proposal is to determine whether directly involving a social contact, chosen by the patient, will improve the completion and quality of scheduled out-patient endoscopy among blacks.
These are three sub-projects:
Project 1: Involves recruiting 400 patients referred for colonoscopy by their primary care physicians
Project 2: Involves recruiting 400 patients scheduled for colonoscopy by their endoscopist
Project 3: Involves recruiting 200 patients scheduled for upper endoscopy by their endoscopists
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –The social contact of patients in this arm will not be contacted |
| Social contact intervention | Active comparator | Behavioral: Social contact interventionThe social contact of patients in this arm will be contacted and asked to facilitate the endoscopy care plan of the patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients referred for out-patient colonoscopy by primary care physicians
- Patients scheduled for out-patient screening colonoscopy
- Patients scheduled for out-patient upper endoscopy
Key exclusion criteria (8 listed)
- Patients who were referred for colorectal cancer (CRC) screening as in-patients
- Patients with personal history of familial adenomatous polyposis syndrome (FAP)
- Patients with family history of Hereditary non-polyposis colorectal cancer syndrome (HNPCC)
- Patients with inflammatory bowel disease
- Patients with Crohn's disease
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 |
|---|---|---|
| Social contact interventionThe social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy | Behavioural | Social contact intervention |
Primary outcome
Compliance with appointment and colonoscopy
Time frame: 6 months
For primary care subjects: Making appointment with Gastrointestinal endoscopist within 3 months and completing colonoscopy within 6 months of enrolment
Compliance with scheduled upper endoscopy and colonoscopy
Time frame: Scheduled procedure time, an average of 8 weeks
For specialty subjects: Completing scheduled upper endoscopy or colonoscopy
1 secondary outcome
Bowel preparation quality
Time frame: At scheduled colonoscopy, an average of 8 weeks
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 17 Sep 2018.
- Background: PubMed 25180285Laiyemo AO, Williams CD, Burnside C, Moghadam S, Sanasi-Bhola KD, Kwagyan J, Brim H, Ashktorab H, Scott VF, Smoot DT. Factors associated with attendance to scheduled outpatient endoscopy. Postgrad Med J. 2014 Oct;90(1068):571-5. doi: 10.1136/postgradmedj-2012-131650. Epub 2014 Sep 1.
- Background: PubMed 24574761Tammana VS, Laiyemo AO. Colorectal cancer disparities: issues, controversies and solutions. World J Gastroenterol. 2014 Jan 28;20(4):869-76. doi: 10.3748/wjg.v20.i4.869.
- Background: PubMed 22571991Badurdeen DS, Umar NA, Begum R, Sanderson AK 2nd, Jack M, Mekasha G, Kwagyan J, Smoot DT, Laiyemo AO. Timing of procedure and compliance with outpatient endoscopy among an underserved population in an inner-city tertiary institution. Ann Epidemiol. 2012 Jul;22(7):531-5. doi: 10.1016/j.annepidem.2012.04.013. Epub 2012 May 8.
- Background: PubMed 22183821Laiyemo AO. In search of a perfect solution to ensure that "no colon is left behind". Dig Dis Sci. 2012 Feb;57(2):263-5. doi: 10.1007/s10620-011-2010-6. Epub 2011 Dec 20. No abstract available.
- Derived from this study: PubMed 31478919Laiyemo AO, Kwagyan J, Williams CD, Rogers J, Kibreab A, Jack MA, Lee EE, Brim H, Ashktorab H, Howell CD, Smoot DT, Platz EA. Using Patients' Social Network to Improve Compliance to Outpatient Screening Colonoscopy Appointments Among Blacks: A Randomized Clinical Trial. Am J Gastroenterol. 2019 Oct;114(10):1671-1677. doi: 10.14309/ajg.0000000000000387.
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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.
Adeyinka O Laiyemo, MD, MPH principal investigator
Howard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social contact intervention in people with Compliance and Colon Cancer, run by Howard University 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 3 inclusion and 8 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 17 Sep 2018. 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?
Compliance with appointment and colonoscopy (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02464618, which also lists 5 linked publications.
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 17 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.