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

Not Applicable

Recruiting

• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Colitis; Ulcerative Colitis
• Interventions: Other: Enhanced Digital Care; Other: Education

• Registration Number: NCT06424769
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Study Timeline

• Study First Submitted: 2024-05-13
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-22
• Study Start: 2024-07-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced Digital Care Arm	Education	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.
Specialized Education Arm	Education	Participants in this arm will receive IBD educational text messages twice each week.
Enhanced Digital Care Arm	Enhanced Digital Care	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.

Primary Outcome Measures

Name	Time	Method
Change in Patient Activation using PAM	Baseline, 12 months	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.

Secondary Outcome Measures

Name	Time	Method
IBD-Related Quality of Life	up to 12 months	IBD-related quality of life will be measured using the Short Inflammatory Bowel Disease Questionnaire (SIBDQ), a validated, 10-item questionnaire which measures quality of life across physical, social and emotional domains in patients with IBD. The score on this questionnaire ranges from 10 to 70, with a minimal clinically important difference (MCID) of 9 points. This will be measured at baseline and at 12 months.
Unplanned Healthcare Utilization	up to 12 months	Unplanned healthcare utilization (defined as IBD-related Emergency Department (ED) visit, hospitalization, or abdominal/perianal surgery for IBD) will be measured by self-report every 3 months (Baseline and months 3, 6, 9, and 12).
Remission at 52 Weeks	12 months	Proportion of participants achieving Patient Reported Outcome (PRO) remission without steroids at end of study (among participants with active disease at baseline). This will be assessed for ulcerative colitis patients based on the 2-point PRO2-UC and assessed for Crohn's disease patients using the 2-point PRO2-CD. The PRO2-UC consists of the stool frequency and rectal bleeding subscores of the Mayo Clinic Score, and remission is defined as absence of rectal bleeding (rectal bleeding score = 0) and normal or near normal stool frequency (stool frequency score ≤1). The PRO2-CD consists of the 2 Crohn's Disease Activity Index (CDAI) component items: daily stool frequency and abdominal pain, and remission is defined as mean daily score of abdominal pain score ≤1 and stool frequency score ≤3.

Trial Locations

Locations (8)

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