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

NCT06424769 | Enrolling By Invitation

• 2 other identifiers: 24-0699855107
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Colitis

Keywords

Text Messaging; Symptom Monitoring; Social Risk Factors

Outcome Measures

Primary Outcomes (1)

• Change in Patient Activation using PAM

  The primary outcome is the change in patient activation from baseline, with a 4-point improvement on Patient Activation Measure (PAM) scale considered a minimal clinically important difference (MCID). Patient activation is an assessment of the knowledge, skills and confidence of patients to manage their health. In chronic diseases, activated patients are more likely to adhere to treatment, perform regular self-monitoring at home and obtain regular chronic care. Activated patients are also more likely to make healthier lifestyle choices and preventative behaviors. Longitudinal improvement in patient activation measures is associated with improved clinical outcomes, decreased unplanned healthcare utilization and lower costs.

  Baseline, 12 months

Secondary Outcomes (3)

• Remission at 52 Weeks

  12 months

• IBD-Related Quality of Life

  up to 12 months

• Unplanned Healthcare Utilization

  up to 12 months

Study Arms (2)

Enhanced Digital Care Arm

ACTIVE COMPARATOR

Participants will receive brief check-in surveys about their IBD symptoms minimally once a month, via text messaging. Participants will also receive IBD educational text messages twice each week.

Other: Enhanced Digital Care; Other: Education

Specialized Education Arm

PLACEBO COMPARATOR

Participants in this arm will receive IBD educational text messages twice each week.

Other: Education

Interventions

Enhanced Digital Care OTHER

Participants will receive brief check-in surveys about their IBD symptoms once a month, via text messaging. If the survey response indicates significant symptoms, an alert will be sent to the participant's IBD care team and participant will receive more frequent surveys (weekly) over the next month. Participants and their IBD clinical team will be able to communicate by text for non-emergency IBD-related questions.

Enhanced Digital Care Arm

Education OTHER

Participants will receive education texts about IBD from trusted sources approximately twice a week. Topics will include: diet, medication adherence, fatigue, preventative care and other relevant issues.

Enhanced Digital Care Arm; Specialized Education Arm

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• IBD patients s/p surgery with a current pouch or ostomy.
• Unable to provide informed consent and child assent for minors.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• University of Pennsylvania: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (8)

University of California San Diego

San Diego, California, 92093, United States

Location

University of California San Francisco Benioff Children's Hospital

San Francisco, California, 94158, United States

Location

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

NYU Langone Health Lake Success

Lake Success, New York, 11042, United States

Location

UNC-Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Atrium Health Levine Children's

Charlotte, North Carolina, 28203, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (11)

• Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged >/=18 Years - United States, 2015. MMWR Morb Mortal Wkly Rep. 2016 Oct 28;65(42):1166-1169. doi: 10.15585/mmwr.mm6542a3.

  PMID: 27787492 BACKGROUND

• Singh S, Qian AS, Nguyen NH, Ho SKM, Luo J, Jairath V, Sandborn WJ, Ma C. Trends in U.S. Health Care Spending on Inflammatory Bowel Diseases, 1996-2016. Inflamm Bowel Dis. 2022 Mar 2;28(3):364-372. doi: 10.1093/ibd/izab074.

  PMID: 33988697 BACKGROUND

• Baumgart DC, Le Berre C. Newer Biologic and Small-Molecule Therapies for Inflammatory Bowel Disease. N Engl J Med. 2021 Sep 30;385(14):1302-1315. doi: 10.1056/NEJMra1907607. No abstract available.

  PMID: 34587387 BACKGROUND

• Liu JJ, Abraham BP, Adamson P, Barnes EL, Brister KA, Damas OM, Glover SC, Hooks K, Ingram A, Kaplan GG, Loftus EV, McGovern DPB, Narain-Blackwell M, Odufalu FD, Quezada S, Reeves V, Shen B, Stappenbeck TS, Ward L. The Current State of Care for Black and Hispanic Inflammatory Bowel Disease Patients. Inflamm Bowel Dis. 2023 Feb 1;29(2):297-307. doi: 10.1093/ibd/izac124.

  PMID: 35816130 BACKGROUND

• Afzali A, Cross RK. Racial and Ethnic Minorities with Inflammatory Bowel Disease in the United States: A Systematic Review of Disease Characteristics and Differences. Inflamm Bowel Dis. 2016 Aug;22(8):2023-40. doi: 10.1097/MIB.0000000000000835.

  PMID: 27379446 BACKGROUND

• Barnes EL, Loftus EV Jr, Kappelman MD. Effects of Race and Ethnicity on Diagnosis and Management of Inflammatory Bowel Diseases. Gastroenterology. 2021 Feb;160(3):677-689. doi: 10.1053/j.gastro.2020.08.064. Epub 2020 Oct 21.

  PMID: 33098884 BACKGROUND

• Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. doi: 10.1111/j.1475-6773.2004.00269.x.

  PMID: 15230939 BACKGROUND

• Hibbard JH, Greene J. What the evidence shows about patient activation: better health outcomes and care experiences; fewer data on costs. Health Aff (Millwood). 2013 Feb;32(2):207-14. doi: 10.1377/hlthaff.2012.1061.

  PMID: 23381511 BACKGROUND

• Anderson G, Rega ML, Casasanta D, Graffigna G, Damiani G, Barello S. The association between patient activation and healthcare resources utilization: a systematic review and meta-analysis. Public Health. 2022 Sep;210:134-141. doi: 10.1016/j.puhe.2022.06.021. Epub 2022 Aug 12.

  PMID: 35970015 BACKGROUND

• Barnes EL, Long MD, Kappelman MD, Martin CF, Sandler RS. High Patient Activation Is Associated With Remission in Patients With Inflammatory Bowel Disease. Inflamm Bowel Dis. 2019 Jun 18;25(7):1248-1254. doi: 10.1093/ibd/izy378.

  PMID: 30590700 BACKGROUND

• Haj O, Lipkin M, Kopylov U, Sigalit S, Magnezi R. Patient activation and its association with health indices among patients with inflammatory bowel disease. Therap Adv Gastroenterol. 2022 Oct 6;15:17562848221128757. doi: 10.1177/17562848221128757. eCollection 2022.

  PMID: 36225610 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Colitis

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Michael D Kappelman, MD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After completing their baseline survey, consented participants will be randomized to usual care and intervention groups in a 2:1 allocation ratio. A computer-generated, centralized randomization with permuted block randomization within sites to ensure allocation concealment will be utilized.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 22, 2024
• Study Start: July 24, 2024
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: From 9 months after the end of the trial and publication of study results to up to 36 months.
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (8)