Digital Care for Inflammatory Bowel Disease

(PROMOTE IBD Trial)

Recruiting 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

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is digital care for inflammatory bowel disease safe for humans?

The studies reviewed did not report any safety concerns related to the use of digital health monitoring platforms for inflammatory bowel disease, suggesting that these digital tools are generally safe for human use. ^{1 2 3 4 5}

How is the Enhanced Digital Care treatment for inflammatory bowel disease different from other treatments?

Enhanced Digital Care for inflammatory bowel disease is unique because it uses digital health technologies to monitor disease activity and medication adherence in real-time, improving patient self-management and reducing hospital visits. This approach leverages mobile apps and smart technologies to provide personalized care and support between clinical visits, unlike traditional treatments that may not offer such continuous monitoring and interaction. ^{1 3 6 7 8}

What data supports the effectiveness of the treatment Enhanced Digital Care, Text-Based Monitoring, Digital Health Intervention, Enhanced Electronic Healthcare for Inflammatory Bowel Disease?

Research shows that digital health technologies can help manage inflammatory bowel disease by improving disease monitoring, treatment adherence, and quality of life. Studies have found that using smartphone apps and digital platforms can reduce emergency room visits and hospitalizations, indicating better management of the condition. ^{1 3 4 5 8}

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

Unable to provide informed consent and child assent for minors

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

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

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Digital Health Technologies for Remote Monitoring and Management of Inflammatory Bowel Disease: A Systematic Review. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Readiness, acceptance and use of digital patient reported outcome in an outpatient clinic. [2022]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of Digital Health Monitoring in the Management of Inflammatory Bowel Disease. [2022]

5. England pubmed.ncbi.nlm.nih.gov

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

6. England 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. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Digital Health Apps in the Clinical Care of Inflammatory Bowel Disease: Scoping Review. [2023]

8. Canada 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. [2023]