RECRUITING

Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn whether IBD patients have better disease outcomes and feel more empowered to manage their condition if they have access to text messaging with their clinical team and if their symptoms are more regularly monitored through text-based surveys. Researchers will compare participants who have access to text-based monitoring, communication and education to participants who have access to text-based education alone. Researchers will also examine if different social and other non-medical factors impact IBD symptoms and quality of life. All participants will: * complete 5 brief on-line surveys over 12 months about their IBD and social risk factors, * receive IBD education content by text message up to 2 times a week. Some participants will also: * receive additional surveys by text to monitor their IBD progression, * have the opportunity to directly text message their IBD medical team.

Official Title

Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management (PROMOTE IBD)

Quick Facts

Study Start:2024-07-24
Study Completion:2028-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06424769

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:13 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 13+ years old with IBD (Crohn's disease, ulcerative colitis, indeterminant colitis).
  2. * Followed at a participating site with an office visit (in-person or virtual) within the preceding 12 months.
  3. * Have access to a mobile phone and willing and able to receive and respond to text messages.
  4. * Willing to answer questions on electronic surveys.
  5. * Have the ability to read text messages and answer surveys in English or Spanish.
  1. * IBD patients s/p surgery with a current pouch or ostomy.
  2. * Unable to provide informed consent and child assent for minors.

Contacts and Locations

Study Contact

Michael D Kappelman, MD, MPH
CONTACT
919-962-9900
michael_kappelman@med.unc.edu
Margie E Boccieri, MA
CONTACT
919-962-9900
margie_boccieri@med.unc.edu

Principal Investigator

Michael D Kappelman, MD, MPH
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

University of California San Diego
San Diego, California, 92093
United States
University of California San Francisco Benioff Children's Hospital
San Francisco, California, 94158
United States
Morehouse School of Medicine
Atlanta, Georgia, 30310
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
NYU Langone Health Lake Success
Lake Success, New York, 11042
United States
UNC-Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599
United States
Atrium Health Levine Children's
Charlotte, North Carolina, 28203
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Michael D Kappelman, MD, MPH, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-24
Study Completion Date2028-09

Study Record Updates

Study Start Date2024-07-24
Study Completion Date2028-09

Terms related to this study

Keywords Provided by Researchers

  • Text Messaging
  • Symptom Monitoring
  • Social Risk Factors

Additional Relevant MeSH Terms

  • Inflammatory Bowel Diseases
  • Crohn Disease
  • Ulcerative Colitis
  • Colitis