Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management
NCT ID: NCT06424769
Last Updated: 2025-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
900 participants
INTERVENTIONAL
2024-07-24
2028-09-30
Brief Summary
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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.
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Detailed Description
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The researchers are conducting a multi-center, open-label, randomized clinical trial to evaluate the effectiveness of a tailored digital health intervention versus usual care to improve disease management and patient activation among teenage and adult patients with IBD. The researchers hypothesize the intervention will lead to higher patient activation, improved outcomes and quality of life and reduced health disparities among children and adults with IBD. Within the usual care arm, researchers will measure Social Determinants of Health at enrollment and evaluate associations between these factors and time spent in remission over a 1-year follow-up period.
Participants in both arms will complete electronic surveys at baseline and then quarterly thereafter for 12-months. The baseline survey will include: 1) basic demographic information, 2) social risk assessment (adapted from the Health-related Social Needs Screening Tool by the Centers for Medicare \& Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) National Health Interview Survey (NHIS) survey, this measure will be completed by the parent/guardian for pediatric participants), 3) patient reported outcomes for ulcerative colitis and Crohn's disease (PRO-2-UC or PRO-2-CD), 4) IBD-related quality of life (Short Inflammatory Bowel Disease Questionnaire (SIBDQ)), 5) IBD-related healthcare utilization, 6) IBD-related medication adherence and 7) patient activation measure (PAM Survey). All of these except demographic questions will be repeated at 12 months. Quarterly surveys at 3, 6, and 9 months will only include questions on IBD patient-reported outcomes and unplanned healthcare utilization (\~8 questions) with the addition of medication adherence questions and the PAM at 6-months (12 additional questions).
In addition to these patient-reported data, providers and research coordinator at each site will perform chart abstraction to identify specific clinical disease-level factors (including disease severity and phenotype) and treatment-level factors (prior and current therapies).
Participants in both arms will receive texts approximately twice a week containing curated educational content. All participants will receive usual clinical care per discretion of their treating provider and will maintain usual healthcare interactions with the clinical team using their preferred method of interaction including phone or electronic communications within their Electronic Health Record (EHR).
Participants assigned to the intervention arm will receive enhanced electronic health care delivered through text messaging. This includes short monthly check in surveys to assess IBD disease progression. Survey cadence will increase to weekly for 4 weeks at a time if a participant reports severe symptoms. This also includes the opportunity to communicate with their clinical team through text messaging.
Among participants assigned to the usual care arm of the pragmatic trial, a cohort analysis will evaluate associations between social risk and IBD natural history and outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Enhanced Digital Care Arm
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.
Enhanced Digital Care
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.
Education
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.
Specialized Education Arm
Participants in this arm will receive IBD educational text messages twice each week.
Education
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.
Interventions
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Enhanced Digital Care
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.
Education
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Unable to provide informed consent and child assent for minors.
13 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Centers for Disease Control and Prevention
FED
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Michael D Kappelman, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
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University of California San Diego
San Diego, California, United States
University of California San Francisco Benioff Children's Hospital
San Francisco, California, United States
Morehouse School of Medicine
Atlanta, Georgia, United States
Boston Medical Center
Boston, Massachusetts, United States
NYU Langone Health Lake Success
Lake Success, New York, United States
UNC-Chapel Hill School of Medicine
Chapel Hill, North Carolina, United States
Atrium Health Levine Children's
Charlotte, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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855107
Identifier Type: OTHER
Identifier Source: secondary_id
24-0699
Identifier Type: -
Identifier Source: org_study_id
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