Digital Care for Inflammatory Bowel Disease

(PROMOTE IBD Trial)

Enrolling by invitation at 7 trial locations

Overseen By Margie E Boccieri, MA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Current pouch, Ostomy, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if individuals with Inflammatory Bowel Disease (IBD), such as Crohn's disease or ulcerative colitis, manage their health better through Enhanced Digital Care, a digital health intervention that includes texting their medical team and receiving regular updates on their symptoms. Participants will be divided into two groups: one will receive educational texts and regular symptom check-ins, while the other will receive only educational texts. The trial will also examine how social factors influence IBD symptoms and quality of life. Suitable candidates have an IBD diagnosis, have visited their doctor in the past year, and can text in English or Spanish. As an unphased trial, this study provides a unique opportunity to contribute to innovative digital health solutions for IBD management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on text-based communication and monitoring rather than medication changes.

What prior data suggests that this digital care method is safe for IBD patients?

Research has shown that digital health tools for managing inflammatory bowel disease (IBD) are generally safe for users. In past studies, patients using similar digital systems, such as online chats linked to their health records, reported no major safety issues. These tools help track symptoms and facilitate communication with healthcare providers.

Additionally, a review of various digital health tools found that IBD patients manage them well, with no serious problems associated with their use. Patients using digital systems to monitor their condition did not experience more side effects than those receiving regular care. Overall, evidence suggests that digital tools for IBD management are safe and can help patients feel more in control of their health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Enhanced Digital Care for inflammatory bowel disease (IBD) because it leverages technology to provide personalized support. Unlike traditional treatments that focus on medication, this approach uses regular text message check-ins to monitor symptoms and delivers educational content, aiming to empower patients with knowledge about their condition. This digital method could improve patient engagement and symptom management without the need for frequent in-person visits, offering a more convenient and proactive way to manage IBD.

What evidence suggests that this digital care method is effective for managing IBD?

This trial will compare Enhanced Digital Care with Specialized Education for managing Inflammatory Bowel Disease (IBD). Studies have shown that digital health tools can manage IBD more effectively. Research indicates that technologies like text messages and online surveys improve patient care by enabling regular symptom tracking. This allows doctors to adjust treatments as needed. One study found that patients using digital tools felt more involved in their care, which can lead to better health outcomes. Overall, digital care appears to empower patients and improve IBD management. ^{1 2 3 4 5}

Who Is on the Research Team?

Michael D Kappelman, MD, MPH

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals with Crohn's Disease, Ulcerative Colitis, or other forms of Inflammatory Bowel Disease. Participants should be willing to complete online surveys and receive educational content via text messages. The eligibility criteria are not fully listed here.

Inclusion Criteria

I can use a mobile phone and respond to texts.

I am 13 or older and have IBD (Crohn's, ulcerative colitis, or indeterminant colitis).

Followed at a participating site with an office visit (in-person or virtual) within the preceding 12 months

Exclusion Criteria

I have IBD and have had surgery resulting in a pouch or ostomy.

Unable to provide informed consent and child assent for minors

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline surveys including demographic information, social risk assessment, and patient-reported outcomes

1 week

1 visit (virtual)

Intervention

Participants receive text-based education and monitoring. Enhanced care arm participants receive additional surveys and text communication with their clinical team.

12 months

Monthly virtual check-ins, weekly if severe symptoms reported

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Digital Care

Trial Overview The study tests if regular text-based symptom monitoring and communication with the clinical team can improve disease management in IBD patients compared to those only receiving educational texts. It also explores how social factors affect IBD symptoms and life quality.

How Is the Trial Designed?

Group I: Enhanced Digital Care Arm Active Control 2 Interventions

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.

Group II: Specialized Education Arm Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

A review of 68 articles identified 11 digital health apps specifically for inflammatory bowel disease (IBD), which primarily focus on patient-reported outcomes and education, showing significant benefits in quality of life and treatment adherence without any reported negative impacts.

While digital health apps can enhance standard clinical care for IBD patients, further validation and research are needed to optimize their effectiveness and integration into healthcare, particularly through innovative methods like microrandomized trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health Apps in the Clinical Care of Inflammatory Bowel Disease: Scoping Review. Yin, AL., Hachuel, D., Pollak, JP., et al.[2023]

Digital health technologies, such as web-based interventions and mobile applications, can reduce health care utilization and costs for patients with inflammatory bowel diseases (IBD), based on a review of 14 randomized controlled trials involving a median of 98 patients.

