Improving care for patients with inflammatory bowel disease using text messaging
Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management (PROMOTE IBD)
This study is testing if regular text messaging with healthcare providers can help people with inflammatory bowel disease manage their symptoms better and feel more in control of their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 13 Years and up |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 8 sites (San Diego, California and 7 other locations) |
| Trial ID | NCT06424769 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine if patients with inflammatory bowel disease (IBD) can achieve better health outcomes and feel more empowered in managing their condition through text messaging with their healthcare team and regular symptom monitoring via text-based surveys. Participants will be divided into two groups: one receiving enhanced text-based monitoring and communication, and the other receiving only educational content via text. Over a 12-month period, all participants will complete online surveys about their IBD and social risk factors, while some will also engage in additional symptom monitoring and direct communication with their medical team. The study will also explore how social and non-medical factors influence IBD symptoms and quality of life.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 13 and older with a diagnosis of Crohn's disease or ulcerative colitis who have access to a mobile phone and can engage with text messaging.
Not a fit: Patients who have undergone surgery resulting in a pouch or ostomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved disease management and quality of life for patients with inflammatory bowel disease.
How similar studies have performed: Previous studies have shown promise in using digital health interventions for chronic disease management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 13+ years old with IBD (Crohn's disease, ulcerative colitis, indeterminant colitis). * Followed at a participating site with an office visit (in-person or virtual) within the preceding 12 months. * Have access to a mobile phone and willing and able to receive and respond to text messages. * Willing to answer questions on electronic surveys. * Have the ability to read text messages and answer surveys in English or Spanish. Exclusion Criteria: * IBD patients s/p surgery with a current pouch or ostomy. * Unable to provide informed consent and child assent for minors.
Where this trial is running
San Diego, California and 7 other locations
- University of California San Diego — San Diego, California, United States (Recruiting)
- University of California San Francisco Benioff Children's Hospital — San Francisco, California, United States (Recruiting)
- Morehouse School of Medicine — Atlanta, Georgia, United States (Recruiting)
- Boston Medical Center — Boston, Massachusetts, United States (Recruiting)
- NYU Langone Health Lake Success — Lake Success, New York, United States (Recruiting)
- UNC-Chapel Hill School of Medicine — Chapel Hill, North Carolina, United States (Recruiting)
- Atrium Health Levine Children's — Charlotte, North Carolina, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Michael D Kappelman, MD, MPH — University of North Carolina, Chapel Hill
- Study coordinator: Michael D Kappelman, MD, MPH
- Email: michael_kappelman@med.unc.edu
- Phone: 919-962-9900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.