40 Participants NeededMy employer runs this trial

Digital Self-Management for Inflammatory Bowel Disease

SC
Overseen ByShirley Cohen-Mekelburg, MD, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a digital program can help people manage their inflammatory bowel disease (IBD) and improve their daily lives. The researchers aim to determine if combining this digital self-management program with standard care can positively impact how participants feel and manage their condition. Participants will receive either regular care or regular care plus access to the digital self-management program for 24 weeks. Individuals diagnosed with IBD, who experience regular symptoms, and whose quality of life is affected by the condition might be a good fit for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance IBD management and improve quality of life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this digital self-management program is safe for individuals with inflammatory bowel disease?

Research has shown that digital self-management programs for inflammatory bowel disease (IBD) are generally safe for participants. For example, a review of several digital health tools used in IBD care found that patients tolerated them well. These programs reported no major side effects, suggesting they are safe to use alongside regular treatment.

One study examined the MyGut digital health monitoring platform, which was added to IBD care without causing harm. This indicates that digital tools can safely complement traditional treatments for IBD.

Overall, existing studies suggest that digital self-management programs pose minimal risk to participants and are safe for managing IBD symptoms.12345

Why are researchers excited about this trial?

Researchers are excited about the digital self-management program for inflammatory bowel disease (IBD) because it offers a novel way for patients to actively manage their condition. Unlike traditional treatments like medication or dietary changes, this program empowers patients with digital tools to track symptoms, manage stress, and adjust lifestyle choices in real-time. Additionally, integrating this program with standard care could enhance treatment outcomes by providing personalized support and fostering better patient engagement. This innovative approach has the potential to improve quality of life and long-term disease management for individuals with IBD.

What evidence suggests that this digital self-management program is effective for inflammatory bowel disease?

Research shows that digital self-management programs can help people with inflammatory bowel disease (IBD). In this trial, participants will receive either standard care or standard care plus a digital self-management program. Studies have found that these programs can improve patients' quality of life and reduce symptoms. A review of various studies found that digital health tools aid in managing IBD by promoting regular medication adherence and reducing emergency visits. Another study found that patients using digital tools felt more energetic and healthier overall. These findings suggest that digital self-management could effectively manage IBD symptoms.26789

Who Is on the Research Team?

SC

Shirley Cohen-Mekelburg, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for people diagnosed with Crohn's disease or ulcerative colitis (types of inflammatory bowel disease) who currently have active symptoms and a lower quality of life due to their condition.

Inclusion Criteria

I have been diagnosed with active inflammatory bowel disease.
* Impaired health-related quality of life
My Crohn's or ulcerative colitis is currently active.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 24-week digital self-management program to improve health outcomes for inflammatory bowel disease

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Digital self-management program

Trial Overview

The study compares a digital self-management program designed to help patients manage their IBD at home, versus standard medical care. Participants are randomly assigned to one of the two groups.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Standard Care plus digital self-management programExperimental Treatment2 Interventions
Group II: Standard careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials
1,891
Recruited
6,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

Effectiveness of self-management intervention program based ...

Data are collected via self-report online questionnaires, except for disease activity and healthcare resource utilization, which are assessed by ...

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.

Protocol for a Hybrid Effectiveness-Implementation Study

We will assess effectiveness through changes in key outcomes such as health care utilization (eg, emergency visits, hospitalizations), disease ...

Digital Therapeutic Self-Management Intervention in ... - PMC

In inflammatory bowel disease (IBD), 88% of adolescents demonstrate significant medication nonadherence, with approximately 40%–50% missed doses (4). These data ...

A New Digital Health Program for Patients With Inflammatory ...

This study aimed to perform a preliminary program evaluation, analyzing engagement and preliminary effectiveness and the effect on participants' energy levels.

Digital patient-reported outcomes in inflammatory bowel ...

This study aimed to explore hospital clinicians' attitudes towards digital patient-reported outcomes used in the routine care and treatment of inflammatory ...

A Novel Digital Self-management Intervention for Symptoms of ...

This paper aimed to describe the process of developing a supported digital self-management intervention for fatigue, pain, and urgency in IBD

Digital Health Monitoring Platforms Feasible for IBD ...

The MyGut digital health monitoring platform proves feasible and impactful during integration into inflammatory bowel disease care.

Digital Health Technologies for Remote Monitoring and ... - PMC

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