Clinical trial NCT06424769: Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management
Official title: Improving Outcomes and Reducing Disparities for Patients With Inflammatory Bowel Disease Through Epidemiology and Enhanced Disease Management (PROMOTE IBD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Colitis
Keywords: Text Messaging
Symptom Monitoring
Social Risk Factors
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Centers for Disease Control and Prevention
First posted: 2024-05-22
Enrollment: 900
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Crohn's disease (CD) and ulcerative colitis (UC), collectively referred to as inflammatory bowel diseases (IBD), are chronic diseases with no cure. Patient activation, defined as having the knowledge, skill, and confidence to manage one's health, can improve outcomes in chronic diseases, including IBD. Tailored digital health interventions can facilitate proactive longitudinal care for IBD patients by improving patient activation, promoting self-management and remote monitoring and can be automated and implemented at scale.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Patient Activation using PAM
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Remission at 52 Weeks
timeFrame: 12 months
measure: IBD-Related Quality of Life
timeFrame: up to 12 months
measure: Unplanned Healthcare Utilization
timeFrame: up to 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Benioff Children's Hospital
state: California
city: Atlanta
country: United States
facility: Morehouse School of Medicine
state: Georgia
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Lake Success
country: United States
facility: NYU Langone Health Lake Success
state: New York
city: Chapel Hill
country: United States
facility: UNC-Chapel Hill School of Medicine
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health Levine Children's
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Michael D Kappelman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.