NCT02464618

Brief 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 physician, or after scheduling by the gastrointestinal endoscopist. Improved adherence and better quality of procedures are postulated with involvement of social contacts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
812

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration 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

June 26, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2017

Completed
Last Updated

September 17, 2018

Status Verified

June 1, 2018

Enrollment Period

2.7 years

First QC Date

June 2, 2015

Last Update Submit

September 13, 2018

Conditions

Keywords

ColonoscopyUpper endoscopyAdherenceDisparities

Outcome Measures

Primary Outcomes (2)

  • 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

    6 months

  • Compliance with scheduled upper endoscopy and colonoscopy

    For specialty subjects: Completing scheduled upper endoscopy or colonoscopy

    Scheduled procedure time, an average of 8 weeks

Secondary Outcomes (1)

  • Bowel preparation quality

    At scheduled colonoscopy, an average of 8 weeks

Other Outcomes (1)

  • Social contact's activity

    During the duration of the project, an average of 6 months

Study Arms (2)

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

Behavioral: Social contact intervention

Interventions

The social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy

Social contact intervention

Eligibility Criteria

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

You may qualify if:

  • Patients referred for out-patient colonoscopy by primary care physicians
  • Patients scheduled for out-patient screening colonoscopy
  • Patients scheduled for out-patient upper endoscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

Related Publications (5)

  • 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.

    PMID: 25180285BACKGROUND
  • Tammana 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.

    PMID: 24574761BACKGROUND
  • Badurdeen 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.

    PMID: 22571991BACKGROUND
  • Laiyemo 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.

    PMID: 22183821BACKGROUND
  • Laiyemo 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.

MeSH Terms

Conditions

Patient ComplianceColonic Neoplasms

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Adeyinka O Laiyemo, MD, MPH

    Howard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 8, 2015

Study Start

June 26, 2014

Primary Completion

March 7, 2017

Study Completion

March 7, 2017

Last Updated

September 17, 2018

Record last verified: 2018-06

Locations