However, these digital interventions do not significantly improve disease activity, quality of life, or treatment adherence compared to standard care, indicating that while they may help manage costs, they do not enhance overall treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health Technologies for Remote Monitoring and Management of Inflammatory Bowel Disease: A Systematic Review. Nguyen, NH., Martinez, I., Atreja, A., et al.[2023]

A study involving 100 patients with inflammatory bowel disease showed that using smartphone apps for monitoring symptoms and biomarkers is as effective as standard face-to-face care in maintaining quality of life and symptom management over 12 months.

The use of smartphone apps significantly reduced the number of outpatient appointments needed, indicating a more efficient management approach for patients in remission, particularly for those with mild-to-moderate disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Noninferiority Randomized Clinical Trial of the Use of the Smartphone-Based Health Applications IBDsmart and IBDoc in the Care of Inflammatory Bowel Disease Patients. McCombie, A., Walmsley, R., Barclay, M., et al.[2021]

Patients with Inflammatory Bowel Disease (IBD) demonstrated excellent accuracy in self-reporting their medical history, particularly regarding the type of disease and surgical history, with kappa statistics indicating strong agreement (κ=0.96-0.97).

However, the reliability of self-reported details decreased for more complex medical information, such as partial colectomy, and those with higher disease knowledge were more accurate in reporting disease location, suggesting that knowledge assessment could help identify reliable respondents in internet-based surveys.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The accuracy of self-reported medical history: a preliminary analysis of the promise of internet-based research in Inflammatory Bowel Diseases. Kelstrup, AM., Juillerat, P., Korzenik, J.[2022]

The Tappt digital health system is designed to monitor real-time medication adherence in patients with inflammatory bowel diseases (IBDs) using smart label technology, which could help identify and address reasons for nonadherence.

A 12-month randomized controlled trial will assess the effectiveness of this system in improving medication adherence, clinical outcomes, and healthcare use compared to standard care, with an expected enrollment of 123 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and Persistence With Inflammatory Bowel Disease Therapy (ASSIST Study): Protocol for a Randomized Controlled Trial. Axelrad, J., Long, M., Horst, S., et al.[2023]

The use of the HealthPROMISE digital health monitoring platform led to a significant reduction in IBD-related emergency room visits and hospitalizations, decreasing from 25% to 3% among patients who logged into the app at least once during the study.

Patients reported improved understanding of their condition after using the app, indicating that digital health tools can enhance patient education and engagement, although no significant changes were observed in quality indicators or symptom scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Digital Health Monitoring in the Management of Inflammatory Bowel Disease. Zhen, J., Marshall, JK., Nguyen, GC., et al.[2022]

A pilot study involving 15 participants showed that using patient-reported outcomes measures (PROMs) through an electronic platform for self-management in IBD care was well-accepted, with 10 participants feeling 'well' or 'well with questions'.

The implementation of PROMs in outpatient settings allowed for real-time tracking of quality of life and disease activity, enabling remote management of well patients and potentially increasing efficiency in outpatient services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using e-health tools and PROMs to support self-management in patients with inflammatory bowel disease. Avery, P.[2022]

The study found that emotional distress was a significant factor differentiating users and non-users of digital patient-reported outcomes among people with Inflammatory Bowel Disease (IBD), with a moderate effect size (d = 0.45).

Cluster analysis revealed that users and non-users have different challenges and reservations regarding digital health solutions, suggesting that understanding these differences could enhance the acceptability and effectiveness of digital tools in managing IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Readiness, acceptance and use of digital patient reported outcome in an outpatient clinic. Nielsen, AS., Hanna, L., Larsen, BF., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10599806/

A Digital Health Intervention to Improve the Clinical Care of ... We developed the IBD Virtual Care Chat, an electronic health record (EHR)-integrated chat to monitor electronic patient reported outcomes (ePROs), medication ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589750024002905

Efficacy of digital health technologies in the management ... In this umbrella review, we investigated the effectiveness of DHT in the care of patients with IBD and identified areas for future research.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07159776

Multiple Digital Biomarkers for Optimization of IBD Care The trial aims to develop digital biomarkers based on a large dataset of imput data. These data come from diffent sources including wearable data, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8987011/

Digital Health Technologies for Remote Monitoring and ... We performed a systematic review of digital health interventions in the management of patients with inflammatory bowel diseases (IBD) and evaluated its impact.

5. academic.oup.com academic.oup.com/ecco-jcc/article/17/10/1596/7143403

Management of Inflammatory Bowel Disease Using E-health ... We conducted a systematic review to compare e-health interventions with standard care in management of IBD.