NCT02791854

Brief Summary

Innovative programs exist that suggest that care for people with chronic conditions is optimized when patients and providers have the information they need at the point of care and over time, to engage in shared planning and execution of treatment goals and care plans. This project aims to build an Inflammatory Bowel Disease Learning Health System, a shared information environment, that highlights collaboration among patients, clinicians and care team members, and researchers; for effective use of data for guiding care, value, improvement, and research.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Feb 2016

Longer than P75 for all trials

Geographic Reach
1 country

29 active sites

Status
enrolling by invitation

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 Progress69%
Feb 2016Dec 2030

Study Start

First participant enrolled

February 26, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
14.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

August 21, 2025

Status Verified

August 1, 2025

Enrollment Period

14.8 years

First QC Date

May 13, 2016

Last Update Submit

August 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of patients enrolled

    count of number of patients consented

    annually, up to 5 years

Secondary Outcomes (6)

  • Proportion of patients in remission

    annually, up to 5 years

  • Proportion of patients on steroids

    annually, up to 5 years

  • Proportion of patients admitted into the Emergency Room

    annually, up to 5 years

  • Proportion of patients hospitalized

    annually, up to 5 years

  • Proportion of patients with anemia

    annually, up to 5 years

  • +1 more secondary outcomes

Study Arms (1)

Registry participant

This is a registry study, the same information is collected from all participants.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

In order to participate in IBD Qorus, individuals must meet the following criteria: * 18 years of age or older * Diagnosis of Crohn's disease or ulcerative colitis or IBD unclassified * Accept the terms and conditions of Informed Consent and Authorization * Affiliated with a participating IBD Qorus site

You may qualify if:

  • years of age or older
  • Diagnosis of Crohn's disease or ulcerative colitis or IBD unclassified
  • Accept the terms and conditions of Informed Consent and Authorization
  • Affiliated with a participating IBD Qorus site

You may not qualify if:

  • Inability to provide informed consent
  • Study key personnel cannot enroll as a study participant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Cedars-Sinai Inflammatory Bowel Disease Center

Los Angeles, California, 90048, United States

Location

Hoag Digestive Health

Newport Beach, California, 92658, United States

Location

UC San Diego Health Inflammatory Bowel Disease Center

San Diego, California, 92037, United States

Location

University of Colorado Health

Denver, Colorado, 80045, United States

Location

Yale School of Medicine IBD Program

New Haven, Connecticut, 06520, United States

Location

MedStar Georgetown University Hospital Center for Inflammatory Bowel Disease

Washington D.C., District of Columbia, 20007, United States

Location

Gastro Health LLC

Miami, Florida, 33133, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Digestive Health Center

Boise, Idaho, 83704, United States

Location

University of Chicago Medicine Inflammatory Bowel Disease Center

Chicago, Illinois, 60637, United States

Location

Digestive Care Center

Evansville, Indiana, 47714, United States

Location

GastroIntestinal Specialists, A.M.C.

Shreveport, Louisiana, 71115, United States

Location

Corewell Health

Grand Rapids, Michigan, 49546, United States

Location

Dartmouth-Hitchcock Inflammatory Bowel Disease Center

Lebanon, New Hampshire, 03756, United States

Location

Saratoga Schenectady Gastroenterology Associates

Burnt Hills, New York, 12027, United States

Location

NYU Long Island- Inflammatory Bowel Disease Center

Mineola, New York, 11501, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

The Oregon Clinic - Gastroenterology

Portland, Oregon, 97220, United States

Location

Penn State Hershey Inflammatory Bowel Disease Center

Hershey, Pennsylvania, 17033, United States

Location

Regional GI

Lancaster, Pennsylvania, 17601, United States

Location

Gastroenterology Associates

Providence, Rhode Island, 02904, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine IBD Center

Houston, Texas, 77030, United States

Location

University of Utah Health Care

Salt Lake City, Utah, 84132, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Corey Siegel, MD, MS

    Dartmouth-Hitchcock Medical Center

    PRINCIPAL INVESTIGATOR
  • Gil Melmed, MD, MS

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Section Chief, Section of Gastroenterology

Study Record Dates

First Submitted

May 13, 2016

First Posted

June 7, 2016

Study Start

February 26, 2016

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

August 21, 2025

Record last verified: 2025-08

Locations